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FDA/GHTF device premarket pilot extended

This article was originally published in The Gray Sheet

Executive Summary

July 6 guidance document says the voluntary program incorporating "Summary Technical Documentation for Demonstrating Conformity" (STED) format for PMA and 510(k) submissions "will remain active until at least June 2005." Under the FDA guidance, which supersedes a June 2003 version, the same four CDRH divisions will participate and additional devices for the pilot still may be requested on a case-by-case basis. In June, Japan committed to accepting device applications in the STED format, originally developed by a Global Harmonization Task Force study group (1"The Gray Sheet" June 21, 2004, p. 27)...
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