The Act
The Medical Device User Fee and Modernization Act of 2002 (MDUFMA), P.L. 107-250, amends the Federal Food, Drug, and Cosmetic Act to provide FDA important new responsibilities, resources, and challenges. MDUFMA was signed into law October 26, 2002. MDUFMA has three particularly significant provisions:
- User fees for device reviews.
- Establishment inspections may be conducted by accredited persons (third-parties),
- New regulatory requirements for reprocessed single-use devices.
Summary of the Law (PDF 67.6 KB)
Complete Text of the Law (PDF 172 KB)
Bill Summary
Performance Goals (PDF 72.2 KB)
Background Information
What is MDUFMA?
MDUFMA Slide Presentation
(Text only) (PDF 84 KB)
Third Party Inspections
Reprocessed Single-Use Devices
Postmarket Surveillance
Meetings
Second Annual Stakeholders Meeting -- Nov. 18, 2004
First Annual Stakeholders Meeting -- Dec. 3, 2003
Reports
FY 2003 MDUFMA
Performance Report (PDF 606
KB)
Presentation: MDUFMA Second Quarter FY 04 Report
FY 2003 MDUFMA Financial Report (PDF 270 KB)
MDUFMA First Quarter FY 2004 Report
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