21 CFR 814.80 : Food And Drugs (§ 1.1 To Parts 1403-1499) — (Subpart A To Parts 1272-1299) — Food And Drug Administration, Department Of Health And Human Services (Continued) (Subpart A To Parts 1272-1299) — Medical Devices (Subpart A To § 898.14) — Premarket Approval Of Medical Devices (§ 814.1 To § 814.126) — Postapproval Requirements (§ 814.80 To § 814.84) — General.

4 Aug 2016

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.

21 CFR 814.80