[Code of Federal Regulations]
[Title 21, Volume 1]
[Revised as of April 1, 2001]
From the U.S. Government Printing Office via GPO Access
[CITE: 21CFR50.1]

[Page 283]
 
                        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 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 406, 409, 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]