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) > 812.62—IRB 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.

Code of Federal Regulations

[46 FR 8957, Jan. 27, 1981]