New Japanese Agency Will Accept STED; MHLW Retains Payment Control
This article was originally published in The Gray Sheet
Executive Summary
Japan's Ministry of Health, Labor & Welfare will accept medical device applications in the STED format beginning next April, according to the U.S. Trade Representative's "1Third Report To The Leaders On The U.S.-Japan Regulatory Reform And Competition Policy Initiative," released June 8
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FDA/GHTF device premarket pilot extended
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)...