Zdrowie i gospodarka · 13.08.2010

Medical Device User Fee Act; Public Meeting; Request for Comments

The Food and Drug Administration (FDA) is announcing a public meeting on the reauthorization of the medical device user fee program. The current legislative authority for the medical device user fee program expires in September 2012 and new legislation will be required for FDA to continue collecting user fees for the medical device program. The Federal Food, Drug, and Cosmetic Act (FD&C Act) requires that before FDA begins negotiations with the regulated industry on medical device user fee program reauthorization, we publish a notice in the Federal Register requesting public input on the reauthorization, hold a public meeting at which the public may present its views on the reauthorization, provide a period of 30 days after the public meeting to obtain written comments from the public suggesting changes, and publish the comments on FDA's Web site. FDA invites public comment on the medical device user fee program and suggestions regarding the commitments FDA should propose for the next reauthorized program. Date and Time: The public meeting will be held on September 14, 2010, from 9 a.m. to 5 p.m. Location: FDA is currently in the process of determining the meeting location, which w