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Medical Devices; Technical Amendment

---
identifier: "/us/fr/2013-06826"
source: "fr"
legal_status: "authoritative_unofficial"
title: "Medical Devices; Technical Amendment"
title_number: 0
title_name: "Federal Register"
section_number: "2013-06826"
section_name: "Medical Devices; Technical Amendment"
positive_law: false
currency: "2013-03-26"
last_updated: "2013-03-26"
format_version: "1.1.0"
generator: "[email protected]"
agency: "Health and Human Services Department"
document_number: "2013-06826"
document_type: "rule"
publication_date: "2013-03-26"
agencies:
  - "Health and Human Services Department"
  - "Food and Drug Administration"
cfr_references:
  - "21 CFR Part 814"
  - "21 CFR Part 822"
  - "21 CFR Part 862"
  - "21 CFR Part 864"
  - "21 CFR Part 866"
  - "21 CFR Part 868"
  - "21 CFR Part 870"
  - "21 CFR Part 872"
  - "21 CFR Part 874"
  - "21 CFR Part 876"
  - "21 CFR Part 878"
  - "21 CFR Part 880"
  - "21 CFR Part 882"
  - "21 CFR Part 884"
  - "21 CFR Part 886"
  - "21 CFR Part 888"
  - "21 CFR Part 890"
  - "21 CFR Part 892"
fr_citation: "78 FR 18233"
fr_volume: 78
docket_ids:
  - "Docket No. FDA-2013-N-0011"
effective_date: "2013-03-26"
fr_action: "Final rule; technical amendment."
---

#  Ophthalmic camera.

**AGENCY:**

Food and Drug Administration, HHS.

**ACTION:**

Final rule; technical amendment.

**SUMMARY:**

The Food and Drug Administration (FDA) is amending certain medical device regulations to correct minor errors in the Code of Federal Regulations (CFR). This action is editorial in nature and is intended to provide accuracy and clarity to the Agency's regulations.

**DATES:**

This rule is effective March 26, 2013.

**FOR FURTHER INFORMATION CONTACT:**

Abigail Corbin, Center for Devices and Radiological Health, Food and Drug Administration, 10903 New Hampshire Ave. Bldg. 66, rm. 4430, Silver Spring, MD 20993-0002, 301-796-9142.

**SUPPLEMENTARY INFORMATION:**

FDA is amending certain regulations in 21 CFR parts 814, 822, 862, 864, 866, 868, 870, 872, 874, 876, 878, 880, 882, 884, 886, 888, 890, and 892. This action corrects minor spelling errors and outdated Web site addresses affecting certain regulations regarding medical devices.

Publication of this document constitutes final action of these changes under the Administrative Procedure Act (5 U.S.C. 553). These amendments are merely correcting nonsubstantive errors. FDA therefore, for good cause, finds under 5 U.S.C. 553(b)(3)(B) and (d)(3) that notice and public comment are unnecessary.

FDA has determined under 21 CFR 25.30(i) that this final rule is of a type that does not individually or cumulatively have a significant effect on the human environment. Therefore, neither an environmental assessment nor an environmental impact statement is required. In addition, FDA has determined that this final rule contains no collection of information. Therefore, clearance by the Office of Management and Budget under the Paperwork Reduction Act of 1995 is not required.

**List of Subjects**

Administrative practice and procedure, Confidential business information, Medical devices, Medical research, Reporting and recordkeeping requirements.

Medical devices, Reporting and recordkeeping requirements.

Medical devices.

Blood, Medical devices, Packaging and containers.

Biologics, Laboratories, Medical devices.

Medical devices.

Medical devices, Neurological devices.

Medical devices.

Medical devices, Ophthalmic goods and services.

Medical devices.

Medical devices, Physical medicine devices.

Medical devices, Radiation protection, X-rays.

Therefore, under the Federal Food, Drug, and Cosmetic Act, and under authority delegated to the Commissioner of Food and Drugs, 21 CFR Chapter I is amended as follows:

**21 CFR Part 814**

§§ 814.20, 822.7, 822.15, 862.1, 864.1, 866.1, 868.1, 870.1, 872.1, 874.1, 876.1, 878.1, 880.1, 882.1, 884.1, 886.1, 888.1, 890.1, and 892.1

1. In the table below, for each section indicated in the left column, remove the Web address indicated in the middle column from wherever it appears in the section, and add the Web address indicated in the right column:

| Section | Remove | Add |
| --- | --- | --- |
| 814.20 |  |  |
| 822.7 |  |  |
| 822.15 | www.fda.gov/cdrh/ombudsman/ |  |
| 862.1, 864.1, 866.1, 868.1, 870.1, 872.1, 874.1, 876.1, 878.1, 880.1, 882.1, 884.1, 886.1, 888.1, 890.1, and 892.1 |  |  |

**PART 870—CARDIOVASCULAR DEVICES**

2. The authority citation for 21 CFR part 870 continues to read as follows:

**Authority:**

21 U.S.C. 351, 360, 360c, 360e, 360j, 371.

3. Amend § 870.3600 by revising the second sentence in paragraph (a) to read as follows:

§ 870.3600

(a) *Identification.* * * * This device, which is used outside the body, is used as a temporary substitute for the heart's intrinsic pacing system until a permanent pacemaker can be implanted, or to control irregular heartbeats in patients following cardiac surgery or a myocardial infarction. * * *

4. Amend § 870.5300 by revising the section heading to read as follows:

§ 870.5300

**PART 882—NEUROLOGICAL DEVICES**

5. The authority citation for 21 CFR part 882 continues to read as follows:

**Authority:**

21 U.S.C. 351, 360, 360c, 360e, 360j, 371.

6. Amend § 882.5870 by revising the second sentence in paragraph (a) to read as follows:

§ 882.5870

(a) *Identification.* * * * The stimulator consists of an implanted receiver with electrodes that are placed around a peripheral nerve and an external transmitter for transmitting the stimulating pulses across the patient's skin to the implanted receiver.

**PART 886—OPHTHALMIC DEVICES**

7. The authority citation for 21 CFR part 886 continues to read as follows:

**Authority:**

21 U.S.C. 351, 360, 360c, 360e, 360j, 371.

8. Amend § 886.1120 by revising the section heading to read as follows:

§ 886.1120

Dated: March 20, 2013.

Leslie Kux,

Assistant Commissioner for Policy.