---
kind: "section"
citation: "21 C.F.R. § 814.80"
title: "21"
number: "814.80"
heading: "General."
url: "https://uscodex.org/cfr/21/814.80"
---

# §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.


## Notes

### Authority

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

### Source

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