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Devices & Diagnostics Letter
Sept. 24, 2012 | Vol. 39 No. 38
Industry Praises PMA Acceptance Draft Guidance, With Some Reservations
The FDA’s draft guidance on the PMA acceptance process follows transparency and time goals outlined during recent FDA-industry Medical Device User Fee Act (MDUFA) negotiations and provides details that will help ensure a smooth and productive review, industry comments suggest.
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