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2nd Annual Stakeholder Meeting on the Implementation of the Medical Device User Fee and Modernization Act of 2002 (MDUFMA)

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The Food and Drug Administration is announcing a public meeting to discuss the agency’s progress in implementing the various MDUFMA provisions, including the guidances FDA has issued on the new law.

Date:

Thursday, November 18, 2004

Time:
9 AM to 5 PM
Location:

Marriott Gaithersburg Washingtonian Center
9751 Washingtonian Blvd.
Gaithersburg, MD 20878
(301) 590-0044

www.marriott.com

Registration:
Online registration by November 5, 2004 is required for this meeting. Acceptance will be on a first-come first-served basis. There will be no onsite registration. You may register to attend the meeting in person, or to listen to the meeting as an audioconference by phone..
Additional Information:

Topics to be discussed are:

  • User Fees Process
  • Premarket Review Performance Goals
  • Qualitative Performance Goals(e.g. Modular PMA and GMP and Bioresearch Monitoring (BIMO) Inspection Programs)
  • Third-Party Inspection Program
  • Reuse

Additional information regarding agenda items can be found in the Federal Register announcment.

Back to MDUFMA Home Page

Updated October 27, 2004

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