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.