News
Listed below are the courses CDRH currently offers. Additional online courses are being developed and will be posted upon completion.
- Overview of Regulatory Requirements: Medical Devices [Updated! 11/29/2011]
- Guidance Documents and Standard Operating Procedures (SOPs) [New! 12/27/2011]
- 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
Overview of Regulatory Requirements: Medical Devices
Guidance Documents and Standard Operating Procedures (SOPs)
The 510(k) Program: Evaluating Substantial Equivalence in Premarket Norifications or 510(k)s
Premarket Notification Process – 510(k)
The 510(k) Program: Evaluating Substantial Equivalence in Premarket Norifications 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 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
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)
FDA's Home Use Medical Device Initiative
Promoting Patient Safety with Home Use Devices
Home Use Medical Devices: New Risks
- Advanced Quality Systems: Corrective and Preventive Actions
- Imports
- Premarket Approvals
- Home Healthcare
Topics
