[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: 21CFR812.42]



[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 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]