[Code of Federal Regulations]
[Title 21, Volume 1]
[Revised as of April 1, 2002]
From the U.S. Government Printing Office via GPO Access
[CITE: 21CFR50.1]

[Page 285-286]
 
                        TITLE 21--FOOD AND DRUGS
 
CHAPTER I--FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN 
                                SERVICES
 
PART 50--PROTECTION OF HUMAN SUBJECTS--Table of Contents
 
                      Subpart A--General Provisions
 
Sec. 50.1  Scope.


    (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

[[Page 286]]

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]