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-
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.
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.
21 U.S.C. § 360g-2
EDITORIAL NOTES
CODIFICATIONSection 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.