21 C.F.R. § 812.66 Significant risk device determinations.
Title 21 - Food and Drugs
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). [46 FR 8957, Jan. 27, 1981]
Title 21: Food and Drugs
PART 812—INVESTIGATIONAL DEVICE EXEMPTIONS
Subpart D—IRB Review and Approval
§ 812.66 Significant risk device determinations.
