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Electronic Code of Federal Regulations

e-CFR data is current as of November 14, 2019

Title 21Chapter ISubchapter HPart 812 → Subpart D


Title 21: Food and Drugs
PART 812—INVESTIGATIONAL DEVICE EXEMPTIONS


Subpart D—IRB Review and Approval


Contents
§812.60   IRB composition, duties, and functions.
§812.62   IRB approval.
§812.64   IRB's continuing review.
§812.65   [Reserved]
§812.66   Significant risk device determinations.

§812.60   IRB composition, duties, and functions.

An IRB reviewing and approving investigations under this part shall comply with the requirements of part 56 in all respects, including its composition, duties, and functions.

[46 FR 8957, Jan. 27, 1981]

§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]

§812.64   IRB's continuing review.

The IRB shall conduct its continuing review of an investigation in accordance with part 56.

[46 FR 8957, Jan. 27, 1981]

§812.65   [Reserved]

§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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