Medical Devices
Medical Device User Fee and Modernization Act (MDUFMA)
NEWS: Medical Device User Fees Have Been Reauthorized for Fiscal Years 2008 - 2012 (September 28, 2007) - Includes Information on New FY 2010 Fees and Fee Rates
FY 2010 Small Business Guidance Now Available
FDA's "FY 2010 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 2010 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).
Action Dates
Meetings
- Agenda and Materials From April 20, 2010 FDA Performance Report
- 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
Comment on MDUFMA
About the MDUFMA and MDUFA
Medical Device User Fees Have Been Reauthorized for Fiscal Years 2008 - 2012 Medical Device Provisions of the Food and Drug Administration Amendments Act of 2007 (Preliminary) (PDF - 405KB)MDUFA 2007 Commitment Letter (PDF - 63KB)Summary of the Medical Device User Fee and Modernization Act of 2002 Summary of the Medical Devices Technical Corrections Act (MDTCA) Medical Device User Fee and Modernization Act of 2002 (MDUFMA), P.L. 107-250 Performance Goals For The Medical Device User Fee And Modernization Act Of 2002 -- (Senate - November 19, 2002) Background on MDUFMA All-Hands Notice from Dan Schultz about MDUFMA II (Issued April 16, 2007)
Contact Us
CDRH-Division of Small Manufacturers, International and Consumer Assistance (DSMICA)
- 1-800-638-2041
- 301-847-8149 (Fax)
- dsmica@fda.hhs.gov
Office of Communication, Education and Radiation Programs
Center for Devices and Radiological Health
Food and Drug Administration
10903 New Hampshire Avenue
WO66-4613
Silver Spring, MD 20993