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Title 21, Food and DrugsRelease 119-73not60

§360g–2 Third Party Data Transparency

Title 21 › Chapter 9— FEDERAL FOOD, DRUG, AND COSMETIC ACT › Subchapter V— DRUGS AND DEVICES › Part A— Drugs and Devices › § 360g–2

Last updated Apr 5, 2026|Official source

Summary

When the Secretary relies on data, analysis, or other findings that were paid for by, or done under contract with, the FDA to make decisions about medical devices, the Secretary must ask for the underlying datasets, inputs, assumptions, methods, code, results, and other parts used to reach those findings. If those materials are used to support a regulatory decision, the Secretary must, when practical, give the device maker a summary of them while protecting trade secrets and personal or confidential business information. By September 30, 2023, and every two years after, the Secretary must send a report to the Senate Committee on Health, Education, Labor, and Pensions and the House Committee on Energy and Commerce and post it on the FDA website. The report must list how many communications about postmarket device signals were issued, where the data came from, and how those signals were changed or resolved. Nothing in these rules requires delaying any FDA decision or action.

Full Legal Text

Title 21, §360g–2

Food and Drugs, Source: USLM XML via OLRC

(a)To the extent the Secretary relies on any data, analysis, or other information or findings provided by entities that has been funded in whole or in part by, or otherwise performed under contract with, the Food and Drug Administration, in regulatory decision-making with respect to devices, the Secretary shall—
(1)request access to the datasets, inputs, clinical or other assumptions, methods, analytical code, results, and other components underlying or comprising the analysis, conclusions, or other findings upon which the Secretary seeks to rely; and
(2)in the event that information described in paragraph (1) is used to support regulatory decision-making, and as otherwise appropriate, to the extent practicable, provide the manufacturer or manufacturers subject to such decision a summary of such information, subject to protection of confidential commercial information or trade secret information or personally identifiable information.
(b)Not later than September 30, 2023, and biennially thereafter, the Secretary shall submit to the Committee on Health, Education, Labor, and Pensions of the Senate and the Committee on Energy and Commerce of the House of Representatives, and publish on the website of the Food and Drug Administration, a report on the number of postmarket device signals communications issued by the Secretary, the sources of data for such signals, and how such signals were revised or resolved.
(c)Nothing in this section shall be construed to require the delay of any regulatory decision-making or other action of the Food and Drug Administration.

Legislative History

Notes & Related Subsidiaries

Editorial Notes

Codification Section was enacted as part of the Food and Drug Omnibus Reform Act of 2022, and not as part of the Federal Food, Drug, and Cosmetic Act which comprises this chapter.

Statutory Notes and Related Subsidiaries

Definition of “Secretary” Secretary as used in this section means the Secretary of Health and Human Services, see section 3002 of div. FF of Pub. L. 117–328, set out as a note under section 350a–1 of this title.

Reference

Citations & Metadata

Citation

21 U.S.C. § 360g–2

Title 21, Food and Drugs

Last Updated

Apr 5, 2026

Release point: 119-73not60