[Code of Federal Regulations]

[Title 21, Volume 8]

[Revised as of April 1, 2006]

From the U.S. Government Printing Office via GPO Access

[CITE: 21CFR812.62]



[Page 111]

 

                        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]