[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: 21CFR812.66]



[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.  812.66  Significant risk device determinations.



    If an IRB determines that an investigation, presented for approval 

under Sec.  812.2(b)(1)(ii), involves a significant risk device, it 

shall so notify the investigator and, where appropriate, the sponsor. A 

sponsor may not begin the investigation except as provided in Sec.  

812.30(a).



[46 FR 8957, Jan. 27, 1981]