Training & Continuing Education Courses
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
- Quality System Regulation 21 CFR Part 820 Basic Introduction
- Device Establishment Registration and Listing
- Overview of the Premarket Notification Process – 510(k)
- How to Get Your Electronic Product on the U.S. Market
- Bioresearch Monitoring (BIMO)
- Future Course Topics
Overview of Regulatory Requirements: Medical Devices
Quality System Regulation 21 CFR Part 820 Basic Introduction
Device Establishment Registration and Listing
Overview of the Premarket Notification Process – 510(k)
510(k) Overview
Product Codes Making the Connection...
510(k) Format Guidance, Including Standards Form, and Extensions/Clinical Trial Form and 510(k)
510(k) User Fees
510(k) Third Party Review
"513(g)s".. Including 513(g) User Fees
Post Test for all 510(k) Modules
How to Get Your Electronic Product on the U.S. Market
Bioresearch Monitoring (BIMO)
BIMO Part 1a - Good Clinical Practice 101: An Introduction
BIMO Part 1b - Introduction to the Bioresearch Monitoring Program
BIMO Part 2a - The Sponsor: Responsibilities in Medical Device Clinical Trials
BIMO Part 2b - The Clinical Investigator: Responsibilities in Medical Device Trials
BIMO Part 2c - Computerized Systems Used in Medical Device Clinical Investigations
BIMO Part 3a - Institutional Review Board: Responsibilities in Making the Significant Risk and Non-significant Risk Device Determination
BIMO Part 3b - Institutional Review Board: Humanitarian Use Devices (HUDs)
BIMO Part 3c - Institutional Review Board: Compassionate and Emergency Use
BIMO Part 4a - Preparing for an FDA Medical Device Sponsor Inspection
BIMO Part 4b - Preparing for an FDA Clinical Investigator Inspection
BIMO Part 4c - Preparing for an FDA Institutional Review Board Inspection
BIMO Part 5a - Strategies for Sponsors to Build Quality into Device Research
BIMO Part 5b - Strategies For Clinical Investigators to Build Quality into Device Research
Future Course Topics
- CDRH Regulated Software
- Recalls
- Medical Device Reporting (MDR)
- Advanced Quality Systems
- Imports