Regulatory: New Goals for MDUFMA Submissions Change the Approval Game

2006 MEDTECH SNAPSHOT

Because FDA has changed its goals with regard to complying with MDUFMA, some information on this page does not correlate with previous years. For premarket approvals (PMAs), cycle goals apply to 75% of submissions received in FY 2005, 80% of those received in 2006, and 90% of submissions in 2007. FDA's goals state that it will make decisions on 80% of PMAs received in 2006.

Likewise, premarket notifications (510(k)s) have a new organization that makes it difficult to compare them with previous years. FDA has said it will have a decision for 75% of submissions received in FY 2005 and FY 2006. For FY 2005, FDA plans to apply these goals to 70% of the submissions. In 2006, it will include 80% of those submissions, and in 2007 the goals will apply to 90%.

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