GroundRules
21 CFR 814.80: General.
Where this section sits in the code
- 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
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.
Collected 2026-08-27T02:24:47Z. Source file · JSON