Stakeholder Meeting to Discuss the Possible Implementation of Two Review Performance Goals Referenced in the Medical Device User Fee and Modernization Act of 2002; Public Meeting

Streszczenie

The Food and Drug Administration (FDA) is announcing the following public meeting: Stakeholder Meeting to Discuss the Possible Implementation of Two Review Performance Goals referenced in the Medical Device User Fee and Modernization Act of 2002 (MDUFMA). In a letter that accompanied the user fee legislation, the agency committed to a number of review performance goals. These goals include a commitment that 50 percent of the premarket approval applications received in fiscal year (FY) 2007 will have an FDA decision in 180 days and 80 percent of the premarket notifications will have an FDA decision in 90 days. The letter states that these goals are to be re-evaluated following the end of FY 2005 and FDA is to hold a public meeting to consult with its stakeholders and to determine whether the goals are appropriate for implementation in FY 2007.