US lawFederal (United States)RegulationsTitle 21 CFR — Food and DrugsChapter I — FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICESPart 814 — PREMARKET APPROVAL OF MEDICAL DEVICESSubpart E — Postapproval Requirements814.8021 C.F.R. § 814.80General.Last amended: 2016Year: 2026Length: 32 wordsOfficial source Cite as 21 C.F.R. § 814.80 (2026)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.Next21 C.F.R. § 814.82