FDA Report: MDUFMA Reforms Sped Up PMA Reviews

The Office of Device Evaluation annual report released Monday shows that CDRH was much faster in reviewing PMAs in fiscal year 2006 than in FY 2005, Reuters reports. The report attributed the improvement -- PMA reviews dropped from an average of 438 days in FY '05 to an average of 335 days in FY '06 -- to reforms implemented from the Medical Device User Fee and Modernization Act of 2002.

June 24, 2008

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FDA Report: MDUFMA Reforms Sped Up PMA Reviews

Statistics for FY 2007 are not yet available.However, average 510(k) review time rose slightly, from 87 days in FY '05 to 95 days in FY '06. And the report also noted that third-party reviews dropped in 2007, compared to 2006. That was before reforms to the program included in the FDA Amendments Act of 2007 were implemented, though.

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