Title 21: Food and Drugs
« Home / Title 21 - Food and Drugs--Volume 8 / CHAPTER I - FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) / SUBCHAPTER H - MEDICAL DEVICES
/ PART 814 - PREMARKET APPROVAL OF MEDICAL DEVICES
/ Subpart E - Postapproval Requirements / § 814.80 General.
§ 814.80 General.
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.