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

Originally Published MDDI December 2005   2005 MEDTECH SNAPSHOT  

Originally Published MDDI December 2005



The dramatic increases in the user fees mandated by the Medical Device User Fee and Modernization Act of 2002 (MDUFMA) have sparked much discussion and controversy during the last few years. In response, FDA prepared a report that examines the unit costs of the agency's medical device review process. The unit costs are, in effect, the average costs for FDA to review various types of applications during a particular period of time.

Other user-fee programs, such as the Prescription and Animal Drug User Fee Programs, differ from MDUFMA significantly, according to the report. Those user-fee pricing mechanisms have resulted in lower fees per application because the majority of fee revenue is collected from other mechanisms, including manufacturing establishments and product and sponsor fees. MDUFMA user fees, however, are derived solely from applications.

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.

Copyright ©2005 Medical Device & Diagnostic Industry

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