Monday, May 24, 2010

What is "STED"? Is STED Analogous to FDA's CTD?

STED is the Summary Technical Document format preferred by FDA for international medical device regulatory, clinical submissions. STED is a global pilot, voluntary program for PMA and 510(k) applications. Proposed STED guidelines were developed in the last decade by the Global Harmonization Task Force (GHTF) composed of 5 participating country members. GHTF encourages submitters of medical device applications to participate in this ongoing pilot program to ensure conformity across government regulatory agencies. Participating regulatory agencies who promote international harmonization via STED are the US, Australia, Canada, the European Union and Japan.

Proposed STED guidelines seek to ensure global documentation format conformity pertaining to safety and performance of medical device products. STED , in principle, is similar to the acknowledged and accepted CTD, Common Technical Document, which ensures documentation and format conformity across international country-specific drug regulatory, clinical submissions.

CDRH encourages medical device manufacturer participation in the STED Pilot Program. Data quality is expected to be high level, accurate, concise, quality controlled and quality assured. Pertaining to individual and simultaneous country-specific medical device filing(s), PMA or 510(k), outsource to expert regulatory, clinical consultants to ensure data accuracy, documentation and format consistency. To ensure ROI and filing success with no RTF, Refusal to File, seek QC experts. Contact

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