Premarket Approval (PMA) - US Food and Drug Administration
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Premarket approval (PMA) is the FDA process of scientific and regulatory review to evaluate the safety and effectiveness of Class III medical devices. Class III ... QuickLinks:Skiptomainpagecontent SkiptoSearch SkiptoTopicsMenu SkiptoCommonLinks
延伸文章資訊
- 1Search Registration and Listing | FDA
The database is updated weekly, usually every Monday. To search: Enter information in one or more...
- 2Drugs@FDA: FDA-Approved Drugs
Drugs@FDA: FDA-Approved Drugs · Search by Drug Name, Active Ingredient, or Application Number* · ...
- 3Device Approvals, Denials and Clearances | FDA
510(k) (premarket notification) to FDA is required at least 90 days before marketing unless the d...
- 4Medical Device Databases | FDA
Manufacturers required to conduct PAS must complete the study as a condition of approval. This da...
- 5Drug Approvals and Databases | FDA
Additional topics include: approved REMS, drug shortages, and the Orange ... Inactive Ingredient ...
