FDA Extends STED Pilot Program Until July 2006

The FDA's Center for Devices and Radiological Health has extended its pilot program for evaluating globally harmonized medical device premarket applications, accepting submissions in this format until July 2006.

Under this program, the FDA is permitting manufacturers to submit certain premarket notifications, or 510(k)s, and premarket approval applications in a summary technical document (STED) format. The STED format for regulatory submissions is a harmonized submission format developed by the Global Harmonization Task Force, a voluntary partnership of government and industry representatives from the U.S. and four other member states.

The FDA is encouraging medical device manufacturers to participate in the STED pilot program. Manufacturers will benefit from exposure to the STED preparation process, especially those seeking international regulatory approval or clearance for their devices.

More information can be found online at http://www.ghtf.org/sg1/sg1-proposed.html (http://www.ghtf.org/sg1/sg1-proposed.html) and http://www.fda.gov/cdrh/ode/guidance/1347.html (http://www.fda.gov/cdrh/ode/guidance/1347.html).