FDAnews Device Daily Bulletin

Deficiency Letter, IDE Review Changes May Be Among MDUFA Gifts to Industry

Aug. 17, 2012
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Higher user fees and the FDA’s corresponding pledge to improve performance at CDRH stole the spotlight during the Medical Device User Fee Act (MDUFA) reauthorization process earlier this year. But a bevy of less-noted provisions in the law may offer significant benefits to devicemakers, experts say. For example, MDUFA III requires that major deficiency letters issued in response to PMAs be based on a review of the complete application, rather than the partial reviews some devicemakers have seen in the past, Steve Niedelman, lead quality systems and compliance expert at King & Spalding, said.
Devices & Diagnostics Letter