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

NEWS: Medical Device User Fees Have Been Reauthorized for Fiscal Years 2008 - 2012 (September 28, 2007) - Includes Information on New FY 2008 Fees and Fee Rates

FY 2008 Small Business Guidance Now Available

FDA's "FY 2008 Medical Device User Fee Small Business Qualification and Certification" guidance is now available. This guidance explains how your business may qualify as a “small business” and pay most FY 2008 medical device user fees at substantially discounted rates; if you qualify as a small business, you may also qualify to obtain a one-time waiver of the fee for your first (ever) premarket application (premarket approval application, biologics license application, product development protocol, or premarket report).

• FY 2008 Medical Device Small Business Qualification and Certification

About the MDUFMA and MDUFA

• Medical Device User Fees Have Been Reauthorized for Fiscal Years 2008 - 2012 (Issued September 28, 2007)
• Medical Device Provisions of the Food and Drug Administration Amendments Act of 2007 (Preliminary) (PDF)
• MDUFA 2007 Commitment Letter (PDF)
• FAQs on the New Establishment Registration Fee
• Summary of MDUFMA 2002 (PDF)
• Summary of MDTCA (PDF)
• Full Text of MDUFMA 2002 (PDF)
• MDUFMA 2002 Performance Goals (Congressional Record) (PDF)
• Performance Reports
• Background on MDUFMA
• All-Hands Notice from Dan Schultz about MDUFMA II (Issued April 16, 2007)

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

• Medical Device User Fee and Modernization Act; Notice to Public of Web Location of 2008 Proposed Guidance Development; Establishment of a Public Docket (October 10, 2007)
   
• Medical Devic User Fee and Modernization Act; Public Meeting (September 29, 2005)
   
• Medical Devices; Reprocessed Single-Use Devices; Termination of Exemptions from Premarket Notification; Requirement for Submission of Validation Data (September 29, 2005)

• Medical Devices; Reprocessed Single-Use Devices; Termination of Exemptions From Premarket Notification; Requirement for Submission of Validation Data (June 26, 2003)
  
• Reprocessed Single-Use Devices; Termination of Exemptions From Premarket Notification; Requirement for Submission of Validation Data (PDF) (April 30, 2003)
   
• Medical Device User Fee and Modernization Act of 2002; Establishment of a Public Docket (PDF) (Feb. 4, 2003)

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

Fees

• FY08 User Fee Letter [Text] [PDF]
• Questions and answers on the new establishment registration fee. Includes an explanation of which establishments have to pay the fee, provides payment instructions, and explains how to obtain additional information and help.
• Premarket Notification 510(k) fees
• Premarket Approval fees

Forms

• Certification to Accompany Drug, Biological Product, and Device Applications or Submissions
• User Fees Cover Sheet
• Forms FDA 3602 and FDA 3602A are available in FDA's guidance, FY 2008 Medical Device Small Business Qualification and Certification.

MDUFMA Guidance Documents

• Guidance
• Documents CDRH is Considering for Development (FY08)
• 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

Reports

• Latest Quarterly Update on FDA Progress Towards Achieving MDUFMA Performance Goals (actions through Sept. 30, 2006) [PDF]
• Latest Quarterly Report on Progress Towards Achieving MDUFMA Performance Goals (actions through Sept. 30, 2006) [PDF]
• FY2003-2004 Device Cost Analysis Report
• FY 2004 MDUFMA Financial Report
• FY 2006 MDUFMA Financial Report
• August 2004 GAO report discusses FDA's progress towards achieving MDUFMA's performance goals [PDF]

Meetings

• Meeting to Discuss the Possible Implementation of Two Review Performance Goals in the Medical Device User Fee and Modernization Act of 2002
  Monday, May 22, 2006

Related Resources

• Office of Combination Products
• Pediatric Devices

Contact Us

• 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