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FDAnews Device Daily Bulletin
Aug. 7, 2012 | Vol. 9 No. 154
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A new draft guidance aims to expedite the device approval process by clarifying the reasons the FDA can reject a PMA during the acceptance and filing process. Filing review questions are now separated into “acceptance decision questions,” such as whether the file is complete from an administrative point of view, and “filing decision questions,” such as whether the data in the application is consistent with the protocol, device design and proposed indications.
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