CFR 21-814.39-2014
Food and Drugs. Part814:Premarket approval of medical devices. Section814.39:PMA supplements.

Standard No.

CFR 21-814.39-2014

Release Date

2014

Published By

US-CFR-file

Latest

CFR 21-814.39-2014

Scope

(a) After FDA's approval of a PMA, an applicant shall submit a PMA supplement for review and approval by FDA before making a change affecting the safety or effectiveness of the device for which the applicant has an approved PMA, unless the change is of a

CFR 21-814.39-2014 history

• 2014 CFR 21-814.39-2014 Food and Drugs. Part814:Premarket approval of medical devices. Section814.39:PMA supplements.