October 1, 2011 through September 30, 2012 -- This letter is to notify you of the fiscal year 2012, (October 1, 2011-September 30, 2012), fee rates and payment procedures for medical device user fees payable to the United States Food and Drug Administration, (US FDA). This information was also announced in the Federal Register notice published on August 1, 2011 and is available at: http://www.gpo.gov/fdsys/pkg/FR-2011-08-01/html/2011-19335.htm2. The Federal Food, Drug, and Cosmetic Act, (FD&C Act), as amended by the Medical Device User Fee Amendments of 2007, (“the 2007 Amendments”), authorizes the FDA to collect user fees for certain medical device applications. Fees apply to Premarket Approvals, (PMAs); Product Development Protocols, (PDPs); Premarket Reports, (PMRs); Biologics Licensing Applications, (BLAs for certain medical devices reviewed by FDA's Center for Biologics Evaluation and Research [CBER]); some PMA, PDP and BLA supplements; and Premarket Notifications, [510(k)s]. Additionally, the 2007 Amendments authorize the FDA to collect fees for 30-day notices; requests for information regarding classification [513(g)s]; and annual fees for periodic reporting on class III medical devices and for the registration of certain medical device establishments. The information regarding who must register, list and pay the fee is available at: Device Advice - Who Must Register, List and Pay the Fee3.
