CDRH Transparency
For many years, FDA's Center for Devices and Radiological Health (CDRH) has provided information to help industry comply with FDA regulations.
In support of the FDA Transparency Initiative, CDRH is providing additional information to help the public understand its processes and decisions. The new information includes:
- information about regulatory decisions and the rationales for those decisions
- descriptions of regulatory processes
- data to support CDRH actions and public health activities
The additional pages on this Web site provide information about CDRH processes and decisions.
Topics
- Evaluation of Automatic Class III Designation (De Novo) Summaries
- Medical Device Accessory Classification Request Granting Decisions
- CLIA Waiver by Application Decision Summaries
- Premarket Approval (PMA) Summary Review Memos for 180-Day Design Changes
- Overview of Medical Device Classification and Reclassification
- Reclassification
- 515 Program Initiative
- CDRH Transparency: Total Product Life Cycle (TPLC)
- Radiation-Emitting Products Industry Assistance: Walk-through
- Questions and Answers about the Medical Device Innovation Initiative
CDRH Databases
- Premarket Approvals (PMA) Database Search
- 510(k) Premarket Notification Database Search
- MAUDE Database Search
- Medical Device Recalls Database
- Medical Device Databases
- Post-Approval Studies (PAS) Database
Performance Data and Transparency Resources
- openFDA: Devices - Recall Enforcement Reports
- FDA-TRACK Center for Devices & Radiological Health
- HHS Open Government
- Medical Device User Fee Amendments (MDUFA)
- MQSA National Statistics
- Device Approvals, Denials and Clearances
- CDRH Reports
Resources for You
- Medical Device Safety
- Device Advice: Comprehensive Regulatory Assistance
- Science and Research (Medical Devices)
- CDRH Events
- Medical Devices Advisory Committees
- Radiation-Emitting Products Advisory Committees
- CDRH Management Directory by Organization
- Contact Us -- Division of Industry and Consumer Education (DICE)