Medical Device User Fee and Modernization Act of 2002

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)

Fees

• Medical Device User Fee Rates for Fiscal Year 2008 (Federal Register, Oct. 12, 2007)
  PDF (62 KB)
• User fee rate notices from previous years

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 2007 MDUFMA Performance Report
PDF (558 KB)

FY 2007 MDUFMA Financial Report
PDF (269 KB)

Report Archives

More MDUFMA Information

• Center for Devices and Radiological Health

Other User Fee Information

• Animal Drugs
• Human Drugs
• All User Fees

Contacts

• The Division of Small Manufacturers, International and Consumer Assistance (DSMICA) can answer basic questions concerning the new law, and help you find guidance documents and other reference materials.

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