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21 CFR 814.80

§ 814.80 General.

United States · 21 CFR — Food and Drugs · Status: effective

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21 CFR 814.80, § 814.80 General, United States, version 1 as recorded 2026-07-09, yourstate.us, https://yourstate.us/provision/88871
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Full text

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.

Legislative history

This is a federal regulation, adopted through agency rulemaking under the Administrative Procedure Act — not enacted by a recorded vote of Congress.