21 CFR 814.80 - General.

Regulations last checked for updates: May 01, 2025

Title 21 - Food and Drugs last revised: Apr 28, 2025

View all text of Subpart E [§ 814.80 - § 814.84]

§ 814.80 - General.

A device may not be manufactured, packaged, stored, labeled, distributed, or advertised in a manner that is inconsistent with any conditions to approval specified in the PMA approval order for the device.

authority: 21 U.S.C. 351,352,353,360,360c-360j,360bbb-8b,371,372,373,374,375,379,379e,379k-1,381

source: 51 FR 26364, July 22, 1986, unless otherwise noted.

cite as: 21 CFR 814.80