CDRH Adds MDUFMA Goal for 510(k)s But Not PMAs

Earlier this week, CDRH announced it will pursue an optional MDUFMA goal regarding 510(k)s but not one regarding PMAs. For fiscal year 2007, it aims to render a final decision for 80% of 510(k) applications within 90 days. It declined to set a goal of a final decision for 50% of PMA applicaitons within 180 days. AdvaMed and the Medical Device Manufacturers Association gave the news a lukewarm response. The docket for comments is open for about another month. Information about filing comments is available here.

May 25, 2006

1 Min Read
CDRH Adds MDUFMA Goal for 510(k)s But Not PMAs

Earlier this week, CDRH announced it will pursue an optional MDUFMA goal regarding 510(k)s but not one regarding PMAs. For fiscal year 2007, it aims to render a final decision for 80% of 510(k) applications within 90 days. It declined to set a goal of a final decision for 50% of PMA applicaitons within 180 days. AdvaMed and the Medical Device Manufacturers Association gave the news a lukewarm response. The docket for comments is open for about another month. Information about filing comments is available here.

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