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Medical Device User Fee and Modernization Act (MDUFMA) of 2002

About 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 premarket reviews.
• Establishment inspections may be conducted by accredited persons (third-parties),
• New regulatory requirements for reprocessed single-use devices.

• Summary of Law (PDF)
• Full Text of Law (PDF)
• Legislative History of MDUFMA
  • H.R. 5651 (the bill that was enacted) and
  • H.R. 3580 (H.R. 5651 built on this bill).
• Performance Goals (Congressional Record) (PDF)
• Performance Reports
  • First Quarter FY 04
  • Second Quarter FY 04 [PowerPoint] [Text]

Action Dates

• Actions and Reports with a Due Date Specified by the Medical Device User Fee and Modernization Act of 2002 or by Regulations and Notices Issued to Implement MDUFMA (PDF)

Federal Register

• Second Annual Stakeholder Meeting on the Implementation of the Medical Device User Fee and Modernization Act of 2002 Provisions; Public Meeting (September 28, 2004)
   
• Establishment of Medical Device User Fee Rates for Fiscal Year 2005 (August 2, 2004)

• Possible Barriers to the Availability of Medical Devices Intended to Treat or Diagnose Diseases and Conditions that Affect Children; Request for Comments (June 21, 2004)

• Establishment of Medical Device User Fee (MDUFA) Rates for Fiscal Year 2004 (August 1, 2003)

• Medical Devices; Reprocessed Single-Use Devices; Termination of Exemptions From Premarket Notification; Requirement for Submission of Validation Data (June 26, 2003)
   
• Final Rule: Assignment of Agency Component for Review of Premarket
  Applications (June 23, 2003)
  
• Reprocessed Single-Use Devices; Termination of Exemptions From Premarket Notification; Requirement for Submission of Validation Data (PDF) (April 30, 2003)
  
• Proposed Collection; Comment Request; Medical Device User Fee Cover Sheet; Form FDA 3601 (PDF) (Fed. 26, 2003)
  
• Medical Device User Fee Payment Procedures (PDF) (Feb. 25, 2003)
   
• Medical Device User Fee and Modernization Act of 2002; Establishment of a Public Docket (PDF) (Feb. 4, 2003)
   
• Establishment of Medical Device User Fee Rates for Fiscal Year 2003 and Interim Procedures (PDF)
  ( Nov. 21, 2002)

• Complete list of MDUFMA related Federal Register Announcements. (PDF) (Sep. 9, 2004)

Fees

• FY 2005 User Fee Summary [Text] [PDF]
• FDA Announces Device User Fees for FY 2004
• Fee Payment Instructions [PDF]
• Premarket Notification 510(k) fees
• Premarket Approval fees

Forms

• User Fees Cover Sheet
• FDA 3602 - FY2004 MDUFMA Small Business Qualification Certification [PDF] [Guidance]
• FDA 3602 - FY2005 MDUFMA Small Business Qualification Certification - Available in the PDF edition of the FY 2005 guidance document (not available separately): [PDF]
• Instructional webcast, "How Do I Create and Submit a User Fee Cover Sheet?" (originally broadcast 4/9/03)

MDUFMA Guidance Documents

• Guidance
• Blue Book Memos

MDUFMA Presentations

• Presentations

Frequently Asked Questions

• What is it?
• How do I obtain additional information?
• User Fees
• Third-Party Inspections
• Reprocessed Single-Use Devices
• Postmarket Surveillance
• Reducing Device Approval Times Goal

Reports

• August 2004 GAO report discusses FDA's progress towards achieving MDUFMA's performance goals [PDF]

Meetings

• 2^nd Annual MDUFMA Stakeholder Meeting
  Thursday, November 18, 2004
• 1st Annual Stakeholder Meeting on the Implementation of (MDUFMA)
  December 3, 2003

Related Resources

• Office of Combination Products
• Pediatric Devices

MDUFMA Webcasts

• Device User Fee Billing Procedures
  View Webcast (originally broadcast 4/9/03)

Contact Us

• CDRH Contacts for Specific Billing Issues
• 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.

Comment on MDUFMA

• Public Docket for Comments