C.F.R. » Title 21 » CHAPTER I—FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES › SUBCHAPTER A—GENERAL › PART 50—PROTECTION OF HUMAN SUBJECTS › Subpart A—General Provisions

21 C.F.R. § 50.1

Scope

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(a) This part applies to all clinical investigations regulated by the Food and Drug Administration under sections 505(i) and 520(g) of the Federal Food, Drug, and Cosmetic Act, as well as clinical investigations that support applications for research or marketing permits for products regulated by the Food and Drug Administration, including foods, including dietary supplements, that bear a nutrient content claim or a health claim, infant formulas, food and color additives, drugs for human use, medical devices for human use, biological products for human use, and electronic products. Additional specific obligations and commitments of, and standards of conduct for, persons who sponsor or monitor clinical investigations involving particular test articles may also be found in other parts (e.g., parts 312 and 812). Compliance with these parts is intended to protect the rights and safety of subjects involved in investigations filed with the Food and Drug Administration pursuant to sections 403, 406, 409, 412, 413, 502, 503, 505, 510, 513-516, 518-520, 721, and 801 of the Federal Food, Drug, and Cosmetic Act and sections 351 and 354-360F of the Public Health Service Act.

(b) References in this part to regulatory sections of the Code of Federal Regulations are to chapter I of title 21, unless otherwise noted.

[45 FR 36390, May 30, 1980; 46 FR 8979, Jan. 27, 1981, as amended at 63 FR 26697, May 13, 1998; 64 FR 399, Jan. 5, 1999; 66 FR 20597, Apr. 24, 2001]
Notes of Decisions
Cited in 7 cases (5 in the last 5 years), 1984–2025 · leading case: Larry Leon Chaney v. Margaret M. Heckler, as Secretary of Health and Human Services
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Larry Leon Chaney v. Margaret M. Heckler, as Secretary of Health and Human Services (1984) cadc “See 21 C.F.R. § 50.1 et seq. (1983). Finally, it is established doctrine that, unless Congress has specifically otherwise decided, resort to litigation on a private cause of action is not an adequate alternative to an administrative agency performing its lawful function.”
Daum v. SpineCare Medical Group, Inc. (1997) calctapp “” ( 21 C.F.R. § 50.1 (a) (1996).) They are “intended to protect the rights and safety of subjects involved in investigations filed with the Food and Drug Administration .”
Vasquez v. City of New York (2024) nyed “23 and citing 21 C.F.R. § 50.1 (a), which describes the regulation’s scope).”
Mongielo v. Hochul (2023) nywd “20 does not create a private right of action either, see 21 C.F.R § 50.1 (“This part applies to all clinical investigations regulated by the Food and Drug Administration under .”
Behm v. Mehaljevic (2024) ohnd “21 C.F.R. § 50.1 (a).3 Even liberally construed, the facts in this case do not suggest Plaintiff was part of an FDA-regulated clinical drug trial.”
Garfield v. Middle Tennessee State University (2021) tnmd “21 C.F.R. §50.1 , et seq. The regulation cited by Plaintiff, 21 C.”
Graw v. Eli Lilly and Company (2025) moed “1, 2023) (citing 21 C.F.R § 50.1); DeJean v. Kelly, No. 8:22-CV-0461-KKM-TGW, 2022 WL 3345329 , at *2 (M.”
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