90 FR 126 pgs. 29552-29554 - Agency Information Collection Activities; Proposed Collection; Comment Request; 510(k) Third-Party Review Program
Type: NOTICEVolume: 90Number: 126Pages: 29552 - 29554
Pages: 29552, 29553, 29554Docket number: [Docket No. FDA-2025-N-1108]
FR document: [FR Doc. 2025-12416 Filed 7-2-25; 8:45 am]
Agency: Health and Human Services Department
Sub Agency: Food and Drug Administration
Official PDF Version: PDF Version
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2025-N-1108]
Agency Information Collection Activities; Proposed Collection; Comment Request; 510(k) Third-Party Review Program
AGENCY:
Food and Drug Administration, HHS.
ACTION:
Notice.
SUMMARY:
The Food and Drug Administration (FDA or Agency) is announcing an opportunity for public comment on the proposed collection of certain information by the Agency. Under the Paperwork Reduction Act of 1995 (PRA), Federal Agencies are required to publish notice in the Federal Register concerning each proposed collection of information, including each proposed extension of an existing collection of information, and to allow 60 days for public comment in response to the notice. This notice solicits comments on information collection associated with the 510(k) Third-Party Review Program.
DATES:
Either electronic or written comments on the collection of information must be submitted by September 2, 2025.
ADDRESSES:
You may submit comments as follows. Please note that late, untimely filed comments will not be considered. The https://www.regulations.gov electronic filing system will accept comments until 11:59 p.m. Eastern Time at the end of September 2, 2025. Comments received by mail/hand delivery/courier (for written/paper submissions) will be considered timely if they are received on or before that date.
Electronic Submissions
Submit electronic comments in the following way:
• Federal eRulemaking Portal: https://www.regulations.gov. Follow the instructions for submitting comments. Comments submitted electronically, including attachments, to https://www.regulations.gov will be posted to the docket unchanged. Because your comment will be made public, you are solely responsible for ensuring that your comment does not include any confidential information that you or a third party may not wish to be posted, such as medical information, your or anyone else's Social Security number, or confidential business information, such as a manufacturing process. Please note that if you include your name, contact information, or other information that identifies you in the body of your comments, that information will be posted on https://www.regulations.gov.
• If you want to submit a comment with confidential information that you do not wish to be made available to the public, submit the comment as a written/paper submission and in the manner detailed (see "Written/Paper Submissions" and "Instructions").
Written/Paper Submissions
Submit written/paper submissions as follows:
• Mail/Hand Delivery/Courier (for written/paper submissions): Dockets Management Staff (HFA-305), Food and Drug Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852.
• For written/paper comments submitted to the Dockets Management Staff, FDA will post your comment, as well as any attachments, except for information submitted, marked and identified, as confidential, if submitted as detailed in "Instructions."
Instructions: All submissions received must include the Docket No. [FDA-2025-N-1108] for "Agency Information Collection Activities; Proposed Collection; Comment Request; 510(k) Third-Party Review Program." Received comments, those filed in a timely manner (see ADDRESSES ), will be placed in the docket and, except for those submitted as "Confidential Submissions," publicly viewable at https://www.regulations.gov or at the Dockets Management Staff between 9 a.m. and 4 p.m., Monday through Friday, 240-402-7500.
• Confidential Submissions-To submit a comment with confidential information that you do not wish to be made publicly available, submit your comments only as a written/paper submission. You should submit two copies total. One copy will include the information you claim to be confidential with a heading or cover note that states "THIS DOCUMENT CONTAINS CONFIDENTIAL INFORMATION." The Agency will review this copy, including the claimed confidential information, in its consideration of comments. The second copy, which will have the claimed confidential information redacted/blacked out, will be available for public viewing and posted on https://www.regulations.gov. Submit both copies to the Dockets Management Staff. If you do not wish your name and contact information to be made publicly available, you can provide this information on the cover sheet and not in the body of your comments and you must identify this information as "confidential." Any information marked as "confidential" will not be disclosed except in accordance with 21 CFR 10.20 and other applicable disclosure law. For more information about FDA's posting of comments to public dockets, see 80 FR 56469, September 18, 2015, or access the information at: https://www.govinfo.gov/content/pkg/FR-2015-09-18/pdf/2015-23389.pdf.
[top] Docket: For access to the docket to read background documents or the electronic and written/paper comments received, go to https://www.regulations.gov and insert the docket number, found in brackets in the heading of this document, into the "Search" box and follow the prompts
FOR FURTHER INFORMATION CONTACT:
Amber Sanford, Office of Operations, Food and Drug Administration, Three White Flint North, 10A-12M, 11601 Landsdown St., North Bethesda, MD 20852, 301-796-8867, PRAStaff@fda.hhs.gov.
SUPPLEMENTARY INFORMATION:
Under the PRA (44 U.S.C. 3501-3521), Federal Agencies must obtain approval from the Office of Management and Budget (OMB) for each collection of information they conduct or sponsor. "Collection of information" is defined in 44 U.S.C. 3502(3) and 5 CFR 1320.3(c) and includes Agency requests or requirements that members of the public submit reports, keep records, or provide information to a third party. Section 3506(c)(2)(A) of the PRA (44 U.S.C. 3506(c)(2)(A)) requires Federal Agencies to provide a 60-day notice in the Federal Register concerning each proposed collection of information, including each proposed extension of an existing collection of information, before submitting the collection to OMB for approval. To comply with this requirement, FDA is publishing notice of the proposed collection of information set forth in this document.
With respect to the following collection of information, FDA invites comments on these topics: (1) whether the proposed collection of information is necessary for the proper performance of FDA's functions, including whether the information will have practical utility; (2) the accuracy of FDA's estimate of the burden of the proposed collection of information, including the validity of the methodology and assumptions used; (3) ways to enhance the quality, utility, and clarity of the information to be collected; and (4) ways to minimize the burden of the collection of information on respondents, including through the use of automated collection techniques, when appropriate, and other forms of information technology.
Agency Information Collection Activities; Proposed Collection; Comment Request; 510(k) Third-Party Review Program
OMB Control Number 0910-0375-Revision
Section 523 of the Federal Food, Drug, and Cosmetic Act (FD&C Act) (21 U.S.C. 360m), directs FDA to accredit persons in the private sector to review certain premarket notifications (510(k)s; see 21 U.S.C. 360(k)). Participation in the 510(k) third party (3P510k) review program by accredited persons is entirely voluntary. A third party wishing to participate will submit a request for accreditation to FDA. Accredited third-party reviewers have the ability to review a manufacturer's 510(k) submission for selected devices. After reviewing a submission, the reviewer will forward a copy of the 510(k) submission, along with the reviewer's documented review and recommendation, to FDA. Third-party reviewers should maintain records of their 510(k) reviews and a copy of the 510(k) for a reasonable period of time, usually 3 years. The 3P510k review program is intended to allow review of devices by third-party 510k review organizations (3PROs) to provide manufacturers of these devices an alternative review process that allows FDA to best utilize our resources on higher risk devices.
Respondents to this information collection are businesses or government and can be for-profit or not-for-profit organizations, such as third party review organizations.
The guidance "510(k) Third-Party Review Program, Guidance for Industry, Food and Drug Administration Staff and Third Party Review Organizations" (March 2020) was intended to provide a comprehensive look into FDA's current thinking regarding the 3P510k program and third party review of Emergency Use Authorization (EUA) requests by describing FDA's expectations for the review of 510(k) submissions and EUA requests by third party review organizations. This guidance document also reflects section 523 of the FD&C Act, which directs FDA to issue guidance on the factors that will be used in determining whether a class I or class II device type, or subset of such device types, is eligible for review by an accredited person. This guidance was superseded on November 21, 2024, when FDA issued the final guidance "510(k) Third Party Review Program and Third Party Emergency Use Authorization (EUA) Review; Guidance for Industry, Food and Drug Administration Staff, and Third Party Review Organizations" (November 2024) (available at https://www.fda.gov/regulatory-information/search-fda-guidance-documents/510k-third-party-review-program-and-third-party-emergency-use-authorization-eua-review ). The guidance also includes new content that outlines how FDA may contract with third party review organizations to perform reviews of EUA requests (3PEUA review) when appropriate emergency declaration authorities are active under section 564 of the FD&C Act. (See OMB Control Number 0910-0595.)
FDA estimates the burden of this collection of information as follows:
| Activity; guidance document section | Number of respondents | Number of responses per respondent | Total annual responses | Average burden per response | Total hours |
|---|---|---|---|---|---|
| Requests for accreditation (initial); Section V.D | 1 | 1 | 1 | 40 | 40 |
| Requests for accreditation (re-recognition); Section V.D | 3 | 1 | 3 | 24 | 72 |
| 510(k) reviews conducted by 3PROs; Section V.B | 9 | 14 | 126 | 40 | 5,040 |
| Complaints; Section V.C | 1 | 1 | 1 | 0.25 (15 minutes) | 0.25 |
| Total | 5,152.25 | ||||
| 1 ?There are no capital costs or operating and maintenance costs associated with this collection of information. | |||||
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| Activity; guidance document section | Number of recordkeepers | Number of records per recordkeeper | Total annual records | Average burden per recordkeeping | Total hours |
|---|---|---|---|---|---|
| 510(k) reviews conducted by 3PROs; Section V.B | 9 | 14 | 126 | 10 | 1,260 |
| Records regarding qualifications to receive FDA recognition as a 3PRO; Section V.C | 9 | 1 | 9 | 1 | 9 |
| Recordkeeping system regarding complaints; Section V.C | 9 | 1 | 9 | 2 | 18 |
| Total | 1,287 | ||||
| 1 ?There are no capital costs or operating and maintenance costs associated with this collection of information. | |||||
Upon review of this information collection, we have adjusted our burden estimate for the average burden hours required per response for initial requests for accreditation from 24 to 40 hours to more accurately reflect the time required based on recent experience of FDA program staff. This adjustment has resulted in an increase of 15 hours to the currently approved burden.
Dated: June 26, 2025.
Grace R. Graham,
Deputy Commissioner for Policy, Legislation, and International Affairs.
[FR Doc. 2025-12416 Filed 7-2-25; 8:45 am]
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