{"data":{"id":"us/21-cfr-814.80","jurisdiction":"us","citation":"21 CFR 814.80","heading":"General.","body":"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.","path":["Title 21—Food and Drugs","CHAPTER I—FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES","SUBCHAPTER H—MEDICAL DEVICES","PART 814—PREMARKET APPROVAL OF MEDICAL DEVICES","Subpart E—Postapproval Requirements"],"source_url":"https://www.ecfr.gov/api/versioner/v1/full/2026-08-25/title-21.xml","current_through":"2026-08-25","vintage":"","retrieved_at":"2026-08-27T02:24:47Z","sha256":"b5a3306260ac177f099fde7037a84212c5075ba1b8b211fea69f4f96737df5ca","source_id":"us-cfr","stale":true,"prev":"us/21-cfr-814.47","next":"us/21-cfr-814.82"},"notice":"GroundRules: Original legal text. Not legal advice."}