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.
21 CFR Part 814 · Premarket Approval of Medical Devices
§ 814.80 General
Independent copy, not an official legal edition. 21 CFR is a U.S. Government work in the public domain; this text comes from the eCFR and the annual CFR edition, and may lag recent amendments. The authoritative version is on ecfr.gov. Compliome is not affiliated with or endorsed by FDA. Not legal advice.
Warning letters citing § 814.80
1 FDA warning letters since 2017 cite this section :
- Ocular Therapeutix Inc. 17 Oct 2018
Amendment history
Federal Register documents that created or amended this section.
- 51 FR 26364 22 Jul 1986