CDRH Transparency: Premarket Submissions
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) 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