FDA has new Web site for medical devices

Dec. 5, 2002
The new law effects user fees for premarket reviews, establishes provisions for accredited third-party inspections and provides a new regulatory requirement for reprocessed single use devices.

The FDA's Center for Devices and Radiological Health has created a web site dedicated to description and explanation of the changes to the Federal Food, Drug and Cosmetic Act contained in the Medical Device User Fee and Modernization Act of 2002 which was signed by President Bush on October 26.

The new law effects user fees for premarket reviews, establishes provisions for accredited third-party inspections and provides a new regulatory requirement for reprocessed single use devices. The link to the Web site is http://www.fda.gov/cdrh/mdufma/index.html.