21 C.F.R. § 814.80 : Food and Drugs — FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES — MEDICAL DEVICES — PREMARKET APPROVAL OF MEDICAL DEVICES — POSTAPPROVAL REQUIREMENTS — 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.