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! 7/12/2012]
- 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! 5/23/2012]
- Medical Device Reporting (MDR)
- Export Certificates for Medical Devices
- Regulation of Radiation-Emitting Products
- Global Initiatives [Updated! 3/23/2012]
- Medical Devices in the Home
- Unique Device Identification (UDI) System [New! 7/12/2012]
- Future Course Topics
Overview of Regulatory Requirements: Medical Devices
Guidance Documents and Standard Operating Procedures (SOPs)
Unique Device Identification (UDI) System
Factors to Consider When Making Benefit-Risk Determinations in Medical Device Premarket Approval and De Novo Classifications
The 510(k) Program: Evaluating Substantial Equivalence in Premarket Notifications or 510(k)s
Premarket Notification Process – 510(k)
The 510(k) Program: Evaluating Substantial Equivalence in Premarket Notifications or 510(k)s
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 
Investigational Device Exemption Process - IDE
What is an Investigational Device Exemption (IDE)?
Idea to IDE: A Medical Device in the Making
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
Preparing for a Clinical Investigator Inspection
Device Establishment Registration and Listing
CDRH Regulated Software: An Introduction
Quality System Regulation 21 CFR Part 820
Medical Device Recalls
Introduction to Medical Device Recalls: Industry Responsibilities
Recall Module 21 CFR Part 806: Medical Devices; Reports of Corrections and Removals
Recall Communication: Medical Device Model Press Release
Recall Communication: Medical Device Model Recall Notification Letter
Medical Device Recalls: Guidance for Industry
Medical Device Reporting (MDR)
MAUDE - Information Available to the Public
Electronic Medical Device Reporting (eMDR)
Medical Device Reporting
MDR for User Facilities
MDR for Manufacturers and Importers
Export Certificates for Medical Devices
Regulation of Radiation-Emitting Products
How to Get Your Electronic Product on the U.S. Market
Phantom Image Scoring (For MQSA Inspectors)
eSubmitter Tutorial Videos
Global Initiatives
ISO 13485:2003 Voluntary Audit Report Submission Pilot Program
Single Audit Program - Quality Management System Audit Reports (GD211)
GD211 - Welcome and Introduction by Dr. Jeff Shuren and Dr. Surpriya Sharma
GD211 - Welcome and Introduction by Dr. Jeff Shuren and Dr. Surpriya Sharma (French audio-only)
GD211 - Module 1 - Introduction
GD211 - Module 1 - Introduction (French audio-only)
GD211 - Module 2 - Information about the Manufacturer
GD211 - Module 2 - Information about the Manufacturer (French audio-only)
GD211 - Module 3 - Information about the Audit
GD211 - Module 3 - Information about the Audit (French audio-only)
GD211 - Module 4 - Audit Findings
GD211 - Module 4 - Audit Findings (French audio-only)
GD211 - Module 5 - Conclusions
GD211 - Module 5 - Conclusions (French audio-only)
TEST LINK: GD211 Training Course (English)
TEST LINK: GD211 Training Course (French Canadian)
Medical Devices in the Home
FDA's Home Use Medical Device Initiative
Promoting Patient Safety with Home Use Devices
Home Use Medical Devices: New Risks
Unique Device Identification (UDI) System
Future Course Topics
- Advanced Quality Systems: Corrective and Preventive Actions
- Imports
- Premarket Approvals
