To comply with FDAAA 801, must I submit information to ClinicalTrials.gov, or can I use another registry or results database?

You must use ClinicalTrials.gov to fulfill the requirements of FDAAA 801 (PDF). FDAAA 801 requires Responsible Parties to submit clinical trial information to the Director of the National Institutes of Health (NIH) for inclusion in the registry and results database established via ClinicalTrials.gov.