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Home » FDA Releases MDUFA V Final Guidances for 510(k), PMA and De Novo Submissions
FDA Releases MDUFA V Final Guidances for 510(k), PMA and De Novo Submissions
The FDA has released three final guidances spelling out its product review goals and timing under user fee commitments negotiated with industry for the Medical Device User Fee Amendments (MDUFA) program reauthorized by Congress on Sept. 30.
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