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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 Oct. 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)
Medical Device User Fee Stabilization Act of 2005
PDF (50 KB) |
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Fees
Forms
- User
Fees Cover Sheet
- MDUFMA
Stakeholder Letter [PDF 84 KB]
- FDA 3602 and 3602A— FY 2008 MDUFMA Small Business Qualification Worksheet and Certification
— Explains how you may qualify for fee discounts and waivers for submissions you make during FY 2008. PDF (240
KB)
Reports
FY 2006 MDUFMA Performance Report
PDF (387 KB)
FY 2006 MDUFMA Financial Report
PDF (265 KB)
Report Archives
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More MDUFMA Information
Other User Fee Information
Contacts
Documents in Portable Document Format (PDF) retain their original format. To view or print these documents, you must use the Adobe
Acrobat Reader, which is free and available directly from Adobe's Website with full installation instructions.
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