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.