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


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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 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				Fees FY 2005 User Fee Summary Device User Fee Rates for Fiscal Year 2005 Federal Register Aug. 2, 2004 PDF 60 KB Device User Fees for FY 2004 Talk Paper Slide Presentation Federal Register Notice FY 2003 Fee Payment Instructions (PDF 51.5 KB) Overview of Payment Procedures/Rates for Fiscal Year 2003 (Federal Register Feb. 25, 2003) (PDF 42.5 KB) Payment Procedures Broadcast / Webcast (April 9, 2003) How will fees be submitted, waivers, more... Forms User Fees Cover Sheet FDA 3602 - FY2004 MDUFMA Small Business Qualification Certification (PDF 423 KB) Guidance Guidance for Industry and FDA: FY 2005 MDUFMA Small Business Qualification Worksheet and Certification Expedited Review of Premarket Submissions for Devices User Fees and Refunds for Premarket Approval Applications Bundling Multiple Devices or Multiple Indications in a Single Submission Premarket Approval Application Modular Review (PDF 81.2 KB) FY 2004 MDUFMA Small Business Qualification Worksheet and Certification - Guidance for Industry and FDA (PDF 183 KB) Premarket Assessment of Pediatric Medical Devices - Draft Guidance for Industry and FDA Staff (PDF 82.9 KB) Validation Data in Premarket Notification Submissions (510(k)s) for Reprocessed Single-Use Medical Devices (PDF 82.4 KB) Compliance with Section 301 of MDUFMA Ò Identification of Manufacturer of Medical Devices (PDF 29.8 KB) Accreditation Criteria Guidance (PDF 112 KB)			What's New: FY 2005 User Fee Summary Second Annual Stakeholders Meeting -- Nov. 18, 2004 Closest Action Dates: 11/30 12/31 Complete List of Action Dates (PDF 74.8 KB) Comment on MDUFMA (Docket #: 02N-0534) Contacts: Billing Issues Comments/Suggestions for the MDUFMA Website Other User Fee Information: Rx Drugs User Fees and Medical Device Reviews (FDA Consumer article) User Fees for Faster Drug Reviews (FDA Consumer article) Myths About Drug Withdrawals and User Fees (FDA Consumer article) Report to Congress 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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