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Code · CFR · Title 21 — Food and Drugs · Part 814 — Premarket Approval of Medical Devices · § 814.80

§ 814.80. General.

32 words·~1 min read·/us/cfr/t21/s§ 814.80·

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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.
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§ 814.80
General.
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