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Article: Medical device user fee performance goals detailed for 2003: 510(k) substantially equivalent devices, instruments, equipment & supplies to receive improved review times. (Breaking News).
- Article from:
- Biomedical Market Newsletter
- Article date:
- December 27, 2002
CopyrightCOPYRIGHT 2002 Biomedical Market Newsletter, Inc. This material is published under license from the publisher through the Gale Group, Farmington Hills, Michigan. All inquiries regarding rights should be directed to the Gale Group. (Hide copyright information)
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Details of the performance goals and procedures of the Medical Device User Fee & Modernization Act of 2002, "MDUFMA," which accompany the authorization for the fees, were released earlier this month to the industry and public.
These goals represent a "realistic projection" of what the US Food & Drug Administration's Center for Devices & Radiological Health and Center for Biologics Evaluation & Research can accomplish. Of course, these goals require industry cooperation and the additional resources specified in the new legislation.
Of key importance are specifications for 510(k) (substantially equivalent) medical devices, for which 75% of submissions ...