# Agency Information Collection Activities; Proposed Collection; Comment Request; Investigational Device Exemptions Reports and Records
**AGENCY:**
Food and Drug Administration, HHS.
**ACTION:**
Notice.
**SUMMARY:**
The Food and Drug Administration (FDA) is announcing that a proposed collection of information has been submitted to the Office of Management and Budget (OMB) for review and clearance under the Paperwork Reduction Act of 1995.
**DATES:**
Submit written comments (including recommendations) on the collection of information by March 30, 2026.
**ADDRESSES:**
To ensure that comments on the information collection are received, OMB recommends that written comments be submitted to *https://www.reginfo.gov/public/do/PRAMain.* Find this particular information collection by selecting “Currently under Review—Open for Public Comments” or by using the search function. The OMB control number for this information collection is 0910-0078.
**FOR FURTHER INFORMATION CONTACT:**
Amber Barrett, Office of Operations, Food and Drug Administration, Three White Flint North, 10A-12M, 11601 Landsdown St., North Bethesda, MD 20852, 301-796-8867, *[email protected].*
**SUPPLEMENTARY INFORMATION:**
In compliance with 44 U.S.C. 3507, FDA has submitted the following proposed collection of information to OMB for review and clearance.
**Investigational Device Exemptions Reports and Records—21 CFR Part 812**
**OMB Control Number 0910-0078—Extension**
This information collection supports implementation of section 520(g) of the Federal Food, Drug, and Cosmetic Act (FD&C Act) (21 U.S.C. 360j(g)), which governs exemption for devices for investigational use. An investigational device exemption (IDE) allows a device to be used in investigations involving human subjects in which the safety and effectiveness of the device is being studied. For more information regarding IDE, please visit our website at * https:// www.fda.gov/medical-devices/premarket-submissions-selecting-and-preparing-correct-submission/investigational-device-exemption-ide. *
FDA has promulgated regulations in part 812 (21 CFR part 812) intended to encourage the discovery and development of useful devices intended for human use. The regulations set forth the scope and applicability of exemption requirements for devices for investigational use, as well as establish application procedures, corresponding instruction, and provisions for emergency research. The regulations also provide for requesting waivers from the requirements; and explain sponsor responsibilities, including requirements for institutional review board (IRB) review and approval. Finally, the regulations in part 812, subpart G (21 CFR 812.140, 812.145, and 812.150) provide for required recordkeeping, the inspection of records, and the preparation and submission of reports to FDA and/or IRBs that oversee medical device investigations. The information collection also includes recommended recordkeeping discussed in the document, “Guidance on Informed Consent for In Vitro Diagnostic Device Studies Using Leftover Human Specimens that are Not Individually Identifiable” (April 2006), available for download at GFI IVD Leftover Specimens April 2006, and previously approved under OMB control no. 0910-0582. The guidance document explains that FDA does not intend to object to the use, without informed consent, of leftover human specimens—remnants of specimens collected for routine clinical care or analysis that would otherwise have been discarded—in investigations that meet the criteria for exemption in 21 CFR 812.2(c)(3), as long as subject privacy is protected by using only specimens that are not individually identifiable. The guidance document was developed and issued in accordance with our Good Guidance Practice regulations (21 CFR 10.115), which provide for public comment at any time.
| Activity/21 CFR section | Number of | Number of | Total annual | Average burden | Total hours |
| --- | --- | --- | --- | --- | --- |
| 812.10; waivers | 1 | 1 | 1 | 1 | 1 |
| 812.20, 812.25, and 812.27; applications, investigational plans, and supplements | 288 | 1 | 288 | 80 | 23,040 |
| 812.27(b)(4)(i); prior investigations within the United States | 504 | 1 | 504 | 1 | 504 |
| 812.27(b)(4)(ii); prior investigations outside the United States | 126 | 1 | 126 | 0.25 (15 minutes) | 32 |
| 812.28; acceptance of data from clinical investigations conducted outside the United States, and supporting information | 1,500 | 1 | 1,500 | 10.25 | 15,375 |
| 812.28(c); waivers | 10 | 1 | 10 | 1 | 10 |
| 812.35 and 812.150; application supplements | 824 | 5 | 4,120 | 6 | 24,720 |
| 812.36(c); treatment IDE applications | 1 | 1 | 1 | 120 | 120 |
| 812.36(f); treatment IDE reports | 1 | 1 | 1 | 20 | 20 |
| 812.150; non-significant risk study reports to third parties | 1 | 1 | 1 | 6 | 6 |
| Total | | | 6,552 | | 63,828 |
In the *Federal Register* of August 22, 2025 (90 FR 41087) FDA published a 60-day notice requesting public comment on the proposed collection of information. No comments were received.
FDA estimates the burden of this collection of information as follows:
| Activity/21 CFR section | Number of | Number of | Total annual | Average | Total hours |
| --- | --- | --- | --- | --- | --- |
| 812.2(c)(3); records regarding leftover specimens not individually identifiable used in certain studies | 700 | 1 | 700 | 4 | 2,800 |
| 812.28(d); records for clinical investigations conducted outside United States | 1,500 | 1 | 1,500 | 1 | 1,500 |
| 812.140; retention of records | 1,249 | 3.09 | 3,859 | 1.9937 | 7,694 |
| Total | | | 6,059 | | 11,994 |
Our estimated burden for the information collection reflects an overall increase of 9,919 hours and a corresponding increase of 1,033 responses. We attribute this adjustment to an increase in the number of submissions we received over the last few years.
Grace R. Graham,
Deputy Commissioner for Policy, Legislation, and International Affairs.