Regulatory: Alphabet Soup: MDUFMA, PMAs, and 510(k)sRegulatory: Alphabet Soup: MDUFMA, PMAs, and 510(k)s

Fees collected as a percentage of program cost. User fees as specified in MDUFMA are not cost-based, and the user fee is a relatively small supplement to, rather than a replacement for, appropriations. Source: FDA Unit Costs for the Process of Medical Device Review.

Medical device manufacturing, repackaging, and rebuilding operations, by state. Source: CDRH establishment registration database.

Office of Regulatory Affairs (ORA) costs for the process of the review of device applications. The costs include total process costs, including costs paid from appropriations and fee revenues. Source: FDA Unit Costs for the Process of Medical Device Review.

CDRH distribution of costs for general support functions for reviews. Source: FDA Unit Costs for the Process of Medical Device Review.

Average review time for original premarket approval (PMA) applications increased from 221 days in 2003 to 285 in 2004. Non-FDA approvals increased from 70 days to 143 days. Source: ODE annual report.

The increase in the number of 510(k) submissions reviewed by third parties can be attributed to FDA's implementation of MDUFMA's user-fee provisions during FY 2003. The provisions required applicants to pay a fee when submitting 510(k)s without a third-party review. Source: ODE annual report.