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Summary Technical Document (STED) Pilot Program

BayBiotech.NET
STED is a harmonized submission format for regulatory submissions developed by the Global Harmonization Task Force (GHTF).

GHTF is a voluntary partnership of government and industry representatives from the United States and four other member states: Australia, Canada, the European Union, and Japan. Main objective of the GHTF is to promote international harmonization of medical device regulation through the preparation and distribution of guidelines such as the proposed STED format.

CDRH has implemented a voluntary pilot premarket review program intended to assess the feasibility of the STED format and content for certain PMA applications and 510(k) submissions and encourages medical device manufacturers to participate in the STED Pilot Program. The participation in the program will benefit the manufacturers especially those seeking international regulatory approval/clearance for their devices.

To find out more about the program as well as the eligibility of your device click on STED.

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