Home
gpo.gov
govinfo.gov

e-CFR Navigation Aids

Browse

Simple Search

Advanced Search

 — Boolean

 — Proximity

 

Search History

Search Tips

Corrections

Latest Updates

User Info

FAQs

Agency List

Incorporation By Reference

eCFR logo

Related Resources

Electronic Code of Federal Regulations

We invite you to try out our new beta eCFR site at https://ecfr.federalregister.gov. We???ve made big changes to make the eCFR easier to use. Be sure to leave feedback using the Help button on the bottom right of each page!

e-CFR data is current as of August 11, 2020

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.

return arrow Back to Top

§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]

return arrow Back to Top

§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]

return arrow Back to Top

§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]

return arrow Back to Top

§812.65   [Reserved]

return arrow Back to Top

§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]

return arrow Back to Top

Need assistance?