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Code · BILL · 117th Congress · H.R. 6000 (Introduced in House) — To continue the acceleration of the discovery, development, and delivery of 21st century cures, and for other purposes. · Sec. 310

Sec. 310. Recommendations to decentralize clinical trials

153 words·~1 min read·/bill/117/hr/6000/ih/section-310·

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Not later than the end of fiscal year 2022, the Secretary of Health and Human Services, acting through the Commissioner of Food and Drugs, shall convene a meeting of covered representatives to recommend to the Secretary innovative approaches and incentives to adopt decentralized clinical trials. In this section: The term covered representative means a representative of the following: Sponsors of an application for approval of a drug under section 505 of the Federal Food, Drug, and Cosmetic Act ( 21 U.S.C. 355 ).
A manufacturer of a device (as defined in section 201 of the Federal Food, Drug, and Cosmetic Act ( 21 U.S.C. 321 )). Clinical research organizations. The technology community. The patient community. The term decentralized clinical trial means a clinical trial method that includes the use of telemedicine or digital technologies to allow for the remote collection of clinical trial data from subjects, including in the home or office setting.
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Sec. 310
Recommendations to decentralize clinical trials
U.S.C.§ 355
U.S.C.§ 321
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