1. LawStack
  2. Title 21 - Food and Drugs
  3. Chapter I - FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES
  4. Subchapter H - MEDICAL DEVICES
  5. Part 814 - PREMARKET APPROVAL OF MEDICAL DEVICES
  6. Subpart E - Postapproval Requirements
  7. 21 CFR § 814.80
21 CFR § 814.80
General
June 25, 2020
CFR

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.

Next
§ 814.82 Postapproval requirements

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