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PMA Pre-Marketing Approval

Health Care Term

Pre-Marketing Approval -FDA approval classification for a medical device that is not substantially equivalent to a legally marketed device or is otherwise required by statute to have an approved application. Rapid HIV tests must have an approved PMA application before marketing of such a product can begin.

   
     

PMA Pre-Marketing Approval

Health Care Term

Pre-Marketing Approval -FDA approval classification for a medical device that is not substantially equivalent to a legally marketed device or is otherwise required by statute to have an approved application. Rapid HIV tests must have an approved PMA application before marketing of such a product can begin.

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