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Title 21Chapter ISubchapter HPart 812Subpart D → §812.66


Title 21: Food and Drugs
PART 812—INVESTIGATIONAL DEVICE EXEMPTIONS
Subpart D—IRB Review and Approval


§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).

[46 FR 8957, Jan. 27, 1981]

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