View the PDF for 21 CFR Part 50; These links go to the official, published CFR, which is updated annually. As a result, it may not include the most recent changes applied to the CFR. Learn more.

Dec 24, 2024 · For the most up-to-date version of CFR Title 21, go to the Electronic Code of Federal Regulations (eCFR). Note: If you need help accessing information in different file …

Electronic Code of Federal Regulations (e-CFR) Title 21—Food and Drugs; CHAPTER I—FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES; …

PART 50 - PROTECTION OF HUMAN SUBJECTS Authority: 21 U.S.C 321, 343, 346, 346a, 348, 350a, 350b, 352, 353, 355, 360, 360c-360f, 360h-360j, 371, 379e, 381; 42 U.S.C. 216, 241, …

FDA is charged by statute with ensuring the protection of the rights, safety, and welfare of human subjects who participate in clinical investigations involving articles subject to section 505 (i),...

§50.1 21 CFR Ch. I (4–1–20 Edition) knowledge about the subjects’ disorder or condition. 50.54 Clinical investigations not otherwise approvable that present an opportunity to understand, …

Title 21 was last amended 5/12/2025. § 50.25 Elements of informed consent. (a) Basic elements of informed consent. In seeking informed consent, the following information shall be provided …

On its own initiative, the agency is also adopting amendments to the Investigational Device Exemptions (IDE) regulations (21 CFR Part 812) to conform them to Part 50.

Mar 30, 2012 · FDA should clarify the interpretation of “clinical investigation” based on the regulatory definitions found in 21 CFR 50, 21 CFR 56, 21 CFR 312, and 21 CFR 812.

Aug 30, 2024 · § 50.50 - IRB duties. § 50.51 - Clinical investigations not involving greater than minimal risk. § 50.52 - Clinical investigations involving greater than minimal risk but presenting …