FDA Training and Continuing Education

CDRH Learn Course List (English)

Listed below are the courses CDRH currently offers. Additional online courses are being developed and will be posted upon completion.

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
• Future Course Topics

http://www.fda.gov/Training/CDRHLearn/ucm162015.htm#guidance