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Financial Disclosure by Clinical Investigators

United States · Last verified: 2026-09-08

Number
21 CFR 54
Type
Regulation
Issuer
U.S. FDA
Status
in_force
Authority
FDA / CDRH

What this covers

临床研究者财务披露:申办者在 PMA、510(k) 等上市前申请中提交临床研究者财务利益信息的范围、认证与披露表要求,以及 FDA 的处理方式。

Official text: https://www.ecfr.gov/current/title-21/chapter-I/subchapter-A/part-54

Source: U.S. Food and Drug Administration (public domain)

Facts only; not legal advice. The official current text prevails.