MDUFMA/MDUFSA

MDUFMA/MDUFSA

Summary of the Medical Device User Fee and Modernization Act (MDUFMA) of 2002 and Medical Device User Fee Stabilization Act (MDUFSA) of 2005 Reprocessing Provisions

The Medical Device User Fee and Modernization Act of 2002 (MDUFMA), and Medical Device User Fee Stabilization Act of 2005 were signed into law on October 26, 2002, and August 1, 2005, respectively.[1] Although reprocessors of “single-use” devices (SUDs) were already subject to the same regulatory requirements as original equipment manufacturers (OEMs), intense pressure from OEMs led to the inclusion of provisions in MDUFMA and MDUFSA that add additional regulatory requirements for reprocessors. Although there was no public health rationale for the increased regulation, AMDR ultimately worked with Congress, the Food and Drug Administration (FDA), hospitals, and OEMs to develop the provisions described below. The highest priority of AMDR’s members is patient safety, and we take every step necessary to ensure the safety and effectiveness of reprocessed devices.

For FDA’s MDUFMA web-site, please click here.


[1] Medical Device User Fee and Modernization Act of 2002, Pub. L. No. 107-250, 116 Stat. 1588 (codified as amended in scattered sections of 21 U.S.C) [hereinafter MDUFMA]; Medical Device User Fee Stabilization Act of 2005, Pub. L. No. 109-43, 119. Stat. 439 (codified as amended in 21 U.S.C. 352(u) [hereinafter MDUFSA].)