FDAnews Device Daily Bulletin

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

Aug. 17, 2012
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