Premarket Approval Application

 
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A PMA is a submission that is required for Class III medical devices. The requirements for the contents of a PMA are presented in 21 CFR § 814.20.




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Class III Device

A device is designated Class III that is not Class I or Class II because insufficient information exists to know whether either general controls or special controls are adequate to...

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Code of Federal Regulations: CFR

The CFR is the compilation of Federal regulations. 21 CFR contains the regulations that pertain to food, drugs, device, biologics and cosmetics....

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