Zdrowie i gospodarka · 18.04.2007

Medical Device User Fee and Modernization Act; Public Meeting

The Food and Drug Administration (FDA) is announcing a public meeting to discuss our proposed recommendations for the reauthorization of the Medical Device User Fee and Modernization Act of 2002 (MDUFMA I) for fiscal years (FY) 2008 through 2012, as well as other proposals to improve the review of medical devices and the third party inspection program. These proposed recommendations were developed after discussions with the regulated industry. Section 105 of MDUFMA I directs FDA to publish these proposed recommendations in the Federal Register, hold a meeting at which the public may present its views on the recommendations, and provide for a period of 30 days for the public to provide written comments on the recommendations. The public meeting and comment period will provide an opportunity for public input on the proposed recommendations from all interested parties, including the regulated industry, scientific and academic experts, healthcare professionals, and representatives of patient and consumer advocacy groups.