MD+DI Online is part of the Informa Markets Division of Informa PLC

This site is operated by a business or businesses owned by Informa PLC and all copyright resides with them. Informa PLC's registered office is 5 Howick Place, London SW1P 1WG. Registered in England and Wales. Number 8860726.

Regulatory: Industry Sees Increased MDUFMA Activity, but Decisions are Still Slow


Last year, MD&DI used preliminary reports from MDUFMA to generate findings for its 2006 December issue. The MDUFMA reports released for FY 2006 confirmed those preliminary numbers and are reprinted in this section. CDRH did release its FY 2006 annual report, and therefore, data from that report regarding the Third-Party Review Program have been updated.

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 FY 2006 and 90% in FY 2007. 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 premarket approval applications and panel-track supplements. Source: FY 2006 MDFUMA Performance Report to Congress.

Fifty percent of PMAs received in FY 2007 are to have an FDA
decision within 180 days. Also, 25 goals will have higher performance levels for FY 2007, and two goals remain unchanged from FY 2006.
—FY 2006 MDUFMA Performance Report to Congress

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 2006 MDUFMA Financial Report.
FDA's goal is that 90% of PMA applications received in 2007 will have a decision in 320 days. In 2006, FDA made 19 decisions, but left 32 without a decision. Source: FY 2006 MDUFMA
Performance Report to Congress.
In 2006, FDA made determinations on 2503 of the 3913 510(k) applications received. For 510(k)s, FDA's goal is to decide on 80% of submissions in 2007. Source: FY 2006 MDUFMA Performance Report to Congress.
Number of medical device listings by medical specialty, with a percentage of total listings. Percentages are rounded to the nearest whole number. Source: CDRH database.

The MDUFMA cohort portion of 501(k) submissions represented more than 96% of total submissions in FY 2006.
—FY 2006 MDUFMA Performance Report to Congress

FDA's use of the Third-Party Inspection Program for 510(k) submissions in FY 2006 increased 18% over use of the program in FY 2005. Source: CDRH FY 2005 Highlights and CDRH FY 2006 Annual Report.
Copyright ©2007 Medical Device & Diagnostic Industry
Hide comments


  • Allowed HTML tags: <em> <strong> <blockquote> <br> <p>

Plain text

  • No HTML tags allowed.
  • Web page addresses and e-mail addresses turn into links automatically.
  • Lines and paragraphs break automatically.