Zdrowie i gospodarka · 23.07.2004

Medical Devices: A Pilot Program to Evaluate a Proposed Globally Harmonized Alternative for Premarket Procedures; Final Guidance for Industry and FDA Staff; Availability

The Food and Drug Administration (FDA) is announcing the availability of a revised final guidance entitled "A Pilot Program to Evaluate a Proposed Globally Harmonized Alternative for Premarket Procedures; Guidance for Industry and FDA Staff." This revised guidance extends by 1 year a voluntary pilot premarket review program that may reduce the burden on manufacturers who face conflicting premarket submission format and content requirements in different countries. The pilot program is intended to evaluate the utility of an alternative submission procedure as described in the document entitled "Summary Technical Documentation for Demonstrating Conformity to the Essential Principles of Safety and Performance of Medical Devices" (draft STED document). The draft STED document was developed by Study Group 1 (SG1) of the Global Harmonization Task Force (GHTF) and issued as a working draft in December 2000. The GHTF is a voluntary group comprised of medical device regulatory officials and industry representatives from the United States, Canada, Australia, the European Union, and Japan. Each of these member countries will participate in the pilot program and will provide specific directions