Medical Devices; Exemptions From Premarket Notification: Class II Devices

---
identifier: "/us/fr/2017-14453"
source: "fr"
legal_status: "authoritative_unofficial"
title: "Medical Devices; Exemptions From Premarket Notification: Class II Devices"
title_number: 0
title_name: "Federal Register"
section_number: "2017-14453"
section_name: "Medical Devices; Exemptions From Premarket Notification: Class II Devices"
positive_law: false
currency: "2017-07-11"
last_updated: "2017-07-11"
format_version: "1.1.0"
generator: "[email protected]"
agency: "Health and Human Services Department"
document_number: "2017-14453"
document_type: "notice"
publication_date: "2017-07-11"
agencies:
  - "Health and Human Services Department"
  - "Food and Drug Administration"
fr_citation: "82 FR 31976"
fr_volume: 82
docket_ids:
  - "Docket No. FDA-2017-N-1129"
fr_action: "Notice."
---


#  Medical Devices; Exemptions From Premarket Notification: Class II Devices

**AGENCY:**

Food and Drug Administration, HHS.

**ACTION:**

Notice.

**SUMMARY:**

The Food and Drug Administration (FDA or Agency) is announcing a list of class II devices that the Agency has determined based on established factors to no longer require premarket notification to provide reasonable assurance of safety and effectiveness, subject to certain limitations. FDA is publishing this notice of that determination in accordance with procedures established by the 21st Century Cures Act. This notice represents FDA's final determination with respect to the list of class II devices proposed in a March 14, 2017, *Federal Register* document. The exemptions in this notice will decrease regulatory burdens on the medical device industry and will eliminate private costs and expenditures required to comply with certain Federal regulations.

**FOR FURTHER INFORMATION CONTACT:**

Bryce Bennett, Center for Devices and Radiological Health, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 66, Rm. 5244, Silver Spring, MD 20993, email: *[email protected].*

**SUPPLEMENTARY INFORMATION:**

**I. Background**

In the *Federal Register* of March 14, 2017 (82 FR 13609), FDA issued a notice proposing to exempt a list of class II devices from the premarket notification requirements under section 510(k) of the Federal Food, Drug, and Cosmetic Act (the FD&C Act) (21 U.S.C. 360(k)), subject to certain limitations. This notice was issued in accordance with the 21st Century Cures Act (Pub. L. 114-255), which was signed into law on December 13, 2016. Section 3054 of that statute amended section 510(m) of the FD&C Act. As amended, section 510(m)(1)(A) of the FD&C Act provides that, within 90 days after enactment of the 21st Century Cures Act and at least once every 5 years thereafter, FDA must publish in the *Federal Register* a notice containing a list of each type of class II device that FDA determines no longer requires a report under section 510(k) of the FD&C Act (generally referred to as a premarket notification or “510(k)”) to provide reasonable assurance of safety and effectiveness. Within 210 days of enactment of the 21st Century Cures Act, FDA must publish in the *Federal Register* a list representing its final determination regarding the list of devices proposed in the March 14, 2017, notice. Section 510(m)(3) of the FD&C Act provides that upon the date that this final list is published in the *Federal Register* , a 510(k) will no longer be required for the listed devices and the applicable classification regulation for these devices shall be deemed amended to incorporate such exemption. Interested persons were given until May 15, 2017, to comment on the proposed list of class II devices. After reviewing these comments and considering whether the proposed list should be modified, FDA is now identifying its final determination as to which of those devices are now exempt from premarket notification requirements, subject to certain limitations, as indicated in tables 1 to 3 of this notice.

In a future action, FDA intends to amend the codified language for each listed device's classification regulation to reflect this final determination. Persons with pending 510(k) submissions for devices that are now exempt from premarket notification, subject to the limitations on exemptions, should withdraw their submissions.

These exemptions will decrease regulatory burdens on the medical device industry and will eliminate private costs and expenditures required to comply with Federal regulation. Specifically, regulated industry will no longer have to invest time and resources in premarket notifications, including preparation of documents and data for submission to FDA, payment of user fees associated with 510(k) submissions, and responding to questions and requests for additional information from FDA during 510(k) review.

**II. Criteria for Exemption**

There are a number of factors FDA may consider to determine whether a 510(k) is necessary to provide reasonable assurance of the safety and effectiveness of a class II device. These factors are discussed in the January 21, 1998, *Federal Register* notice (63 FR 3142) and subsequently in the guidance the Agency issued on February 19, 1998, entitled “Procedures for Class II Device Exemptions from Premarket Notification, Guidance for Industry and CDRH Staff” (“Class II 510(k) Exemption Guidance”) (Ref. 1).

**III. Limitations on Exemptions**

FDA believes that the types of class II devices listed in this notice should be exempt from the premarket notification requirements found under section 510(k) of the FD&C Act. However, an exemption from the requirement of premarket notification does not mean that the device is exempt from any other statutory or regulatory requirements, unless such exemption is explicitly provided by order or regulation. FDA's determination that premarket notification is unnecessary to provide a reasonable assurance of safety and effectiveness for devices listed in this document is based, in part, on the assurance of safety and effectiveness that other regulatory controls, such as current good manufacturing practice requirements, provide.

In addition to being subject to the general limitations to the exemptions found in Title 21 of the Code of Federal Regulations (CFR) sections 862.9 to 892.9 (§§ 862.9 to 892.9), when Agency assessment determines that the factors laid out in the Class II 510(k) Exemption Guidance (Ref. 1) do not weigh in favor of exemption for all devices in a particular group, FDA may partially limit the exemption from premarket notification requirements to specific devices within a listed device type. In such situations where a partial exemption limitation has been identified, FDA has determined that premarket notification is necessary to provide a reasonable assurance of safety and effectiveness for these devices. Partial exemption limitations can be found in table 2 of this notice. FDA has assigned new product codes to the device types that are now exempt subject to the partial limitations in order to ensure that these devices can be separated from devices that do not fall within the partial exemption limitation under the existing product code ( *i.e.,* exempt and non-exempt devices within a device type will have distinct product codes). If table 2 indicates that a partial exemption limitation does apply to a device, then affected device manufacturers should review their registration and listing information to assess if they should list their device using the original classification product code, which requires premarket notification, or the new classification product code for the subset of that device type that is now 510(k) exempt (subject to the general limitations to the exemptions found in §§ 862.9 to 892.9). In table 2, for example, FDA is listing the exemption of the tympanometer but limits the exemption to such devices that are in compliance with FDA-recognized consensus standard ANSI S3.39. Tympanometers that comply with this partial exemption limitation and the corresponding general limitations in § 874.9 are now exempt from the 510(k) requirements and should be identified under new product code “PTP” in subsequent registration and listing submissions. However, tympanometers not in compliance with each of these exemption limitations remain subject to the 510(k) requirements and will retain product code “NAS.” We recommend that device manufacturers document in their records any changes in the product code of their device with appropriate justification.

**IV. List of Class II Devices**

In table 1, FDA is identifying the following list of class II devices that no longer require premarket notification under section 510(k) of the FD&C Act, subject to the general limitations to the exemptions found in §§ 862.9 to 892.9:

| 21 CFR section | Device type | Product code |
| --- | --- | --- |
| 862.1020 | Acid Phosphatase, Nitrophenylphosphate | CJN |
| 862.1020 | Acid Phosphatase, Thymol Blue Monophosphate | CJR |
| 862.1020 | Acid Phosphatase, Disodium Phenylphosphate | CJX |
| 862.1020 | Acid Phosphatase, Naphthyl Phosphate | CKB |
| 862.1020 | Acid Phosphatase, Thymolphthale Inmonophosphate | CKE |
| 862.1020 | Acid Phosphatase, Beta Glycerophosphate | CKH |
| 862.1020 | Acid Phosphatase (Prostatic), Tartrate Inhibited | JFH |
| 862.1090 | Radioassay, Angiotensin Converting Enzyme | KQN |
| 862.1100 | Vanillin Pyruvate, AST/SGOT | CIF |
| 862.1100 | Diazo, AST/SGOT | CIQ |
| 862.1100 | Hydrazone Colorimetry, AST/SGOT | CIS |
| 862.1100 | NADH Oxidation/NAD Reduction, AST/SGOT | CIT |
| 862.1150 | Calibrator, Primary | JIS |
| 862.1150 | Calibrator, Secondary | JIT |
| 862.1150 | Calibrator, Surrogate | JIW |
| 862.1150 | Calibrator, Multi-Analyte Mixture | JIX |
| 862.1345 | Drink, Glucose Tolerance | MRV |
| 862.1350 | Continuous Glucose Monitor Secondary Display | PJT |
| 862.1445 | Chromatographic Separation, Lactate Dehydrogenase Isoenzymes | CEX |
| 862.1445 | Electrophoretic, Lactate Dehydrogenase Isoenzymes | CFE |
| 862.1445 | Differential Rate Kinetic Method, Lactate Dehydrogenase Isoenzymes | JGF |
| 862.1509 | System, Test, Urinary Methylmalonic Acid | LPT |
| 862.1685 | Radioimmunoassay, Thyroxine-Binding Globulin | CEE |
| 862.1700 | Radioimmunoassay, Total Thyroxine | CDX |
| 862.1700 | Enzyme Immunoassay, Non-Radiolabeled, Total Thyroxine | KLI |
| 862.2265 | High Throughput DNA Sequence Analyzer | PFF |
| 862.2570 | Instrumentation For Clinical Multiplex Test Systems | NSU |
| 862.2570 | Real Time Nucleic Acid Amplification System | OOI |
| 862.2570 | Mass Spectrometer For Clinical Multiplex Test Systems | OTA |
| 862.2570 | Micro Total Analysis Instrument System | OUE |
| 862.2570 | Complete Gene Expression Profiling Accessory Reagents | OVA |
| 862.2570 | DNA Genetic Analyzer | PCA |
| 862.2570 | Data Acquisition Software | PQQ |
| 862.3200 | Calibrators, Drug Mixture | DKB |
| 862.3200 | Calibrators, Drug Specific | DLJ |
| 862.3200 | Calibrators, Ethyl Alcohol | DNN |
| 864.5400 | Fibrometer | GIE |
| 864.5400 | Timer, Coagulation | JBT |
| 864.5425 | Control, Plasma, Abnormal | GGC |
| 864.5425 | Plasma, Coagulation Control | GGN |
| 864.5425 | Plasma, Control, Normal | GIZ |
| 864.6550 | Control, Fecal Occult Blood | OSL |
| 864.6650 | Study, Platelet Adhesive | JBZ |
| 864.7275 | Test, Euglobulin Lysis | JBO |
| 864.7300 | Fibrin Monomer Paracoagulation | JBN |
| 864.7340 | Fibrinogen Standard | GFX |
| 864.7340 | Plasma, Fibrinogen Control | GIL |
| 864.7375 | Glutathione, Red-Cell | GII |
| 864.7375 | Fluorescence, Visual Observation (Qual., U.V.), Glutathione Reductase | JMH |
| 864.7375 | Assay, Glutathione Reductase | KQF |
| 864.7415 | Control, Hemoglobin, Abnormal | JCM |
| 864.7455 | Stain, Fetal Hemoglobin | GHQ |
| 864.7500 | Acid Hematin | GGF |
| 864.7720 | Test, Prothrombin Consumption | GGQ |
| 864.7735 | Prothrombin-Proconvertin and Thrombotest | JPF |
| 864.8150 | Calibrator for Cell Indices | KRX |
| 864.8165 | Calibrator for Hemoglobin and Hematocrit Measurement | KRZ |
| 864.8175 | Calibrator for Platelet Counting | KRY |
| 864.8185 | Calibrator for Red-Cell and White-Cell Counting | KSA |
| 864.8625 | Standards and Controls, Hemoglobin, Normal and Abnormal | GFS |
| 864.8625 | Control, White-Cell | GGL |
| 864.8625 | Control, Hemoglobin | GGM |
| 864.8625 | Control, Platelet | GJP |
| 864.8625 | Control, Red-Cell | GJR |
| 864.8625 | Control, Hematocrit | GLK |
| 864.8625 | Mixture, Control, White-Cell and Red-Cell Indices | GLQ |
| 864.8625 | Control, Cell Counter, Normal and Abnormal | JCN |
| 864.8625 | Mixture, Hematology Quality Control | JPK |
| 864.8625 | Material, Quality Control, Semen Analysis | NRF |
| 864.8625 | Control Material, Blood Circulating Epithelial Cancer Cell | NRS |
| 864.9400 | Solution, Stabilized Enzyme | KSK |
| 866.3395 | Norovirus Serological Reagents | OUC |
| 866.5210 | Immunochemical, Ceruloplasmin | CHN |
| 866.5210 | Ceruloplasmin, Rhodamine, Antigen, Antiserum, Control | DCT |
| 866.5210 | Ceruloplasmin, FITC, Antigen, Antiserum, Control | DCY |
| 866.5210 | Ceruloplasmin, Antigen, Antiserum, Control | DDB |
| 866.5210 | P-Phenyl-Enediamine/EDTA (Spectrophotometric), Ceruloplasmin | JFQ |
| 866.5210 | Indirect Copper Assay, Ceruloplasmin | JFR |
| 866.5470 | Hemoglobin, Chain Specific, Antigen, Antiserum, Control | DAM |
| 866.5620 | -2-Macroglobulin, Rhodamine, Antigen, Antiserum, Control | DDT |
| 866.5620 | -2-Macroglobulin, FITC, Antigen, Antiserum, Control | DDY |
| 866.5620 | -2-Macroglobulin, Antigen, Antiserum, Control | DEB |
| 866.5630 | System, Test, 
                            
                            -2-Microglobulin Immunological | JZG |
| 866.5910 | Quality Control Material, Genetics, DNA | NZB |
| 868.1040 | Algesimeter, Powered | BSI |
| 868.1400 | Legging, Compression, Non-Inflatable | LLK |
| 868.2500 | Monitor, Oxygen, Cutaneous, For Infant Not Under Gas Anesthesia | KLK |
| 868.2500 | Monitor, Oxygen, Cutaneous, For Uses Other Than For Infant Not Under Gas Anesthesia | LPP |
| 868.2550 | Pneumotachometer | JAX |
| 868.5180 | Bed, Rocking, Breathing Assist | CCO |
| 868.6250 | Compressor, Air, Portable | BTI |
| 870.1390 | Trocar | DRC |
| 870.1875 | Lung Sound Monitor | OCR |
| 870.2675 | Oscillometer | DRZ |
| 870.4280 | Filter, Prebypass, Cardiopulmonary Bypass | KRJ |
| 870.4290 | Adaptor, Stopcock, Manifold, Fitting, Cardiopulmonary Bypass | DTL |
| 870.4340 | Monitor and/or Control, Level Sensing, Cardiopulmonary Bypass | DTW |
| 870.4420 | Sucker, Cardiotomy Return, Cardiopulmonary Bypass | DTS |
| 870.4430 | Suction Control, Intracardiac, Cardiopulmonary Bypass | DWD |
| 872.1720 | Tester, Pulp | EAT |
| 872.3260 | External Cleaning Solution | PME |
| 872.3300 | Coating, Denture Hydrophilic, Resin | EBE |
| 872.3540 | Pad, Denture, Over The Counter | EHR |
| 872.3540 | Cushion, Denture, Over The Counter | EHS |
| 872.3560 | Reliner, Denture, Over The Counter | EBP |
| 872.3590 | Denture, Plastic, Tooth | ELM |
| 872.3600 | Denture Preformed (Partially Prefabricated Denture) | EKO |
| 872.3890 | Splint, Endodontic Stabilizing | ELS |
| 872.5550 | Ring, Teething, Fluid-Filled | KKO |
| 872.6770 | Syringe, Cartridge | EJI |
| 874.1120 | Generator, Electronic Noise (for Audiometric Testing) | ETS |
| 874.1325 | Electroglottograph | KLX |
| 874.3310 | Calibrator, Hearing Aid/Earphone and Analysis Systems | ETW |
| 874.3320 | Hearing Aid, Group and Auditory Trainer | EPF |
| 874.3320 | Device, Assistive Listening | LZI |
| 874.3330 | Hearing Aid, Master | KHL |
| 874.3430 | Mold, Middle-Ear | ETC |
| 874.3730 | Device, Voice Amplification | MCK |
| 876.1500 | Light Source, Incandescent, Diagnostic | FCQ |
| 876.1500 | Light Source, Photographic, Fiberoptic | FCR |
| 876.1500 | Light Source, Fiberoptic, Routine | FCW |
| 876.1500 | Carrier, Sponge, Endoscopic | FGS |
| 876.1500 | Light Source, Endoscope, Xenon Arc | GCT |
| 876.1500 | Transformer, Endoscope | GCW |
| 876.1500 | LED Light Source | NTN |
| 876.1500 | Endoscopic Guide Wire, Gastroenterology-Urology | OCY |
| 876.4020 | Light, Catheter, Fiberoptic, Glass, Ureteral | FCS |
| 876.4270 | Rod, Colostomy | EZP |
| 876.4400 | Ligator, Hemorrhoidal | FHN |
| 876.4400 | Ligator, Esophageal | MND |
| 876.4500 | Lithotriptor, Biliary Mechanical | LQC |
| 876.4770 | Urethrotome | EZO |
| 876.5010 | Bag, Bile Collecting | EXF |
| 876.5025 | Vibrator for Climax Control of Premature Ejaculation | PIA |
| 876.5365 | Dilator, Esophageal (Metal Olive) Gastro-Urology | EZM |
| 876.5365 | Bougie, Esophageal, and Gastrointestinal, Gastro-Urology | FAT |
| 876.5365 | Dilator, Esophageal | KNQ |
| 876.5520 | Dilator, Urethral | KOE |
| 876.5665 | Disinfectant, Subsystem, Water Purification | NIH |
| 876.5820 | Set, Dialyzer Holder | FKI |
| 876.5895 | Irrigator, Ostomy | EXD |
| 876.5980 | Catheter, Retention, Barium Enema With Bag | FGD |
| 876.5980 | Gastrostomy Tube Holder | PLI |
| 878.4370 | Drape, Surgical, ENT | ERY |
| 878.4370 | Drape, Pure Latex Sheet, With Self-Retaining Finger Cot | EYX |
| 878.4370 | Drape, Urological, Disposable | EYY |
| 878.4370 | Pad, Kelly | FNW |
| 878.4370 | Drape, Patient, Ophthalmic | HMT |
| 878.4370 | Drape, Microscope, Ophthalmic | HMW |
| 878.4370 | Ring (Wound Protector), Drape Retention, Internal | KGW |
| 878.4580 | Lamp, Operating-Room | FQP |
| 878.4580 | Light, Surgical, Instrument | FSQ |
| 878.4580 | Light, Surgical, Floor Standing | FSS |
| 878.4580 | Light, Surgical, Endoscopic | FSW |
| 878.4580 | Light, Surgical, Connector | FSX |
| 878.4580 | Light, Surgical, Ceiling Mounted | FSY |
| 878.4580 | Light, Surgical, Carrier | FSZ |
| 878.4580 | Light, Surgical, Accessories | FTA |
| 878.4580 | Lamp, Surgical | FTD |
| 878.4580 | Illuminator, Remote | FTG |
| 878.4580 | Lamp, Surgical, Incandescent | GBC |
| 878.5070 | Apparatus, Air Handling, Bench | FZG |
| 878.5070 | Apparatus, Air Handling, Room | FZH |
| 878.5070 | Apparatus, Air Handling, Enclosure | FZI |
| 880.5580 | Locator, Acupuncture Point | BWJ |
| 880.5580 | Needle, Acupuncture, Single Use | MQX |
| 880.5780 | Stocking, Medical Support (to Prevent Pooling of Blood in Legs) | DWL |
| 882.1020 | Analyzer, Rigidity | GZM |
| 882.1540 | Device, Galvanic Skin Response Measurement | GZO |
| 882.1560 | Device, Skin Potential Measurement | HCJ |
| 882.1855 | Encephalogram Telemetry System | GYE |
| 882.5895 | Vibratory Counter-Stimulation | OVP |
| 884.2990 | Sheet, Recording, Breast Examination | NHM |
| 884.3200 | Drain, Cervical | HFL |
| 884.4400 | Forceps, Obstetrical | HDA |
| 884.4530 | Clamp, Umbilical | HFW |
| 884.4530 | Speculum, Vaginal, Nonmetal | HIB |
| 884.4530 | Speculum, Vaginal, Nonmetal, Fiberoptic | HIC |
| 884.4530 | Clamp and Cutter, Umbilical | NBZ |
| 884.4900 | Table, Obstetrical, AC-Powered (and Accessories) | HDD |
| 884.4900 | Table, Obstetrical, Manual (and Accessories) | HHP |
| 884.4900 | Table, Obstetric (and Accessories) | KNC |
| 884.5200 | Hemorrhoid Prevention Pressure Wedge | OOA |
| 884.5390 | Heater, Perineal, Direct Contact | HGZ |
| 884.5390 | Heater, Perineal, Radiant, Non-Contact | HHA |
| 884.5390 | Heater, Perineal | KND |
| 884.5400 | Cup, Menstrual | HHE |
| 884.5425 | Pad, Menstrual, Scented | HHL |
| 884.6150 | Micromanipulators and Microinjectors, Assisted Reproduction | MQJ |
| 886.1120 | Photorefractor | MMF |
| 886.1120 | Camera, Ophthalmic, General-Use | PJZ |
| 886.1250 | Euthyscope, AC-Powered | HMK |
| 886.1570 | Ophthalmoscope, AC-Powered | HLI |
| 886.1570 | Ophthalmoscope, Battery-Powered | HLJ |
| 886.1570 | Ophthalmoscopes, Replacement Batteries, Hand-Held | MSG |
| 886.1780 | Retinoscope, AC-Powered | HKL |
| 886.1945 | Transilluminator, AC-Powered | HJM |
| 886.4150 | Tubing, Replacement, Phacofragmentation Unit | MSR |
| 886.4250 | Unit, Electrolysis, AC-Powered, Ophthalmic | HRO |
| 886.4335 | Headlight, Fiberoptic Focusing | FCT |
| 886.4335 | Light, Headband, Surgical | FSR |
| 886.4335 | Headlamp, Operating, AC-Powered | HPQ |
| 886.4400 | Locator, Metal, Electronic | HPM |
| 886.4440 | Magnet, AC-Powered | HPO |
| 886.4790 | Sponge, Ophthalmic | HOZ |
| 886.4790 | Eye Tray | OJK |
| 888.1240 | Dynamometer, AC-Powered | LBB |
| 888.4580 | Instrument, Surgical, Sonic and Accessory/Attachment | JDX |
| 888.4580 | System, Cement Removal Extraction | LZV |
| 890.1450 | Hammer, Reflex, Powered | IKO |
| 890.5100 | Bath, Hydro-Massage | ILJ |
| 890.5100 | Bath, Sitz, Powered | ILM |
| 890.5110 | Bath, Paraffin | IMC |
| 890.5250 | Cabinet, Moist Steam | IMB |
| 890.5360 | Exerciser, Measuring | ISD |
| 890.5500 | Lamp, Infrared, Therapeutic Heating | ILY |
| 890.5575 | Device, Warning, Overload, External Limb, Powered | IRN |
| 892.1000 | MRI Disposable Kit | OIM |
| 892.1560 | Biopsy Needle Guide Kit | OIJ |
| 892.1610 | Aperature, Radiographic | IZS |
| 892.1610 | Cone, Radiographic | IZT |
| 892.1610 | Collimator, Automatic, Radiographic | IZW |
| 892.1610 | Collimator, Manual, Radiographic | IZX |
| 892.1610 | Device, Beam Limiting, X-Ray, Diagnostic | KPW |
| 892.1650 | Arthrogram Tray | OII |
| 892.1650 | Radiology Dental Tray | OIK |
| 892.1670 | Device, Spot-Film | IXL |
| 892.1680 | Radiographic Contrast Tray | OIO |
| 892.1680 | Radiology Diagnostic Kit | OIP |
| 892.1730 | Discography Kit | OIL |
| 892.1820 | Chair, Pneumocephalographic | HBK |
| 892.1850 | Cassette, Radiographic Film | IXA |
| 892.1860 | Changer, Radiographic Film/Cassette | KPX |
| 892.1870 | Programmer, Changer, Film/Cassette, Radiographic | IZP |
| 892.1900 | Controller, Temperature, Radiographic | EGT |
| 892.1900 | Dryer, Film, Radiographic | EGW |
| 892.1900 | Processor, Radiographic-Film, Automatic, Dental | EGY |
| 892.1900 | Processor, Radiographic-Film, Automatic | IXW |
| 892.1900 | Processor, Cine Film | IXX |
| 892.2030 | Digitizer, Image, Radiological | LMA |
| 892.2030 | Digitizer, Images, Ophthalmic | NFH |
| 892.2040 | Camera, Multi Format, Radiological | LMC |
| 892.2040 | Device, Hardcopy, Images, Ophthalmic | NFI |
| 892.5730 | Prostate Seeding Kit | OIN |

In table 2, FDA is identifying a list of class II devices that no longer require premarket notification under section 510(k) of the FD&C Act, subject to the general limitations to the exemptions found in §§ 862.9 to 892.9, as well as the indicated partial exemption limitations. Devices listed in table 2 are now exempt, but only if they are in concurrent compliance with both the partial exemption limitation specified in table 2 and its corresponding general limitation found in the .9 section of Parts 862 to 892 of Title 21 of the CFR.

| 21 CFR Section | Device type | Exempt | Former | Partial exemption limitation |
| --- | --- | --- | --- | --- |
| 862.3100 | Enzyme Immunoassay, Amphetamine | PUX | DKZ | Exemption is limited to test systems intended for employment and insurance testing that include a statement in their labeling that the device is intended solely for use in employment and insurance testing, and does not include test systems intended for Federal drug testing programs (
                            
                             programs run by the Substance Abuse and Mental Health Services Administration (SAMHSA), the Department of Transportation (DOT), and the U.S. military.) |
| 862.3100 | Radioimmunoassay, Amphetamine | PUX | DJP | Exemption is limited to test systems intended for employment and insurance testing that include a statement in their labeling that the device is intended solely for use in employment and insurance testing, and does not include test systems intended for Federal drug testing programs (
                            
                             programs run by the Substance Abuse and Mental Health Services Administration (SAMHSA), the Department of Transportation (DOT), and the U.S. military.) |
| 862.3100 | Thin Layer Chromatography, Amphetamine | PUX | DIT | Exemption is limited to test systems intended for employment and insurance testing that include a statement in their labeling that the device is intended solely for use in employment and insurance testing, and does not include test systems intended for Federal drug testing programs (
                            
                             programs run by the Substance Abuse and Mental Health Services Administration (SAMHSA), the Department of Transportation (DOT), and the U.S. military.) |
| 862.3100 | Gas Chromatography, Amphetamine | PUX | DOD | Exemption is limited to test systems intended for employment and insurance testing that include a statement in their labeling that the device is intended solely for use in employment and insurance testing, and does not include test systems intended for Federal drug testing programs (
                            
                             programs run by the Substance Abuse and Mental Health Services Administration (SAMHSA), the Department of Transportation (DOT), and the U.S. military.) |
| 862.3100 | Liquid Chromatography, Amphetamine | PUX | DNI | Exemption is limited to test systems intended for employment and insurance testing that include a statement in their labeling that the device is intended solely for use in employment and insurance testing, and does not include test systems intended for Federal drug testing programs (
                            
                             programs run by the Substance Abuse and Mental Health Services Administration (SAMHSA), the Department of Transportation (DOT), and the U.S. military.) |
| 862.3100 | Free Radical Assay, Amphetamine | PUX | DJL | Exemption is limited to test systems intended for employment and insurance testing that include a statement in their labeling that the device is intended solely for use in employment and insurance testing, and does not include test systems intended for Federal drug testing programs (
                            
                             programs run by the Substance Abuse and Mental Health Services Administration (SAMHSA), the Department of Transportation (DOT), and the U.S. military.) |
| 862.3150 | Enzyme Immunoassay, Barbiturate | PUY | DIS | Exemption is limited to test systems intended for employment and insurance testing that include a statement in their labeling that the device is intended solely for use in employment and insurance testing, and does not include test systems intended for Federal drug testing programs (
                            
                             programs run by the Substance Abuse and Mental Health Services Administration (SAMHSA), the Department of Transportation (DOT), and the U.S. military.) |
| 862.3150 | Radioimmunoassay, Barbiturate | PUY | DKN | Exemption is limited to test systems intended for employment and insurance testing that include a statement in their labeling that the device is intended solely for use in employment and insurance testing, and does not include test systems intended for Federal drug testing programs (
                            
                             programs run by the Substance Abuse and Mental Health Services Administration (SAMHSA), the Department of Transportation (DOT), and the U.S. military.) |
| 862.3150 | Thin Layer Chromatography, Barbiturate | PUY | DKX | Exemption is limited to test systems intended for employment and insurance testing that include a statement in their labeling that the device is intended solely for use in employment and insurance testing, and does not include test systems intended for Federal drug testing programs (
                            
                             programs run by the Substance Abuse and Mental Health Services Administration (SAMHSA), the Department of Transportation (DOT), and the U.S. military.) |
| 862.3150 | Mercury Dithiazone, Colorimetry, Barbiturate | PUY | DJN | Exemption is limited to test systems intended for employment and insurance testing that include a statement in their labeling that the device is intended solely for use in employment and insurance testing, and does not include test systems intended for Federal drug testing programs (
                            
                             programs run by the Substance Abuse and Mental Health Services Administration (SAMHSA), the Department of Transportation (DOT), and the U.S. military.) |
| 862.3150 | Hemagglutination Inhibition, Barbiturate | PUY | DLX | Exemption is limited to test systems intended for employment and insurance testing that include a statement in their labeling that the device is intended solely for use in employment and insurance testing, and does not include test systems intended for Federal drug testing programs (
                            
                             programs run by the Substance Abuse and Mental Health Services Administration (SAMHSA), the Department of Transportation (DOT), and the U.S. military.) |
| 862.3150 | Gas Liquid Chromatography, Barbiturate | PUY | DMF | Exemption is limited to test systems intended for employment and insurance testing that include a statement in their labeling that the device is intended solely for use in employment and insurance testing, and does not include test systems intended for Federal drug testing programs (
                            
                             programs run by the Substance Abuse and Mental Health Services Administration (SAMHSA), the Department of Transportation (DOT), and the U.S. military.) |
| 862.3150 | High Pressure Liquid Chromatography, Barbiturate | PUY | KZY | Exemption is limited to test systems intended for employment and insurance testing that include a statement in their labeling that the device is intended solely for use in employment and insurance testing, and does not include test systems intended for Federal drug testing programs (
                            
                             programs run by the Substance Abuse and Mental Health Services Administration (SAMHSA), the Department of Transportation (DOT), and the U.S. military.) |
| 862.3170 | Enzyme Immunoassay, Benzodiazepine | PUZ | JXM | Exemption is limited to test systems intended for employment and insurance testing that include a statement in their labeling that the device is intended solely for use in employment and insurance testing, and does not include test systems intended for Federal drug testing programs (
                            
                             programs run by the Substance Abuse and Mental Health Services Administration (SAMHSA), the Department of Transportation (DOT), and the U.S. military.) |
| 862.3170 | High Pressure Liquid Chromatography, Benzodiazepine | PUZ | LAA | Exemption is limited to test systems intended for employment and insurance testing that include a statement in their labeling that the device is intended solely for use in employment and insurance testing, and does not include test systems intended for Federal drug testing programs (
                            
                             programs run by the Substance Abuse and Mental Health Services Administration (SAMHSA), the Department of Transportation (DOT), and the U.S. military.) |
| 862.3170 | Test, Benzodiazepine, Over The Counter | PUZ | NFV | Exemption is limited to test systems intended for employment and insurance testing that include a statement in their labeling that the device is intended solely for use in employment and insurance testing, and does not include test systems intended for Federal drug testing programs (
                            
                             programs run by the Substance Abuse and Mental Health Services Administration (SAMHSA), the Department of Transportation (DOT), and the U.S. military.) |
| 862.3170 | Gas Chromatography, Benzodiazepine | PUZ | KZZ | Exemption is limited to test systems intended for employment and insurance testing that include a statement in their labeling that the device is intended solely for use in employment and insurance testing, and does not include test systems intended for Federal drug testing programs (
                            
                             programs run by the Substance Abuse and Mental Health Services Administration (SAMHSA), the Department of Transportation (DOT), and the U.S. military.) |
| 862.3170 | Thin Layer Chromatography, Benzodiazepine | PUZ | LAB | Exemption is limited to test systems intended for employment and insurance testing that include a statement in their labeling that the device is intended solely for use in employment and insurance testing, and does not include test systems intended for Federal drug testing programs (
                            
                             programs run by the Substance Abuse and Mental Health Services Administration (SAMHSA), the Department of Transportation (DOT), and the U.S. military.) |
| 862.3250 | Enzyme Immunoassay, Cocaine and Cocaine Metabolites | PVA | DIO | Exemption is limited to test systems intended for employment and insurance testing that include a statement in their labeling that the device is intended solely for use in employment and insurance testing, and does not include test systems intended for Federal drug testing programs (
                            
                             programs run by the Substance Abuse and Mental Health Services Administration (SAMHSA), the Department of Transportation (DOT), and the U.S. military.) |
| 862.3250 | Radioimmunoassay, Cocaine Metabolite | PVA | KLN | Exemption is limited to test systems intended for employment and insurance testing that include a statement in their labeling that the device is intended solely for use in employment and insurance testing, and does not include test systems intended for Federal drug testing programs (
                            
                             programs run by the Substance Abuse and Mental Health Services Administration (SAMHSA), the Department of Transportation (DOT), and the U.S. military.) |
| 862.3250 | Enzyme Immunoassay, Cocaine | PVA | JXO | Exemption is limited to test systems intended for employment and insurance testing that include a statement in their labeling that the device is intended solely for use in employment and insurance testing, and does not include test systems intended for Federal drug testing programs (
                            
                             programs run by the Substance Abuse and Mental Health Services Administration (SAMHSA), the Department of Transportation (DOT), and the U.S. military.) |
| 862.3250 | Hemagglutination, Cocaine Metabolites (Benzoylecgonine) | PVA | DLN | Exemption is limited to test systems intended for employment and insurance testing that include a statement in their labeling that the device is intended solely for use in employment and insurance testing, and does not include test systems intended for Federal drug testing programs (
                            
                             programs run by the Substance Abuse and Mental Health Services Administration (SAMHSA), the Department of Transportation (DOT), and the U.S. military.) |
| 862.3250 | Thin Layer Chromatography, Cocaine | PVA | DMN | Exemption is limited to test systems intended for employment and insurance testing that include a statement in their labeling that the device is intended solely for use in employment and insurance testing, and does not include test systems intended for Federal drug testing programs (
                            
                             programs run by the Substance Abuse and Mental Health Services Administration (SAMHSA), the Department of Transportation (DOT), and the U.S. military.) |
| 862.3250 | Free Radical Assay, Cocaine | PVA | DIR | Exemption is limited to test systems intended for employment and insurance testing that include a statement in their labeling that the device is intended solely for use in employment and insurance testing, and does not include test systems intended for Federal drug testing programs (
                            
                             programs run by the Substance Abuse and Mental Health Services Administration (SAMHSA), the Department of Transportation (DOT), and the U.S. military.) |
| 862.3250 | Gas Chromatography, Cocaine | PVA | DIN | Exemption is limited to test systems intended for employment and insurance testing that include a statement in their labeling that the device is intended solely for use in employment and insurance testing, and does not include test systems intended for Federal drug testing programs (
                            
                             programs run by the Substance Abuse and Mental Health Services Administration (SAMHSA), the Department of Transportation (DOT), and the U.S. military.) |
| 862.3250 | Thin Layer Chromatography, Benzoylecgonine | PVA | DOM | Exemption is limited to test systems intended for employment and insurance testing that include a statement in their labeling that the device is intended solely for use in employment and insurance testing, and does not include test systems intended for Federal drug testing programs (
                            
                             programs run by the Substance Abuse and Mental Health Services Administration (SAMHSA), the Department of Transportation (DOT), and the U.S. military.) |
| 862.3250 | High Pressure Liquid Chromatography, Cocaine and Cocaine Metabolites | PVA | LAC | Exemption is limited to test systems intended for employment and insurance testing that include a statement in their labeling that the device is intended solely for use in employment and insurance testing, and does not include test systems intended for Federal drug testing programs (
                            
                             programs run by the Substance Abuse and Mental Health Services Administration (SAMHSA), the Department of Transportation (DOT), and the U.S. military.) |
| 862.3270 | High Pressure Liquid Chromatography, Codeine | PVB | LAE | Exemption is limited to test systems intended for employment and insurance testing that include a statement in their labeling that the device is intended solely for use in employment and insurance testing, and does not include test systems intended for Federal drug testing programs (
                            
                             programs run by the Substance Abuse and Mental Health Services Administration (SAMHSA), the Department of Transportation (DOT), and the U.S. military.) |
| 862.3270 | Thin Layer Chromatography, Codeine | PVB | DLD | Exemption is limited to test systems intended for employment and insurance testing that include a statement in their labeling that the device is intended solely for use in employment and insurance testing, and does not include test systems intended for Federal drug testing programs (
                            
                             programs run by the Substance Abuse and Mental Health Services Administration (SAMHSA), the Department of Transportation (DOT), and the U.S. military.) |
| 862.3270 | Gas Chromatography, Codeine | PVB | LAD | Exemption is limited to test systems intended for employment and insurance testing that include a statement in their labeling that the device is intended solely for use in employment and insurance testing, and does not include test systems intended for Federal drug testing programs (
                            
                             programs run by the Substance Abuse and Mental Health Services Administration (SAMHSA), the Department of Transportation (DOT), and the U.S. military.) |
| 862.3580 | Radioimmunoassay, LSD (125-I) | PVC | DLB | Exemption is limited to test systems intended for employment and insurance testing that include a statement in their labeling that the device is intended solely for use in employment and insurance testing, and does not include test systems intended for Federal drug testing programs (
                            
                             programs run by the Substance Abuse and Mental Health Services Administration (SAMHSA), the Department of Transportation (DOT), and the U.S. military.) |
| 862.3580 | Free Radical Assay, LSD | PVC | DOL | Exemption is limited to test systems intended for employment and insurance testing that include a statement in their labeling that the device is intended solely for use in employment and insurance testing, and does not include test systems intended for Federal drug testing programs (
                            
                             programs run by the Substance Abuse and Mental Health Services Administration (SAMHSA), the Department of Transportation (DOT), and the U.S. military.) |
| 862.3610 | Gas Chromatography, Methamphetamine | PVD | LAF | Exemption is limited to test systems intended for employment and insurance testing that include a statement in their labeling that the device is intended solely for use in employment and insurance testing, and does not include test systems intended for Federal drug testing programs (
                            
                             programs run by the Substance Abuse and Mental Health Services Administration (SAMHSA), the Department of Transportation (DOT), and the U.S. military.) |
| 862.3610 | Thin Layer Chromatography, Methamphetamine | PVD | DJC | Exemption is limited to test systems intended for employment and insurance testing that include a statement in their labeling that the device is intended solely for use in employment and insurance testing, and does not include test systems intended for Federal drug testing programs (
                            
                             programs run by the Substance Abuse and Mental Health Services Administration (SAMHSA), the Department of Transportation (DOT), and the U.S. military.) |
| 862.3610 | High Pressure Liquid Chromatography, Methamphetamine | PVD | LAG | Exemption is limited to test systems intended for employment and insurance testing that include a statement in their labeling that the device is intended solely for use in employment and insurance testing, and does not include test systems intended for Federal drug testing programs (
                            
                             programs run by the Substance Abuse and Mental Health Services Administration (SAMHSA), the Department of Transportation (DOT), and the U.S. military.) |
| 862.3610 | Test, Methamphetamine, Over The Counter | PVD | NGG | Exemption is limited to test systems intended for employment and insurance testing that include a statement in their labeling that the device is intended solely for use in employment and insurance testing, and does not include test systems intended for Federal drug testing programs (
                            
                             programs run by the Substance Abuse and Mental Health Services Administration (SAMHSA), the Department of Transportation (DOT), and the U.S. military.) |
| 862.3620 | Enzyme Immunoassay, Methadone | PVE | DJR | Exemption is limited to test systems intended for employment and insurance testing that include a statement in their labeling that the device is intended solely for use in employment and insurance testing, and does not include test systems intended for Federal drug testing programs (
                            
                             programs run by the Substance Abuse and Mental Health Services Administration (SAMHSA), the Department of Transportation (DOT), and the U.S. military.) |
| 862.3620 | Hemagglutination Inhibition, Methadone | PVE | DIW | Exemption is limited to test systems intended for employment and insurance testing that include a statement in their labeling that the device is intended solely for use in employment and insurance testing, and does not include test systems intended for Federal drug testing programs (
                            
                             programs run by the Substance Abuse and Mental Health Services Administration (SAMHSA), the Department of Transportation (DOT), and the U.S. military.) |
| 862.3620 | Gas Chromatography, Methadone | PVE | DMB | Exemption is limited to test systems intended for employment and insurance testing that include a statement in their labeling that the device is intended solely for use in employment and insurance testing, and does not include test systems intended for Federal drug testing programs (
                            
                             programs run by the Substance Abuse and Mental Health Services Administration (SAMHSA), the Department of Transportation (DOT), and the U.S. military.) |
| 862.3620 | Thin Layer Chromatography, Methadone | PVE | DKR | Exemption is limited to test systems intended for employment and insurance testing that include a statement in their labeling that the device is intended solely for use in employment and insurance testing, and does not include test systems intended for Federal drug testing programs (
                            
                             programs run by the Substance Abuse and Mental Health Services Administration (SAMHSA), the Department of Transportation (DOT), and the U.S. military.) |
| 862.3620 | Liquid Chromatography, Methadone | PVE | DNT | Exemption is limited to test systems intended for employment and insurance testing that include a statement in their labeling that the device is intended solely for use in employment and insurance testing, and does not include test systems intended for Federal drug testing programs (
                            
                             programs run by the Substance Abuse and Mental Health Services Administration (SAMHSA), the Department of Transportation (DOT), and the U.S. military.) |
| 862.3620 | Free Radical Assay, Methadone | PVE | DPP | Exemption is limited to test systems intended for employment and insurance testing that include a statement in their labeling that the device is intended solely for use in employment and insurance testing, and does not include test systems intended for Federal drug testing programs (
                            
                             programs run by the Substance Abuse and Mental Health Services Administration (SAMHSA), the Department of Transportation (DOT), and the U.S. military.) |
| 862.3630 | Radioimmunoassay, Methaqualone | PVF | KXS | Exemption is limited to test systems intended for employment and insurance testing that include a statement in their labeling that the device is intended solely for use in employment and insurance testing, and does not include test systems intended for Federal drug testing programs (
                            
                             programs run by the Substance Abuse and Mental Health Services Administration (SAMHSA), the Department of Transportation (DOT), and the U.S. military.) |
| 862.3640 | Thin Layer Chromatography, Morphine | PVG | DNK | Exemption is limited to test systems intended for employment and insurance testing that include a statement in their labeling that the device is intended solely for use in employment and insurance testing, and does not include test systems intended for Federal drug testing programs (
                            
                             programs run by the Substance Abuse and Mental Health Services Administration (SAMHSA), the Department of Transportation (DOT), and the U.S. military.) |
| 862.3640 | Radioimmunoassay, Morphine (123-I), Goat Antibody Ammonium Sulfate Sep. | PVG | DOE | Exemption is limited to test systems intended for employment and insurance testing that include a statement in their labeling that the device is intended solely for use in employment and insurance testing, and does not include test systems intended for Federal drug testing programs (
                            
                             programs run by the Substance Abuse and Mental Health Services Administration (SAMHSA), the Department of Transportation (DOT), and the U.S. military.) |
| 862.3640 | Fluorometry, Morphine | PVG | DJJ | Exemption is limited to test systems intended for employment and insurance testing that include a statement in their labeling that the device is intended solely for use in employment and insurance testing, and does not include test systems intended for Federal drug testing programs (
                            
                             programs run by the Substance Abuse and Mental Health Services Administration (SAMHSA), the Department of Transportation (DOT), and the U.S. military.) |
| 862.3640 | Liquid Chromatography, Morphine | PVG | DPK | Exemption is limited to test systems intended for employment and insurance testing that include a statement in their labeling that the device is intended solely for use in employment and insurance testing, and does not include test systems intended for Federal drug testing programs (
                            
                             programs run by the Substance Abuse and Mental Health Services Administration (SAMHSA), the Department of Transportation (DOT), and the U.S. military.) |
| 862.3640 | Gas Chromatography, Morphine | PVG | DMY | Exemption is limited to test systems intended for employment and insurance testing that include a statement in their labeling that the device is intended solely for use in employment and insurance testing, and does not include test systems intended for Federal drug testing programs (
                            
                             programs run by the Substance Abuse and Mental Health Services Administration (SAMHSA), the Department of Transportation (DOT), and the U.S. military.) |
| 862.3640 | Hemagglutination Inhibition, Morphine | PVG | DLR | Exemption is limited to test systems intended for employment and insurance testing that include a statement in their labeling that the device is intended solely for use in employment and insurance testing, and does not include test systems intended for Federal drug testing programs (
                            
                             programs run by the Substance Abuse and Mental Health Services Administration (SAMHSA), the Department of Transportation (DOT), and the U.S. military.) |
| 862.3640 | Free Radical Assay, Morphine | PVG | DOK | Exemption is limited to test systems intended for employment and insurance testing that include a statement in their labeling that the device is intended solely for use in employment and insurance testing, and does not include test systems intended for Federal drug testing programs (
                            
                             programs run by the Substance Abuse and Mental Health Services Administration (SAMHSA), the Department of Transportation (DOT), and the U.S. military.) |
| 862.3640 | Radioimmunoassay, Morphine (3-H), Goat Antibody Ammonium Sulfate Sep. | PVG | DIQ | Exemption is limited to test systems intended for employment and insurance testing that include a statement in their labeling that the device is intended solely for use in employment and insurance testing, and does not include test systems intended for Federal drug testing programs (
                            
                             programs run by the Substance Abuse and Mental Health Services Administration (SAMHSA), the Department of Transportation (DOT), and the U.S. military.) |
| 862.3640 | Radioimmunoassay, Morphine-Barbiturate (125-I), Goat Antibody | PVG | DNA | Exemption is limited to test systems intended for employment and insurance testing that include a statement in their labeling that the device is intended solely for use in employment and insurance testing, and does not include test systems intended for Federal drug testing programs (
                            
                             programs run by the Substance Abuse and Mental Health Services Administration (SAMHSA), the Department of Transportation (DOT), and the U.S. military.) |
| 862.3650 | Enzyme Immunoassay, Opiates | PVH | DJG | Exemption is limited to test systems intended for employment and insurance testing that include a statement in their labeling that the device is intended solely for use in employment and insurance testing, and does not include test systems intended for Federal drug testing programs (
                            
                             programs run by the Substance Abuse and Mental Health Services Administration (SAMHSA), the Department of Transportation (DOT), and the U.S. military.) |
| 862.3650 | Gas Chromatography, Opiates | PVH | DJF | Exemption is limited to test systems intended for employment and insurance testing that include a statement in their labeling that the device is intended solely for use in employment and insurance testing, and does not include test systems intended for Federal drug testing programs (
                            
                             programs run by the Substance Abuse and Mental Health Services Administration (SAMHSA), the Department of Transportation (DOT), and the U.S. military.) |
| 862.3650 | Hemagglutination, Opiates | PVH | DLT | Exemption is limited to test systems intended for employment and insurance testing that include a statement in their labeling that the device is intended solely for use in employment and insurance testing, and does not include test systems intended for Federal drug testing programs (
                            
                             programs run by the Substance Abuse and Mental Health Services Administration (SAMHSA), the Department of Transportation (DOT), and the U.S. military.) |
| 862.3650 | Thin Layer Chromatography, Opiates | PVH | LAI | Exemption is limited to test systems intended for employment and insurance testing that include a statement in their labeling that the device is intended solely for use in employment and insurance testing, and does not include test systems intended for Federal drug testing programs (
                            
                             programs run by the Substance Abuse and Mental Health Services Administration (SAMHSA), the Department of Transportation (DOT), and the U.S. military.) |
| 862.3650 | Free Radical Assay, Opiates | PVH | DKT | Exemption is limited to test systems intended for employment and insurance testing that include a statement in their labeling that the device is intended solely for use in employment and insurance testing, and does not include test systems intended for Federal drug testing programs (
                            
                             programs run by the Substance Abuse and Mental Health Services Administration (SAMHSA), the Department of Transportation (DOT), and the U.S. military.) |
| 862.3650 | High Pressure Liquid Chromatography, Opiates | PVH | LAH | Exemption is limited to test systems intended for employment and insurance testing that include a statement in their labeling that the device is intended solely for use in employment and insurance testing, and does not include test systems intended for Federal drug testing programs (
                            
                             programs run by the Substance Abuse and Mental Health Services Administration (SAMHSA), the Department of Transportation (DOT), and the U.S. military.) |
| 862.3700 | Enzyme Immunoassay, Propoxyphene | PVI | JXN | Exemption is limited to test systems intended for employment and insurance testing that include a statement in their labeling that the device is intended solely for use in employment and insurance testing, and does not include test systems intended for Federal drug testing programs (
                            
                             programs run by the Substance Abuse and Mental Health Services Administration (SAMHSA), the Department of Transportation (DOT), and the U.S. military.) |
| 862.3700 | Thin Layer Chromatography, Propoxyphene | PVI | DPN | Exemption is limited to test systems intended for employment and insurance testing that include a statement in their labeling that the device is intended solely for use in employment and insurance testing, and does not include test systems intended for Federal drug testing programs (
                            
                             programs run by the Substance Abuse and Mental Health Services Administration (SAMHSA), the Department of Transportation (DOT), and the U.S. military.) |
| 862.3700 | Gas Chromatography, Propoxyphene | PVI | LAJ | Exemption is limited to test systems intended for employment and insurance testing that include a statement in their labeling that the device is intended solely for use in employment and insurance testing, and does not include test systems intended for Federal drug testing programs (
                            
                             programs run by the Substance Abuse and Mental Health Services Administration (SAMHSA), the Department of Transportation (DOT), and the U.S. military.) |
| 862.3700 | High Pressure Liquid Chromatography, Propoxyphene | PVI | LAK | Exemption is limited to test systems intended for employment and insurance testing that include a statement in their labeling that the device is intended solely for use in employment and insurance testing, and does not include test systems intended for Federal drug testing programs (
                            
                             programs run by the Substance Abuse and Mental Health Services Administration (SAMHSA), the Department of Transportation (DOT), and the U.S. military.) |
| 862.3870 | Enzyme Immunoassay, Cannabinoids | PVJ | LDJ | Exemption is limited to test systems intended for employment and insurance testing that include a statement in their labeling that the device is intended solely for use in employment and insurance testing, and does not include test systems intended for Federal drug testing programs (
                            
                             programs run by the Substance Abuse and Mental Health Services Administration (SAMHSA), the Department of Transportation (DOT), and the U.S. military.) |
| 862.3870 | Reagents, Test, Tetrahydrocannabinol | PVJ | DKE | Exemption is limited to test systems intended for employment and insurance testing that include a statement in their labeling that the device is intended solely for use in employment and insurance testing, and does not include test systems intended for Federal drug testing programs (
                            
                             programs run by the Substance Abuse and Mental Health Services Administration (SAMHSA), the Department of Transportation (DOT), and the U.S. military.) |
| 862.3870 | Radioimmunoassay, Cannabinoid(S) | PVJ | LAT | Exemption is limited to test systems intended for employment and insurance testing that include a statement in their labeling that the device is intended solely for use in employment and insurance testing, and does not include test systems intended for Federal drug testing programs (
                            
                             programs run by the Substance Abuse and Mental Health Services Administration (SAMHSA), the Department of Transportation (DOT), and the U.S. military.) |
| 862.3910 | High Pressure Liquid Chromatography, Tricyclic Antidepressant Drugs | PVK | LFI | Exemption is limited to test systems intended for employment and insurance testing that include a statement in their labeling that the device is intended solely for use in employment and insurance testing, and does not include test systems intended for Federal drug testing programs (
                            
                             programs run by the Substance Abuse and Mental Health Services Administration (SAMHSA), the Department of Transportation (DOT), and the U.S. military.) |
| 862.3910 | U.V. Spectrometry, Tricyclic Antidepressant Drugs | PVK | LFH | Exemption is limited to test systems intended for employment and insurance testing that include a statement in their labeling that the device is intended solely for use in employment and insurance testing, and does not include test systems intended for Federal drug testing programs (
                            
                             programs run by the Substance Abuse and Mental Health Services Administration (SAMHSA), the Department of Transportation (DOT), and the U.S. military.) |
| 862.3910 | Thin Layer Chromatography, Tricyclic Antidepressant Drugs | PVK | MLK | Exemption is limited to test systems intended for employment and insurance testing that include a statement in their labeling that the device is intended solely for use in employment and insurance testing, and does not include test systems intended for Federal drug testing programs (
                            
                             programs run by the Substance Abuse and Mental Health Services Administration (SAMHSA), the Department of Transportation (DOT), and the U.S. military.) |
| 866.5750 | System, Test, Radioallergosorbent (RAST) Immunological | PUW | DHB | Exemption is limited to devices classified under 21 CFR 866.5750 that are intended to detect any of the allergens included in table 3 of this document. |
| 868.2385 | Analyzer, Nitrogen Dioxide | PUG | MRQ | Exemption is limited to standalone nitrogen dioxide analyzers and not those that are components of nitric oxide delivery systems intended to monitor nitrogen dioxide levels during inhaled nitric oxide therapy. |
| 870.1330 | Wire, Guide, Catheter | PTL | DQX | Exemption is limited to accessory torque devices that are manually operated, non-patient contacting, and intended to manipulate non-cerebral vascular guide wires. |
| 870.1650 | Syringe, Balloon Inflation | PTM | MAV | Exemption is limited to non-patient contacting balloon inflation syringes intended only to inflate/deflate balloon catheters and monitor pressure within the balloon. |
| 870.2770 | Analyzer, Body Composition | PUH | MNW | Exemption is limited to body composition analyzers which are not intended to diagnose or treat any medical condition. |
| 870.4400 | Reservoir, Blood, Cardiopulmonary Bypass | PTN | DTN | Exemption is limited to cardiopulmonary bypass blood reservoirs that do not contain defoamers or blood filters. |
| 874.1090 | Tester, Auditory Impedance | PTO | ETY | Exemption is limited to auditory impedance testers that are in compliance with FDA-recognized consensus standard ANSI S3.39. |
| 874.1090 | Tympanometer | PTP | NAS | Exemption is limited to tympanometers that are in compliance with FDA-recognized consensus standard ANSI S3.39. |
| 876.1500 | Endoscopic Magnetic Retriever | PTQ | FCC | Exemption is limited to endoscopic magnetic retrievers intended for single use. |
| 876.1500 | Scissors For Cystoscope | PTR | KGD | Exemption is limited to sterile scissors for cystoscope intended for single use. |
| 876.1500 | Endoscopic Grasping/Cutting Instrument, Non-Powered | PTS | OCZ | Exemption is limited to disposable, non-powered endoscopic grasping/cutting instruments intended for single use. |
| 876.5010 | Catheter, Biliary, Surgical | PTT | GCA | Exemption is limited to surgical biliary catheters that do not include a balloon component. |
| 876.5630 | Catheter, Peritoneal, Long-Term Indwelling | PTU | FJS | Exemption is limited to non-patient contacting catheter finger grips intended for single use. |
| 876.5630 | Catheter, Peritoneal Dialysis, Single Use | PTV | FKO | Exemption is limited to non-patient contacting catheter finger grips intended for single use. |
| 876.5630 | System, Peritoneal, Automatic Delivery | PTW | FKX | Exemption is limited to continuous ambulatory peritoneal dialysis (CAPD) belts and catheter stands that do not include weigh scales. |
| 878.4370 | Drape, Surgical | PUI | KKX | Exemption is limited to surgical drapes that do not include an antimicrobial agent. |
| 878.4495 | Suture, Nonabsorbable, Steel, Monofilament And Multifilament, Sterile | PTX | GAQ | Exemption is limited to steel monofilament sutures that are uncoated and do not incorporate barbs. |
| 882.1470 | Computerized Cognitive Assessment Aid | PTY | PKQ | Exemption is limited to computerized cognitive assessment aids that are not intended for diagnostic assessment of specific diseases or conditions and rely on inputs from visual cues, auditory cues, and/or functional use of the hand. |
| 884.1630 | Colposcope (and Colpomicroscope) | PTZ | HEX | Exemption is limited to standard colposcopes (and colpomicroscopes) that use only a white light source, do not use filters other than a green filter, do not include image analysis software, and are not smartphone-based. |
| 884.4530 | Tenaculum, Uterine | PUA | HDC | Exemption is limited to sterile uterine tenaculum devices that do not use suction and are intended for single use. |
| 884.6120 | Accessory, Assisted Reproduction | PUB | MQG | Exemption is limited to simple embryo incubators with temperature, gas, and humidity control only; syringe pumps; collection tube warmers; dish/plate/microscope stage warmers; and controlled-rate cryopreservation freezers. |
| 884.6130 | Microtools, Assisted Reproduction (Pipettes) | PUC | MQH | Exemption is limited to assisted reproduction microtools (pipettes) manufactured from glass. |
| 884.6160 | Labware, Assisted Reproduction | PUD | MQK | Exemption is limited to dishes and plates that are intended for general assisted reproduction technology procedures. |
| 886.1850 | Biomicroscope, Slit-Lamp, AC-Powered | PUE | HJO | Exemption is limited to slit-lamp, AC-powered biomicroscopes intended only for the visual examination of the anterior segment of the eye, are classified as Group 1 per FDA-recognized consensus standard ANSI Z80.36, do not provide any quantitative output, and are not intended for screening or automated diagnostic indications. |
| 886.3320 | Ocular Peg | PUF | MQU | Exemption is limited to ocular pegs supplied sterile. |

In table 2, FDA included devices classified under § 866.5750 (Radioallergosorbent (RAST) immunological test system). FDA does not believe that all devices classified under this regulation meet the exemption criteria from premarket notification requirements. The devices listed in table 3 are also classified under § 866.5750, but this subset no longer requires premarket notification under section 510(k) of the FD&C Act, subject to the general limitations to the exemptions found in § 866.9. While the non-exempt devices classified under § 866.5750 will retain product code “DHB”, these devices listed in table 3 are reassigned product code “PUW.”

| Allergen code | Allergen product | Source |
| --- | --- | --- |
|  |  |  |
| g1 | Sweet vernal grass |  |
| g3 | Cocksfoot grass, Orchard grass |  |
| g4 | Meadow fescue |  |
| g5 | Rye-grass (perennial rye grass) |  |
| g7 | Common reed (common reed grass) |  |
| g8 | Meadow grass, Kentucky blue (June grass) |  |
| g9 | Redtop, Bentgrass |  |
| g11 | Brome grass |  |
| g12 | Cultivated rye (cultivated rye grass) |  |
| g13 | Velvet grass |  |
| g14 | Cultivated oat (cultivated oat grass) |  |
| g15 | Cultivated wheat (cultivated wheat grass) |  |
| g16 | Meadow foxtail (meadow foxtail grass) |  |
| g17 | Bahia grass |  |
| g24 | Wheat grass, Western |  |
| g30 | Bluegrass, annual |  |
| g70 | Wild rye grass |  |
| g71 | Canary grass |  |
| g201 | Barley, cultivated |  |
| g202 | Maize, corn (cultivated corn) |  |
| g203 | Salt grass |  |
| g204 | False oat-grass |  |
| g216 | Cyn d 1 |  |
| g701 | Phl p 1.0102, Phl p 5.0101 |  |
| g702 | Phl p 7.0101 |  |
| g703 | Phl p 12.0101 |  |
|  |  |  |
| w2 | Western ragweed |  |
| w4 | False ragweed |  |
| w5 | Wormwood |  |
| w6 | Mugwort |  |
| w7 | Marguerite, ox-eye daisy |  |
| w8 | Dandelion |  |
| w9 | Plantain (English), Ribwort |  |
| w10 | Goosefoot, lamb's quarters |  |
| w11 | Saltwort (prickly), Russian thistle |  |
| w12 | Goldenrod |  |
| w13 | Cocklebur, common |  |
| w14 | Common pigweed (rough pigweed) |  |
| w15 | Scale, Lenscale |  |
| w16 | Rough marsh elder |  |
| w17 | Firebush (Kochia) |  |
| w18 | Sheep sorrel |  |
| w19 | Wall pellitory |  |
| w20 | Nettle (Common stinging nettle) |  |
| w21 | Wall pellitory |  |
| w22 | Japanese hop (careless weed) |  |
| w23 | Yellow dock, Yellow dockweed |  |
| w24 | Spiny pigweed |  |
| w27 | Carnation | spp. |
| w28 | Rose |  |
| w33 | Clover |  |
| w35 | Mexican tea |  |
| w36 | Rabbit bush |  |
| w37 | Salt bush, annual |  |
| w39 | Water hemp, Western |  |
| w41 | Burrobrush |  |
| w42 | Poverty weed |  |
| w43 | Common sagebrush |  |
| w45 | Alfalfa |  |
| w46 | Dog fennel |  |
| w53 | Geranium | spp. |
| w67 | Groundsel bush |  |
| w69 | Iodine bush |  |
| w70 | Ragweed, slender |  |
| w75 | Wing scale (wingscale) |  |
| w82 | Careless weed |  |
| w90 | Japanese hop |  |
| w203 | Rape (rape pollen) |  |
| w204 | Sunflower |  |
| w206 | Camomile |  |
| w207 | Lupin | spp. |
| w210 | Sugar-beet |  |
| w211 | Par j 2.0101 |  |
| w231 | Art v 1 | (Mugwort). |
| w232 | Sal k 1 |  |
| w233 | Art v 3 | (LTP, Mugwort). |
| w234 | Pla l 1 |  |
| w235 | Che a 1.0101 |  |
| w236 | Mer a 1.0101 |  |
| a753 | Art v 1 | (Mugwort weed). |
|  |  |  |
| t1 | Box-elder (Maple) |  |
| t2 | Gray alder, speckled alder (alder) |  |
| t4 | Hazel, hazelnut |  |
| t5 | American beech (beech) |  |
| t6 | Mountain juniper, Mountain cedar |  |
| t8 | Elm |  |
| t9 | Olive |  |
| t10 | Walnut |  |
| t11 | Maple leaf sycamore, London plane, Plane tree |  |
| t61 | Sycamore |  |
| t12 | Willow |  |
| t14 | Cottonwood (Eastern Cottonwood/Black Cottonwood) |  |
| t15 | White ash |  |
| t16 | White pine |  |
| t18 | Eucalyptus, gum-tree |  |
| t19/t26 | Acacia | (
                            
                             spp.). |
| t20 | Mesquite |  |
| t21 | Melaleuca, cajeput tree | (
                            
                            ). |
| t22 | Pecan, hickory |  |
| t23 | Italian/Mediterranean/funeral cypress |  |
| t24 | Japanese cypress | (
                            
                             spp.). |
| t25 | Ash |  |
| t27 | Maple, red |  |
| t29 | Acacia | spp. |
| t30 | Birch, white |  |
| t32 | Willow, black |  |
| t33 | Ash, Arizona |  |
| t35 | Cedar, salt |  |
| t37 | Bald cypress (white bald cypress) |  |
| t38 | Elm, Chinese/Siberian |  |
| t40 | Hazelnut tree |  |
| t41 | White hickory |  |
| t42 | Oak, red |  |
| t43 | Loblolly pine |  |
| t44 | Hackberry |  |
| t45 | Cedar elm |  |
| t47 | Juniper, one seed |  |
| t48 | Pine, lodgepole |  |
| t49 | Pine, ponderosa |  |
| t50 | Beech, European |  |
| t51 | Tree of Heaven |  |
| t52 | Western white pine |  |
| t54 | Russian olive |  |
| t55 | Scotch broom |  |
| t56 | Bayberry |  |
| t57 | Red cedar |  |
| t60 | Western juniper |  |
| t61 | Sycamore |  |
| t70 | Mulberry (white mulberry) |  |
| t71 | Red mulberry |  |
| t72 | Queen palm |  |
| t73 | Australian pine |  |
| t77 | Oak mix (red, white, black) | spp. |
| t80 | Japanese cypress |  |
| t81 | Japanese alder |  |
| t83 | Mango tree |  |
| t90 | Walnut, black |  |
| t96 | Poplar, white (poplar) |  |
| t103/ | Virginia live oak (live oak) |  |
| t105 | Pepper tree |  |
| t110 | Orange tree |  |
| t201 | Spruce, Norway spruce | (
                            
                            ). |
| t202 | Alder, smooth | spp. |
| t203 | Horse chestnut |  |
| t205 | Elder |  |
| t206 | Chestnut |  |
| t207 | Douglas fir | (
                            
                            ). |
| t208 | Linden |  |
| t209 | Horn beam |  |
| t210 | Privet |  |
| t211 | Sweet gum |  |
| t212 | Cedar |  |
| t213 | Pine |  |
| t214 | Date palm |  |
| t215 | Lilac |  |
| t217 | Pepper tree |  |
| t217 | Red alder |  |
| t218 | Virginia live oak |  |
| t218 | Bayberry (bayberry/sweet gale) |  |
| t219 | Palo verde |  |
| t219 | Red cedar |  |
| t220 | Bet v 4 | (Birch). |
| t221 | Bet v 2.0101, Bet v 4 | (Birch). |
| t222 | Cypress (Arizona cypress) |  |
| t223 | Oil palm |  |
| t224 | Ole e 1 |  |
| t225 | Bet v 6 | (Birch). |
| t226 | Cup a 1 |  |
| t227 | Ole e 7 |  |
| t228 | Aspen, quaking |  |
| t229 | Eastern hemlock |  |
| t230 | Redwood (sequoia) |  |
| t232 | Pussy willow |  |
| t240 | Ole e 9.0101 |  |
| t241 | Pla a 1.0101 |  |
| t242 | Pla a 2 |  |
| t243 | Pla a 3.0101 |  |
| t244 | Cor a 1.0103 |  |
| t245 | Aln g 1.0101 |  |
| t246 | Cry j 1 |  |
| t280 | Locust tree |  |
| t401 | Brazilian peppertree |  |
| t402 | Mastic tree |  |
| t404 | Tree of heaven |  |
| t406 | Date palm |  |
| a482 | Ole e 1 | (Olive Oil). |
|  |  |  |
| d207 | Blo t 5.0101 |  |
| d208 | Lep d 2.0101 |  |
|  |  |  |
| m1 |  | (
                            
                            ). |
| m2 | (
                            
                            ) | (
                            
                            ). |
| m3 |  | . |
| m4 |  | . |
| m5 |  | . |
| m7 |  | . |
| m8 | (
                            
                            ) |  |
| m9 | (
                            
                            ) |  |
| m10 |  |  |
| m11 |  | . |
| m12 |  | . |
| m13 |  | . |
| m14 |  |  |
| m15 |  | . |
| m16 |  |  |
| m17 |  | . |
| m18 |  | . |
| m19 |  | . |
| m20 |  | . |
| m21 |  | . |
| m22 |  | (
                            
                            ). |
| m23 |  | . |
| m24 |  | (
                            
                            ). |
| m24 | spp. | spp. |
| m25 |  | . |
| m25 |  | . |
| m26 |  | . |
| m26 |  | . |
| m27 | spp. | spp. |
| m29 |  | . |
| m30 |  | . |
| m32 |  | . |
| m34 |  | . |
| m36 |  | . |
| m37 |  | . |
| m40 |  | . |
| m43 |  | . |
| m44 |  | . |
| m45 |  | . |
| m46 |  | . |
| m47 |  | . |
| m48 |  | . |
| m49 |  | . |
| m50 |  | (
                            
                            ). |
| m51 |  | . |
| m53 |  |  |
| m54 |  | . |
| m63 |  | . |
| m66 |  | . |
| m67 |  | . |
| m68 |  | . |
| m69 |  |  |
| m70 | (
                            
                            ) |  |
| m71 |  | spp. |
| m72 |  | . |
| m73 |  |  |
| m80 | (
                            
                            ) | . |
| m80 | spp. | spp. |
| m81 | (
                            
                            ) | . |
| m88 |  | . |
| m93 |  | . |
| m94 |  | . |
| m201 | (
                            
                            ) (Barley smut) |  |
| m202 | (
                            
                            ) | (
                            
                            ). |
| m203 |  | . |
| m204 |  | . |
| m205 |  | . |
| m207 |  | . |
| m208 |  | . |
| m209 |  |  |
| m209 |  | (
                            
                            ). |
| m210 |  | . |
| m211 |  | . |
| m211 | Oat smut | . |
| m212 |  | (
                            
                            ). |
| m212 |  | . |
| m213 | Bermuda grass smut | . |
| m214 | Johnson grass smut | . |
| m215 | Corn smut | . |
| m218 | Asp f 1.0101 | . |
| a3050 | Asp r 1 | . |
| m219 | Asp f 2 | . |
| m220 | Asp f 3.0101 | . |
| m221 | Asp f 4 | . |
| m222 | Asp f 6.0101 | . |
| m223 | (
                            
                            ) | . |
| m224 | (
                            
                            ) | . |
| m226 | (
                            
                            ) | . |
| m227 | spp. (
                            
                             spp.) | spp. (
                            
                             spp.). |
| m228 | . |  |
| m229 | Alt a 1.0101 | (
                            
                            ). |
| m230 | Alt a 6.0101 | (
                            
                            ). |
| m231 | Cla h 8.0101 | (
                            
                            ). |
| m300 | spp. | spp. |
| m304 |  | . |
| m305 |  | . |
| m309 |  | . |
| m310 |  | . |
| m311 |  | . |
| m312 |  | . |
|  |  |  |
| e6 | Guinea pig epithelium | . |
| e7 | Pigeon droppings |  |
| e25 | Chicken serum |  |
| e26 | Parrot serum | spp. |
| e62 | Camel | . |
| e70 | Goose feathers | . |
| e71 | Mouse epithelium |  |
| e73 | Rat epithelium | . |
| e74 | Rat urine proteins |  |
| e75 | Rat serum proteins |  |
| e76 | Mouse serum proteins |  |
| e77 | Budgerigar droppings | . |
| e78 | Budgerigar feathers | . |
| e79 | Budgerigar serum proteins | . |
| e80 | Goat epithelium | . |
| e81 | Sheep epithelium |  |
| e82 | Rabbit epithelium |  |
| e83 | Swine epithelium |  |
| e84 | Hamster epithelium | . |
| e85 | Chicken feathers | (
                            
                             spp.). |
| e86 | Duck feathers | . |
| e87 | Rat epithelium, serum proteins, and urine proteins |  |
| e88 | Mouse epithelium, serum proteins, and urine proteins (mouse) | (
                            
                             spp.). |
| e89 | Turkey feathers | . |
| e90 | Budgerigar serum proteins, feathers, and droppings | . |
| e91 | Pigeon serum proteins, feathers, and droppings |  |
| e92 | Parrot serum proteins, feathers, and droppings | spp. |
| e93 | Pigeon serum proteins | . |
| e94 | Fel d 1.0101 | . |
| a345 | Fel d 1 | . |
| e98 | Parrot droppings | spp. |
| e101 | Can f 1.0101 | (
                            
                            ). |
| a174 | Can f 1 | (
                            
                            ). |
| e102 | Can f 2.0101 | (
                            
                            ). |
| e196 | Parakeet feathers | . |
| e197 | Parakeet droppings | . |
| e198 | Parakeet serum | . |
| e199 | Canary bird serum | . |
| e200 | Canary bird droppings | . |
| e201 | Canary bird feathers (Canary feathers) | . |
| e202 | Reindeer epithelium | . |
| e203 | Mink epithelium | spp. |
| e204 | Bos d 6 | (
                            
                             spp.). |
| e205 | Horse, serum proteins | (
                            
                             spp.). |
| e206 | Rabbit, serum proteins | (
                            
                             spp.). |
| e208 | Chinchilla epithelium | . |
| e209 | Gerbil epithelium | . |
| e210 | Fox epithelium | . |
| e211 | Rabbit, urine proteins |  |
| e212 | Swine, urine proteins |  |
| e213 | Parrot feathers | spp. |
| e214 | Finch feathers | . |
| e215 | Pigeon feathers |  |
| e216 | Deer epithelium | . |
| e217 | Ferret epithelium | . |
| e218 | Chicken droppings | (
                            
                             spp.). |
| e219 | Chicken, serum proteins | (
                            
                             spp.). |
| e220 | Fel d 2, Cat serum albumin | . |
| e221 | Can f 3 | (
                            
                            ) |
| e222 | Swine serum albumin (Sus s PSA) | (
                            
                             spp.). |
| e225 | Lovebird feathers | . |
| e226 | Can f 5.0101 | . |
| e227 | Equ c 1.0101 | . |
| e228 | Fel d 4.0101 | . |
| e230 | Equ c 3 | . |
| e231 | Mus m 1 | . |
|  |  |  |
| f9 | Rice | . |
| f12 | Pea (green pea) | . |
| f15 | White bean | . |
| f19 | Cayenne pepper |  |
| f21 | Sugar cane | . |
| f22 | Raspberry | . |
| f26 | Pork | (
                            
                             spp.). |
| f29 | Watermelon |  |
| f31 | Carrot | . |
| f32 | Oyster mushroom | . |
| f33 | Orange | . |
| f35 | Potato | . |
| f43 | Mother's milk | . |
| f44 | Strawberry | (
                            
                             spp.). |
| f45 | Yeast, baker's | . |
| f46 | Pepper, Red | . |
| f47 | Garlic | . |
| f48 | Onion | . |
| f49 | Apple |  |
| f51 | Bamboo shoot | . |
| f52 | Cacao/chocolate | . |
| f54 | Sweet potato | . |
| f55 | Common millet | . |
| f56 | Foxtail millet | . |
| f57 | Japanese millet | . |
| f58 | Pacific squid | . |
| f59 | Octopus | (
                            
                             spp.). |
| f63 | Kefir | NA. |
| f67 | Parmesan cheese | NA. |
| f81 | Cheese, cheddar type | NA. |
| f82 | Cheese, mold type | NA. |
| f83 | Chicken | (
                            
                             spp.). |
| f86 | Parsley | . |
| f87 | Melon | . |
| f88 | Mutton (lamb) | (
                            
                             spp.). |
| f90 | Malt | . |
| f92 | Banana | spp. |
| f93 | Cacao | . |
| f94 | Pear | (
                            
                             spp.). |
| f97 | Yam | spp. |
| f97 | Chamomile tea | . |
| f98 | Gliadin | (
                            
                             spp.). |
| f102 | Cantaloupe | . |
| f105 | Chocolate | . |
| f109 | Cottonseed | . |
| f110 | Giant radish | . |
| f118 | Zucchini | . |
| f119 | Radish | . |
| f120 | Venison | . |
| f121 | Pinto bean | . |
| f122 | Cheese, American | NA. |
| f127 | Black-eyed pea | . |
| f131 | Black Olive | . |
| f136 | Red beet | . |
| f139 | Goat's Cheese | . |
| f140 | Bran | NA. |
| f141 | Corn (vegetables) | . |
| f152 | Green bell pepper | . |
| f155 | Brewer's yeast | . |
| f157 | Duck | . |
| f158 | Goose | . |
| f160 | Camembert cheese | NA. |
| f162 | Nectarine | . |
| f163 | Kohlrabi | . |
| f65 | Perch |  |
| f166 | Leek | . |
| f170 | Cheese (Switzerland) (Swiss cheese) | NA. |
| f174 | Fig | . |
| f177 | Cranberry | . |
| f179 | Raisin | spp. |
| f182 | Lima bean | . |
| f198 | Flaxseed (bruised grain) | . |
| f199 | Untreated native milk | (
                            
                             spp.). |
| f208 | Lemon | . |
| f209 | Grapefruit | . |
| f210 | Pineapple | . |
| f211 | Blackberry | . |
| f212 | Mushroom (champignon) |  |
| f213 | Rabbit |  |
| f214 | Spinach | . |
| f215 | Lettuce | . |
| f216 | Cabbage | . |
| f217 | Brussels sprouts | . |
| f218 | Paprika, sweet pepper | . |
| f219 | Fennel seed | . |
| f219 | Sage | . |
| f220 | Cinnamon | spp. |
| f221 | Coffee | spp. |
| f222 | Tea | . |
| f223 | Green olive | . |
| f225 | Summer squash, pumpkin | . |
| f225 | Pumpkin | . |
| f226 | Pumpkin seed | . |
| f227 | Sugar-beet seed | . |
| f229 | Safflower Seed | . |
| f231 | Milk, boiled |  |
| f234 | Vanilla | . |
| f237 | Apricot | . |
| f241 | Gouda cheese | NA. |
| f242 | Cherry | . |
| f244 | Cucumber | . |
| f246 | Guar, guar gum | . |
| f247 | Honey | NA. |
| f248 | Rosemary | . |
| f254 | Plaice | . |
| f255 | Plum |  |
| f258 | Squid | spp. |
| f259 | Grape |  |
| f260 | Broccoli | (
                            
                            ). |
| f261 | Asparagus | . |
| f262 | Aubergine, eggplant | . |
| f263 | Green pepper |  |
| f264 | Eel | . |
| f265 | Caraway | . |
| f265 | Cumin | . |
| f266 | Mace | . |
| f267 | Cardamon | . |
| f268 | Clove | . |
| f269 | Basil | . |
| f270 | Ginger | . |
| f271 | Anise | . |
| f272 | Tarragon | . |
| f273 | Thyme | . |
| f274 | Marjoram | . |
| f275 | Lovage | . |
| f276 | Fennel, fresh | . |
| f277 | Dill | . |
| f278 | Bay leaf | . |
| f279 | Chili pepper | . |
| f280 | Black pepper | . |
| f281 | Curry (Santa Maria) | NA. |
| f282 | Nutmeg | . |
| f283 | Oregano | . |
| f284 | Turkey meat | . |
| f285 | Elk/moose meat | spp. |
| f286 | Mare's milk | (
                            
                             spp.). |
| f287 | Red kidney bean | . |
| f288 | Blueberry | (
                            
                             spp.). |
| f289 | Date | . |
| f291 | Cauliflower | . |
| f292 | Guava | . |
| f293 | Papaya | . |
| f294 | Passion fruit, Maracuja | (
                            
                             spp.). |
| f295 | Carambola | . |
| f296 | Carob | . |
| f297 | Gum arabic | (
                            
                             spp.). |
| f298 | Tragacanth | spp. |
| f299 | Sweet chestnut (chestnut) | . |
| f300 | Pinto bean | spp. |
| f301 | Persimmon (kaki fruit, sharon) | . |
| f302 | Mandarin (tangerine, clementine, satsumas) | . |
| f305 | Fenugreek | . |
| f306 | Lime | . |
| f307 | Hake | . |
| f308 | Sardine (pilchard) | . |
| f310 | Blue vetch | . |
| f311 | Megrim | . |
| f315 | Green bean | . |
| f316 | Rape seed | . |
| f317 | Coriander | . |
| f318 | Jack fruit | . |
| f319 | Beetroot | . |
| f320 | Crayfish | . |
| f321 | Horse meat | (
                            
                             spp.). |
| f322 | Red currant | . |
| f324 | Hop (fruit cone) | . |
| f325 | Saffron | . |
| f328 | Fig | . |
| f329 | Watermelon | . |
| f330 | Rose hip | spp. |
| f331 | Saffron | . |
| f332 | Mint | . |
| f333 | Linseed | . |
| f336 | Jujube | . |
| f336 | Wine vinegar | (
                            
                             spp.). |
| f337 | Sole | . |
| f337 | English sole | . |
| f338 | Wine, white | (
                            
                             spp.). |
| f339 | Allspice | . |
| f339 | Wine, red | (
                            
                             spp.). |
| f341 | Cranberry |  |
| f342 | Olive (black, fresh) | . |
| f343 | Raspberry | . |
| f344 | Sage | . |
| f346 | Chives | . |
| f347 | Quinoa | . |
| f348 | Litchi | . |
| f349 | Chum salmon roe | . |
| f358 | Artichoke | . |
| f360 | Yogurt | NA. |
| f368 | Black bass | (
                            
                            ). |
| f374 | Karaya gum | . |
| f375 | Horseradish | . |
| f377 | Maple syrup | NA. |
| f379 | Okra | . |
| f382 | Beet, sugar | . |
| f401 | Loquat | . |
| f402 | Fig | . |
| f403 | Brewer's yeast | . |
| f405 | Mint | spp. |
| f406 | Arugula | . |
|  |  |  |
| h1 | Greer Labs., Inc. | NA. |
| h2 | Hollister-Stier Labs. | NA. |
| h6 | Japan | NA. |
|  |  |  |
| i7 | Midge | . |
| i8 | Moth |  |
| i47 | Water flea | spp. |
| i49 | Deer fly | spp. |
| i51 | Black ant | . |
| i54 | Flea mix (dog/cat), common flea | spp. |
| i71 | Mosquito |  |
| i72 | Green nimitti | . |
| i73 | Blood worm |  |
| i75 | European hornet | . |
| i76 | Berlin beetle | . |
| i77 | European paper wasp | . |
| i78 | Fly | . |
| i80 | Bumblebee | . |
| i201 | Horse bot fly | . |
| i202 | Grain weevil | . |
| i203 | Mediterranean flour moth | (
                            
                            ). |
| i204 | Horse fly | spp. |
| i205 | Bumblebee | . |
| i208 | Api m 1.0101 | . |
| a45 | Api m 1 | . |
| i209 | Ves v 5.0101 | . |
| a670 | Ves v 5 | . |
| i210 | Pol d 5.0101 | . |
| i211 | Ves v 1.0101 | . |
| i213 | Api m 4 | . |
| i214 | Api m 2 | . |
| i215 | Api m 3 | . |
| i216 | Api m 5 | . |
| i217 | Api m 10 | . |
| i220 | Bla g 1.0101 | . |
| i221 | Bla g 2.0101 | . |
| i222 | Bla g 5.0101 | . |
| i223 | Bla g 7 |  |
| a46 | Api m 2 | . |
|  |  |  |
| o1 | Cotton, crude fibers | spp. |
| o3 | Cotton (treated) | spp. |
| o70 | Seminal fluid | . |
| o71 |  | . |
| o72 | crude extract customer specific | . |
| o72 | Sperm-sediment | . |
| o73 | crude extr. vector customer specific | . |
| o74 | with vector customer specific | . |
| o201 | Tobacco leaf, tobacco dust | . |
| o202 | Artemia salina, fish feed | . |
| o203 | Tetramin, fish feed | NA. |
| o207 | Daphnia, fish feed | spp. |
| o211 | Mealworm | . |
| o212 | Streptavidin | . |
| o213 | MBP (maltose binding protein) | . |
| o214 | CCD; MUXF3 from bromelain | . |
| o72 | Enterotoxin A (Sta a SEA) | . |
| o73 | Enterotoxin B (Sta a SEB) | . |
|  |  |  |
| p1 | Ascaris | . |
| p2 | Echinococcus | . |
| p3 | Schistosoma | . |
| p4 | Anisakis (Herring Worm) | (
                            
                             spp.). |
| p5 | Toxocara canis | . |
| p10 | Ani s 3.0101 | (
                            
                             spp.). |
| p11 | Ani s 1 | (
                            
                             spp.). |
|  |  |  |
| k4 | Threshing dust | NA. |
| k5 | Flax | NA. |
| k7 | Hay Dust | NA. |
| k8 | Hop (hops) | . |
| k12 | Grain mill dust | NA. |
| k14 | Kapok | NA. |
| k20 | Sheep's wool (treated) (wool) | (
                            
                             spp.). |
| k21 | Sheep's wool (Untreated) | (
                            
                             spp.). |
| k23 | Straw Dust | NA. |
| k33 | Oak | NA. |
| k70 | Green coffee bean | spp. |
| k71 | Castor bean | . |
| k72 | Ispaghula | . |
| k73 | Silk waste | NA. |
| k74 | Silk | . |
| k75 | Isocyanate TDI (Toluene diisocyanate) | NA. |
| k76 | Isocyanate MDI (Diphenylmethane diisocyanate) | NA. |
| k77 | Isocyanate HDI (Hexamethylen diisocyanate) | NA. |
| k78 | Ethylene oxide | NA. |
| k79 | Phthalic anhydride | NA. |
| k80 | Formaldehyde/Formalin | NA. |
| k81 | Ficus | (
                            
                             spp.). |
| k83 | Cotton seed | . |
| k84 | Sunflower seed | . |
| k85 | Chloramin T | NA. |
| k86 | Trimellitic anhydride, TMA | NA. |
| k87 | Asp o 21, alpha-amylase | . |
| k89 | Orris root | . |
| k99 | HSA (Human Serum Albumin) (Hom s HSA) | . |
| k201 | Car p 1, Papain | . |
| k202 | Ana c 2, Bromelain | . |
| k204 | Maxatase | . |
| k205 | Alcalase | spp. |
| k206 | Savinase, Protease 1 (Bac l Subtilisin) | spp. |
| k208 | Gal d 4, Lysozyme | (
                            
                             spp.). |
| k209 | Hexahydrophtalic anhydrid | NA. |
| k210 | Maleic anhydride | NA. |
| k211 | Methyltetrahydrophtalic anhydrid | NA. |
| k212 | Abachi wood dust | . |
| k213 | Pepsin (Sus s Pepsin) | (
                            
                             spp.). |
| k213 | TCPA | NA. |
| k214 | Bougainvillea | spp. |
| k225 | Horse radish peroxidase (Arm r HRP) | . |
| k226 | Ascorbate oxidase (Cuc p ascorbate oxidase) | . |
| k301 | Flour dust | spp. |
| k501 | Savinase customer specific | Proprietary knowledge of customer. |
| k502 | Lipolase customer specific | Proprietary knowledge of customer. |
| k503 | Termamyl customer specific | Proprietary knowledge of customer. |
| k504 | Clazinase customer specific | Proprietary knowledge of customer. |

**V. Reference**

The following reference is on display in the Dockets Management Staff (HFA-305), Food and Drug Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852, and is available for viewing by interested persons between 9 a.m. and 4 p.m., Monday through Friday; it is also available electronically at *https://www.regulations.gov.* FDA has verified the Web site address, as of the date this document publishes in the *Federal Register* , but Web sites are subject to change over time.

1. FDA Guidance, “Procedures for Class II Device Exemptions From Premarket Notification, Guidance for Industry and CDRH Staff,” February 19, 1998, available at *http://www.fda.gov/downloads/MedicalDevices/DeviceRegulationandGuidance/GuidanceDocuments/UCM080199.pdf.*

Dated: July 5, 2017.

Anna K. Abram,

Deputy Commissioner for Policy, Planning, Legislation, and Analysis.