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U.S. Department of Health and Human Services

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FDA Summary of Safety and Effectiveness Data (SSED) Clinical Section Checklist

The Summary of Safety and Effectiveness (SSED) is a document mandated by the Food, Drug and Cosmetic Act subparagraph 520(h)(1)(A) to be publicly available upon issuance of an approval order of a premarket approval application (PMA).  The SSED is applicable for all original PMAs and panel-track supplements and is intended to inform regarding the FDA's decision making process   The SSED presents a reasoned, objective, and balanced summary of the scientific evidence, both positive and negative, that served as the basis of the decision to approve or deny the PMA.  SSEDs for all approved PMAs can be found in the PMA database.  The Clinical Section Checklist is used by CDRH clinical reviewers in preparing the clinical section of the SSED.  FDA is making this tool available to the public as part of the CDRH Transparency Initiative.