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Electronic Code of Federal Regulations

e-CFR data is current as of November 12, 2019

Title 21Chapter ISubchapter HPart 812Subpart D → §812.62


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


§812.62   IRB approval.

(a) An IRB shall review and have authority to approve, require modifications in (to secure approval), or disapprove all investigations covered by this part.

(b) If no IRB exists or if FDA finds that an IRB's review is inadequate, a sponsor may submit an application to FDA.

[46 FR 8957, Jan. 27, 1981]

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