CFR 21-814.116-2014
Food and Drugs. Part814:Premarket approval of medical devices. Section814.116:Procedures for review of an HDE.

Standard No.

CFR 21-814.116-2014

Release Date

2014

Published By

US-CFR-file

Latest

CFR 21-814.116-2014

Scope

(a) Substantive review. FDA will begin substantive review of an HDE after the HDE is accepted for filing under § 814.112. FDA may refer an original HDE application to a panel on its own initiative, and shall do so upon the request of an applicant, unless

CFR 21-814.116-2014 history

• 2014 CFR 21-814.116-2014 Food and Drugs. Part814:Premarket approval of medical devices. Section814.116:Procedures for review of an HDE.