510(k) Third-Party Review Program

Forms and Documents

Document	Type	Status	Availability
0910-0375_Supporting Statement A_2025.docx	Supporting Statement A	Uploaded 2025-11-28	Available

IC Document Collections

IC ID	Collection	Type	Status	Form
6015	510(k) Third-Party Review Program	Other-Guidance; 510(k) Third Party Review Program and Third Part	Modified

ICR Details

OMB Control No: 0910-0375	ICR Reference No: 202504-0910-003
Status: Received in OIRA	Previous ICR Reference No: 202203-0910-002
Agency/Subagency: HHS/FDA	Agency Tracking No: CDRH
Title: 510(k) Third-Party Review Program
Type of Information Collection: Revision of a currently approved collection	Common Form ICR:  No
Type of Review Request: Regular	Date Submitted to OIRA: 12/01/2025

	Requested	Previously Approved
Expiration Date	36 Months From Approved	04/30/2026
Responses	275	275
Time Burden (Hours)	6,439	6,424
Cost Burden (Dollars)	0	0

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Abstract: This ICR collects information from persons who wish to be accredited by the Agency to review certain premarket notifications. Participation in this third-party 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 premarket notification for selected medical devices. After reviewing a submission, the reviewer will forward a copy of the submission, along with the reviewer's documented review and recommendation to FDA. Third-party reviewers also maintain records of their reviews and a copy of the submission. The purpose of the program is: (1) to provide manufacturers of eligible devices with an alternative review process that could yield more rapid marketing clearance decisions and (2) enable FDA to target its scientific review resources at higher-risk devices while maintaining confidence in the review by third parties of low-to-moderate risk devices.

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Authorizing Statute(s): US Code: 21 USC 523
  

Citations for New Statutory Requirements: None

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Associated Rulemaking Information
RIN:	Stage of Rulemaking:	Federal Register Citation:	Date:
	Not associated with rulemaking

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Federal Register Notices & Comments
60-day Notice:	Federal Register Citation:	Citation Date:
	90 FR 29552	07/03/2025
30-day Notice:	Federal Register Citation:	Citation Date:
	90 FR 52971	11/24/2025
Did the Agency receive public comments on this ICR? No

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Number of Information Collection (IC) in this ICR: 1

IC Title	Form No.	Form Name
510(k) Third-Party Review Program

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ICR Summary of Burden

	Total Request	Previously Approved	Change Due to New Statute	Change Due to Agency Discretion	Change Due to Adjustment in Estimate	Change Due to Potential Violation of the PRA
Annual Number of Responses	275	275	0	0	0	0
Annual Time Burden (Hours)	6,439	6,424	0	0	15	0
Annual Cost Burden (Dollars)	0	0	0	0	0	0

Burden increases because of Program Change due to Agency Discretion: No

Burden Increase Due to:

Burden decreases because of Program Change due to Agency Discretion: No

Burden Reduction Due to:

Short Statement: Based on our experience with the program since our last request for OMB approval, we have adjusted our burden estimate. We have increased our burden estimate for the average burden hours required per response for initial requests for accreditation from 24 hours 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. We made no other adjustments to our burden estimate. The guidance “510(k) Third-Party Review Program, Guidance for Industry, Food and Drug Administration Staff and Third Party Review Organizations” (March 2020) 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).

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Annual Cost to Federal Government: $6,946

Does this IC contain surveys, censuses, or employ statistical methods? No

Does this ICR request any personally identifiable information (see OMB Circular No. A-130 for an explanation of this term)? Please consult with your agency's privacy program when making this determination.     Yes

Does this ICR include a form that requires a Privacy Act Statement (see 5 U.S.C. §552a(e)(3))? Please consult with your agency's privacy program when making this determination.     No

Is this ICR related to the Affordable Care Act [Pub. L. 111-148 & 111-152]? No

Is this ICR related to the Dodd-Frank Wall Street Reform and Consumer Protection Act, [Pub. L. 111-203]? No

Is this ICR related to the American Recovery and Reinvestment Act of 2009 (ARRA)? No

Is this ICR related to the Pandemic Response? No

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Common Form ICR:  No

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On behalf of this Federal agency, I certify that the collection of information encompassed by this request complies with 5 CFR 1320.9 and the related provisions of 5 CFR 1320.8(b)(3).

The following is a summary of the topics, regarding the proposed collection of information, that the certification covers:

(a) It is necessary for the proper performance of agency functions;

(b) It avoids unnecessary duplication;

(c) It reduces burden on small entities;

(d) It uses plain, coherent, and unambiguous language that is understandable to respondents;

(e) Its implementation will be consistent and compatible with current reporting and recordkeeping practices;

(f) It indicates the retention periods for recordkeeping requirements;

(g) It informs respondents of the information called for under 5 CFR 1320.8 (b)(3) about:

(i) Why the information is being collected;

(ii) Use of information;

(iii) Burden estimate;

(iv) Nature of response (voluntary, required for a benefit, or mandatory);

(v) Nature and extent of confidentiality; and

(vi) Need to display currently valid OMB control number;

(h) It was developed by an office that has planned and allocated resources for the efficient and effective management and use of the information to be collected.

(i) It uses effective and efficient statistical survey methodology (if applicable); and

(j) It makes appropriate use of information technology.

If you are unable to certify compliance with any of these provisions, identify the item by leaving the box unchecked and explain the reason in the Supporting Statement.

Certification Date: 12/01/2025

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