CDRH Learn Course Updates

FDA’s Center for Devices and Radiological Health (CDRH) offers online courses to help medical device manufacturers. The list below includes the complete list of courses in English, including some recently updated. The URL for the courses is

Course List

  • Overview of Regulatory Requirements: Medical Devices [Updated 11/29/2011]
  • Guidance Documents and Standard Operating Procedures (SOPs) [Updated 04/10/2012]
  • Premarket Notification Process – 510(k)
  • Investigational Device Exemption Process – IDE [Updated 2/23/2012]
  • Bioresearch Monitoring (BIMO) [Updated 2/23/2012]
  • Device Establishment Registration and Listing
  • CDRH Regulated Software: An Introduction
  • Quality System Regulation 21 CFR Part 820
  • Medical Device Recalls [Updated 2/23/2012]
  • Medical Device Reporting (MDR)
  • Export Certificates for Medical Devices
  • Regulation of Radiation-Emitting Products
  • Global Initiatives [Updated 03/23/2012]
  • Medical Devices in the Home