21 C.F.R. § 814.80 General.
Title 21 - Food and Drugs
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.
Title 21: Food and Drugs
PART 814—PREMARKET APPROVAL OF MEDICAL DEVICES
Subpart E—Postapproval Requirements
§ 814.80 General.
