21 C.F.R. § 814.80
21 C.F.R. § 814.80
US-DOC-26754433
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Code of Federal Regulations
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21 C.F.R. § 814.80
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United States
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Federal
§ 814.80 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.