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 2012 User Fee Letter Now Available

• Important Information on the Medical Device User Fee Rates for FY2012

FY 2012 Small Business Guidance Now Available

FDA's "FY 2012 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 2012 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 2012 Medical Device Small Business Qualification and Certification (PDF - 336kb)

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

Related Resources

• Office of Combination Products
• Pediatric Devices

Comment on MDUFMA

• Public Docket for Comments