One challenge that many regulatory professionals face is finding applicable and relevant data to conduct their day-to-day activities. Regulatory intelligence is important in the constantly evolving healthcare industry for activities such as submissions, pre- and post-market risk assessment, design controls, continuous improvement, and compliance.
In an effort to aid in the collection of information, I'm going to post links to key websites each week to regulatory intelligence resources. This week we will focus on Government Databases.
- US FDA Title 21 Code of Federal Regulations
- Warning Letter Database
- CDRH Guidance Documents
- CDRH MAUDE Database
- CDRH Medical Device Reporting Database
- Clinical Trials Database
- Medical Device Product Classification
- 510(k) Database
- Establishment Registration and Product Listing Database
- CDRH Recognized Consensus Standards
-RTK