CFR 21-814.104-2014
Food and Drugs. Part814:Premarket approval of medical devices. Section814.104:Original applications.

Standard No.

CFR 21-814.104-2014

Release Date

2014

Published By

US-CFR-file

Latest

CFR 21-814.104-2014

Scope

(a) United States applicant or representative. The applicant or an authorized representative shall sign the HDE. If the applicant does not reside or have a place of business within the United States, the HDE shall be countersigned by an authorized repres

CFR 21-814.104-2014 history

• 2014 CFR 21-814.104-2014 Food and Drugs. Part814:Premarket approval of medical devices. Section814.104:Original applications.