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.
Decision Summaries, Databases, and Premarket Reports
- 510(k) Third Party Performance Metrics and Accreditation Status
- 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
- CLIA Waiver by Application Decision Summaries
- Medical Device Accessory Classification Request Granting Decisions
Premarket Programs and Processes
- Overview of Medical Device Classification and Reclassification
- Reclassification
- Guidance Documents (Medical Devices and Radiation-Emitting Products)
- 515 Program Initiative
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