Training and Continuing Education
Welcome to CDRH Learn, FDA’s Center for Devices and Radiological Health (CDRH) Web page for industry education. CDRH is responsible for ensuring the safety and effectiveness of medical devices and eliminating unnecessary human exposure to man-made radiation from medical, occupational and consumer products. We are committed to educating industry on the relevant policies and regulations.
CDRH Learn is our latest innovative educational tool. It consists of a series of training modules describing many aspects of medical device and radiological health regulation, covering both premarket and postmarket issues. This tool is intended to provide the medical device and radiological health industry with an information resource that is comprehensive, interactive, and easily accessible.
Listed below are the course topics CDRH currently offers. Additional online courses are being developed and will be posted upon completion.
- Overview of Regulatory Requirements: Medical Devices
- Guidance Documents and Standard Operating Procedures (SOPs) [Updated! 3/24/2014]
- Premarket Notification Process - 510(k)
- Investigational Device Exemption Process - IDE
- Bioresearch Monitoring (BIMO)
- Device Establishment Registration and Listing
- CDRH Regulated Software: An Introduction
- Quality System Regulation 21 CFR Part 820
- Medical Device Recalls
- Medical Device Reporting (MDR)
- Export Certificates for Medical Devices
- Regulation of Radiation-Emitting Products
- Global Initiatives
- Medical Devices in the Home
- Unique Device Identification (UDI) System [Updated! 1/31/2014]
- Clinical Laboratory Improvement Amendments (CLIA) [Updated! 3/18/14]
- Future Course Topics
The presenters are FDA / CDRH staff and therefore, as employees, have claimed no interests, financial or otherwise, with medical device or radiation-emitting products that may be shown in any of the presentations.