§360g–2 — Title 21 Food and Drugs | U.S. Code

Summary

When the Secretary uses studies or data 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, assumptions, methods, analysis code, results, and other parts of the work. If that information is used to support a decision, the Secretary should, when practicable, give the device maker a summary while protecting trade secrets and personal information. By September 30, 2023, and every two years after, the Secretary must send and post a report to the Senate Committee on Health, Education, Labor, and Pensions and the House Committee on Energy and Commerce describing how many postmarket device signals communications were issued, the data sources for them, and how those signals were changed or resolved. This does not force the FDA to delay any decision or action.

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.

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.

§360g–2 Third party data transparency

Summary

Title 21, §360g–2

Notes & Related Subsidiaries

Editorial Notes

Statutory Notes and Related Subsidiaries

Citations & Metadata