CFR > Title 21 - Food and Drugs > CHAPTER I—FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES > SUBCHAPTER H—MEDICAL DEVICES (parts 800 to 898) > PART 812—INVESTIGATIONAL DEVICE EXEMPTIONS > SUBPART D—IRB Review and Approval (§812.60 to §812.66) > 812.66—Significant risk device determinations.

812.66—Significant risk device determinations.

If an IRB determines that an investigation, presented for approval under § 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 § 812.30(a).

Code of Federal Regulations

[46 FR 8957, Jan. 27, 1981]