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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%.

Click images and tables to enlarge:

FDA actions on PMA applications and panel-track supplements. Figures for 2006 are through September 2006. FDA expects to meet the goal for 2006. Source: FDA Quarterly Update on Progress Towards Meeting MDUFMA Performance Goals.

 
Of the 24 quantifiable [MDUFMA] goals that were in effect for the FY 2003–2005 cohorts, FDA to date is meeting or exceeding 18 goals and is not meeting three goals. The three remaining goals have not yet had any action to measure.
—FY 2005 MDUFMA Report

Total cost ($) of the process for device application reviews. Usually, more than 81% of the obligated amounts are expended within one year, and 96% within two years. Source: FY 2005 MDUFMA Financial Report.
FDA's goal is that 80% of PMA applications received in 2006 will have a decision in 320 days. In 2006 to date, FDA made 19 decisions, but left 32 without a decision. Source: ODE Quarterly Summary Report.
In 2006 to date, FDA made determinations on 2503 of the 3913 510(k) applications received. For 510(k)s, FDA's goals are to
decide on 75% of submissions in 2005 and 2006. Source: ODE Quarterly Summary Report.
Medical device manufacturing, repackaging, and rebuilding operations, by state. Source: CDRH establishment registration database.








FDA increased the use of the third-party review program for 510(k) submissions. The program realized a 27% increase since FY 2003, when the agency implemented MDUFMA's user-fee
provisions. Source: CDRH FY 2005 Highlights.
Copyright ©2006 Medical Device & Diagnostic Industry
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