Premarketing approval application (PMA)

From Glossary for Health Technology Lifecycle by EuroScan
Revision as of 11:37, 17 November 2023 by Editor iHTS (talk | contribs) (Created page with "An application made by the manufacturer to the Food and Drug Administration (FDA) for approval to market a medical product in the United States. '''Note:''' This application includes the pertinent information documenting the safety and effectiveness of the product. '''Alternative spellings:''' pre-market approval application, premarket approval application == Reference == http://htaglossary.net/premarketing-approval-application-(PMA)")

(diff) ← Older revision | Approved revision (diff) | Latest revision (diff) | Newer revision → (diff)

An application made by the manufacturer to the Food and Drug Administration (FDA) for approval to market a medical product in the United States.

Note: This application includes the pertinent information documenting the safety and effectiveness of the product.

Alternative spellings: pre-market approval application, premarket approval application

Reference

http://htaglossary.net/premarketing-approval-application-(PMA)

Retrieved from "http://glossary.i-hts.org/index.php?title=Premarketing_approval_application_(PMA)&oldid=533"