Before a device can be marketed to the public, CDRH requires submissions of data to ensure safety and effectiveness. Depending on the classification of a device or on the need for a clinical trial, the submitted data is entered into one of several databases.
Premarket Summaries and Databases
Premarket Approval (PMA) Clinical Trials Database Premarket Approval (PMA) Summary Review Memos for 180-Day Design Changes Evaluation of Automatic Class III Designation (De Novo) Summaries Premarket Approvals (PMA) Database Search 510(k) Premarket Notification Database Search Listing of CDRH Humanitarian Device Exemptions Find All In Vitro Diagnostic Products and Decision Summaries Since November 2003
Premarket Programs and Processes
Overview of Medical Device Classification and Reclassification Reclassification FDA Summary of Safety and Effectiveness Data (SSED) Clinical Section Checklist Investigational Device Exemption (IDE) - Pivotal IDE Description Summary Form Guidance Documents (Medical Devices and Radiation-Emitting Products) 515 Program Initiative