STED - Summary Technical Document Preparation
A Summary TEchnical Document (STED) is a standarized format for submitting information for regulatory approval of new devices. The STED format was created by the Global Harmonization Task Force (GHTF). The long term goal of STED is to standarize regulatory submissions for many countries. Currently, there are five participants actively using or evaluating STED as a pilot program: Australia, Canada, European Union, Japan and the United States. However, Health Canada has announced that it will no longer accept STED submissions at the end of 2008.
The information required for the preparation of a Summary Technical Document (STED) is similar to the documentation required for a US FDA 510(k) submission, Health Canada Medical Device License (MDL), European Technical File, and Japanese PMDA or RCB submissions.
Emergo Group has expertise in preparing STED documents, and we can fully assist in preparing or reviewing STED submissions for your medical devices.
