CFR 21-814.44-2014
Food and Drugs. Part814:Premarket approval of medical devices. Section814.44:Procedures for review of a PMA.

Standard No.

CFR 21-814.44-2014

Release Date

2014

Published By

US-CFR-file

Latest

CFR 21-814.44-2014

Scope

(a) FDA will begin substantive review of a PMA after the PMA is accepted for filing under § 814.42. FDA may refer the PMA to a panel on its own initiative, and will do so upon request of an applicant, unless FDA determines that the application substantial

CFR 21-814.44-2014 history

• 2014 CFR 21-814.44-2014 Food and Drugs. Part814:Premarket approval of medical devices. Section814.44:Procedures for review of a PMA.