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Home > Newsletters > Devices & Diagnostics Letter > New Draft PMA Filing Guidance Outlines Rejection Rules

Devices & Diagnostics Letter

Aug. 6, 2012 | Vol. 39 No. 31

New Draft PMA Filing Guidance Outlines Rejection Rules

A new draft guidance aims to expedite the device approval process by clarifying the reasons the FDA can reject a PMA during the acceptance and filing process.

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