Department of Health and Human Services August 13, 2010 – Federal Register Recent Federal Regulation Documents

The Food and Drug Administration (FDA) is announcing that a proposed collection of information has been submitted to the Office of Management and Budget (OMB) for review and clearance under the Paperwork Reduction Act of 1995.

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.