[Code of Federal Regulations]
[Title 21, Volume 8]
[Revised as of April 1, 2004]
From the U.S. Government Printing Office via GPO Access
[CITE: 21CFR812.62]

[Page 110]
 
                        TITLE 21--FOOD AND DRUGS
 
CHAPTER I--FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN 
                          SERVICES (CONTINUED)
 
PART 812_INVESTIGATIONAL DEVICE EXEMPTIONS--Table of Contents
 
                    Subpart D_IRB Review and Approval
 
Sec. 812.62  IRB approval.

    (a) An IRB shall review and have authority to approve, require 
modifications in (to secure approval), or disapprove all investigations 
covered by this part.
    (b) If no IRB exists or if FDA finds that an IRB's review is 
inadequate, a sponsor may submit an application to FDA.

[46 FR 8957, Jan. 27, 1981]

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