21 CFR § 814.80 Premarket Approval of Medical Devices

§ 814.80 General.

Current through Sep 8, 2026 · Read all of Part 814

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.

← § 814.47 Temporary suspension of approval of a PMA.§ 814.82 Postapproval requirements. →