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Industry Praises PMA Acceptance Draft Guidance, With Some Reservations

The FDA’s draft guidance on the PMA acceptance process follows transparency and time goals outlined during recent FDA-industry Medical Device User Fee Act (MDUFA) negotiations and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. The proposed guidance accurately reflects the spirit of the MDUFA commitment letter, wrote Johnson & Johnson (J&J) Vice President of Regulatory Affairs Minnie Baylor-Henry.
Devices & Diagnostics Letter