[Code of Federal Regulations]
[Title 21, Volume 8]
[Revised as of April 1, 2001]
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]