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(MDUFMA Logo)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 2009 Fees and Fee Rates

FY 2009 Small Business Guidance Now Available

FDA's "FY 2009 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 2009 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).


About the MDUFMA and MDUFA

Action Dates

Federal Register

 

Fees

Forms

MDUFMA Guidance Documents

MDUFMA Presentations

  • Agenda and Materials From October 30, 2008 FDA Performance Report [Text] [PDF]
  • Agenda and Materials From July 30 FDA Performance Report [PDF]

Frequently Asked Questions

Reports

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

 

Report to Congress: Labeling Information on the Relationship Between the Use of Indoor Tanning Devices and Development of Skin Cancer or Other Skin Damage
[Text] [PDF]

Agenda and Materials From October 30, 2008 FDA Performance Report [Text] [PDF]

Agenda and Materials From July 30 FDA Performance Report [PDF]

Medical Device User Fees Have Been Reauthorized for Fiscal Years 2008 - 2012 (September 28, 2007) [Text]

All-Hands Notice from Dan Schultz about MDUFMA II (April 16, 2007) [Text]

New Guidance

FY 2009 Medical Device Small Business Qualification and Certification

Interactive Review for Medical Device Submissions: 510(k)s, Original PMAs, PMA Supplements, Original BLAs, and BLA Supplements - Describes the roles of both FDA and industry in an interactive review process of specific medical device submission types.

Information Related to MDUFMA II

Information Related to the MDUFMA FY 2007 180-Day PMA Goal [Text] [PDF]

New Reports

FY 2006 MDUFMA Financial Report [Text] [PDF]

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]

MDUFMA Guidances

Contact Us

Comment on MDUFMA

Updated December 19, 2008

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