[Code of Federal Regulations]
[Title 21, Volume 8]
[Revised as of April 1, 2003]
From the U.S. Government Printing Office via GPO Access
[CITE: 21CFR812.42]

[Page 109]
 
                        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 C--Responsibilities of Sponsors
 
Sec. 812.42  FDA and IRB approval.

    A sponsor shall not begin an investigation or part of an 
investigation until an IRB and FDA have both approved the application or 
supplemental application relating to the investigation or part of an 
investigation.

[46 FR 8957, Jan. 27, 1981]