[Code of Federal Regulations]
[Title 21, Volume 1]
[Revised as of April 1, 2007]
From the U.S. Government Printing Office via GPO Access
[CITE: 21CFR56.101]
[Page 294]
TITLE 21--FOOD AND DRUGS
CHAPTER I--FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN
SERVICES
PART 56 INSTITUTIONAL REVIEW BOARDS--Table of Contents
Subpart A General Provisions
Sec. 56.101 Scope.
(a) This part contains the general standards for the composition,
operation, and responsibility of an Institutional Review Board (IRB)
that reviews clinical investigations regulated by the Food and Drug
Administration under sections 505(i) and 520(g) of the 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. Compliance
with this part is intended to protect the rights and welfare of human
subjects involved in such investigations.
(b) References in this part to regulatory sections of the Code of
Federal Regulations are to chapter I of title 21, unless otherwise
noted.
[46 FR 8975, Jan. 27, 1981, as amended at 64 FR 399, Jan. 5, 1999; 66 FR
20599, Apr. 24, 2001]
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