Training and Continuing Education

CDRH Learn

Welcome to CDRH Learn, FDA’s Center for Devices and Radiological Health (CDRH) web page for multimedia industry education. CDRH Learn is our innovative educational tool, which consists of learning modules describing many aspects of medical device and radiation emitting product regulations, covering both premarket and postmarket topics. This tool is intended to provide industry with information that is comprehensive, interactive, and easily accessible. Modules are provided in various formats, including videos, audio recordings, and slide presentations. CDRH will determine the most appropriate format for the particular topic being presented, and will post the learning module on this site to meet your educational needs!

Disclosure: The presenters are FDA / CDRH staff and therefore, as employees, have claimed no interests, financial or otherwise, with medical device or radiation-emitting products that may be shown in any of the presentations.

Overview of Regulatory Requirements: Medical Devices
Video Closed Captioned   Printable Slides   Transcript   Post Test

Medical Device User Fee Amendments 2012 - MDUFA III Overview
Video Closed Captioned   Printable Slides   Transcript


Registration and Listing

Overview of Device Establishment Registration and Listing
Video Closed Captioned   Printable Slides   Post Test

Paying the Annual Registration User Fee via the Device Facility User Fee (DFUF) Website
Interactive Presentation   Printable Slides

FURLS Device Registration and Listing Module Annual Registration
Interactive Presentation   Printable Slides

Premarket Notification (510k)

Premarket Notification 510(k) Overview
Video Closed Captioned   Printable Slides

510(k) Format Guidance, Including Standards Form, and Extensions/Clinical Trial Form and 510(k)
Video Closed Captioned   Printable Slides

The 510(k) Program: Evaluating Substantial Equivalence in Premarket Notifications or 510(k)s
Video Closed Captioned   Printable Slides    Transcript

510(k) Third Party Review
Video Closed Captioned   Printable Slides

510(k) Electronic Submission Pilot Program - New! 5/5/14
Printable Slides   Transcript

Post Test for all 510(k) Modules


Clinical Studies/Investigational Device Exemption (IDE)

What is an Investigational Device Exemption (IDE)?
Video Closed Captioned   Printable Slides   Transcript

Idea to IDE: A Medical Device in the Making
Video Closed Captioned

FDA Decisions for Investigational Device Exemption (IDE) Clinical Investigations [DRAFT Guidance]
Audio Recording (MP3)   Printable Slides   Transcript

IDEs for Early Feasibility Medical Device Clinical Studies, Including First in Human (FIH) Studies
Audio Recording (MP3)   Printable Slides   Transcript

FDA Guidance: Design Considerations for Pivotal Clinical Investigations for Medical Devices
Audio Recording (MP3)   Printable Slides   Transcript


Biorearch Monitoring (BIMO)

BIMO Part 1a - Good Clinical Practice 101: An Introduction
Video Closed Captioned   Printable Slides   Post Test

BIMO Part 1b - Introduction to the Bioresearch Monitoring Program
Video Closed Captioned   Printable Slides   Post Test

BIMO Part 2a - The Sponsor: Responsibilities in Medical Device Clinical Trials
Video Closed Captioned   Printable Slides   Post Test

BIMO Part 2b - The Clinical Investigator: Responsibilities in Medical Device Trials
Video Closed Captioned   Printable Slides   Post Test

BIMO Part 2c - Computerized Systems Used in Medical Device Clinical Investigations
Video Closed Captioned   Printable Slides   Post Test

BIMO Part 3a - Institutional Review Board: Responsibilities in Making the Significant Risk and Non-significant Risk Device Determination
Video Closed Captioned   Printable Slides   Post Test

BIMO Part 3b - Institutional Review Board: Humanitarian Use Devices (HUDs)
Video Closed Captioned   Printable Slides   Post Test

BIMO Part 3c - Institutional Review Board: Compassionate and Emergency Use
Video Closed Captioned   Printable Slides   Post Test

BIMO Part 4a - Preparing for an FDA Medical Device Sponsor Inspection
Video Closed Captioned   Printable Slides   Post Test

BIMO Part 4b - Preparing for an FDA Clinical Investigator Inspection
Video Closed Captioned   Printable Slides   Post Test

BIMO Part 4c - Preparing for an FDA Institutional Review Board Inspection
Video Closed Captioned   Printable Slides   Post Test

BIMO Part 5a - Strategies for Sponsors to Build Quality into Device Research
Video Closed Captioned   Printable Slides   Post Test

BIMO Part 5b - Strategies For Clinical Investigators to Build Quality into Device Research
Video Closed Captioned   Printable Slides   Post Test

Preparing for a Clinical Investigator Inspection
Video Closed Captioned   Transcript

CDER Small Business Webinar on Building Quality into Clinical Trials – an FDA Perspective


Classification

"513(g)s" Including 513(g) User Fees
Video Closed Captioned   Printable Slides

Product Codes Making the Connection
Video Closed Captioned   Printable Slides

Medical Device Classification and Reclassification Procedures – Proposed Rule
Recorded Webinar (3/24/14) Closed Captioned   Printable Slides   Transcript


Cross-Cutting Premarket Policy

How to Create and Submit an eCopy
Video Closed Captioned

510(k) User Fees
Video Closed Captioned   Printable Slides

Factors to Consider When Making Benefit-Risk Determinations in Medical Device Premarket Approval and De Novo Classifications
Video Closed Captioned   Printable Slides   Transcript

Pre-Submissions and Meetings with FDA Staff
Recorded Webinar (2/28/14) Closed Captioned   Printable Slides   Transcript

Start Here! Quality System Regulation Overview
Video Closed Captioned   Printable Slides   Post Test


Medical Device Recalls

Introduction to Medical Device Recalls: Industry Responsibilities
Video Closed Captioned   Printable Slides

Recall Module 21 CFR Part 806: Medical Devices; Reports of Corrections and Removals
Video Closed Captioned   Printable Slides

Recall Communication: Medical Device Model Press Release
Video Closed Captioned   Printable Slides   Transcript   Post Test

Recall Communication: Medical Device Model Recall Notification Letter
Video Closed Captioned   Printable Slides   Transcript   Post Test

Medical Device Recalls: Guidance for Industry
Video Closed Captioned   Post Test


Medical Device Reporting (MDR)

MAUDE - Information Available to the Public
Video Closed Captioned   Printable Slides   Post Test

Electronic Medical Device Reporting (eMDR)
Video Closed Captioned   Printable Slides   Post Test

Medical Device Reporting
Video Closed Captioned   Printable Slides   Post Test

MDR for User Facilities
Video Closed Captioned   Printable Slides   Post Test

MDR for Manufacturers and Importers
Video Closed Captioned   Printable Slides   Post Test


Exporting Devices

Export Certificates for Medical Devices
Video Closed Captioned   Printable Slides   Post Test


Inspections - Global Harmonization

ISO 13485:2003 Voluntary Audit Report Submission Pilot Program
Video Closed Captioned   Printable Slides   Transcript

International Medical Device Regulators Forum (IMDRF) Medical Device Single Audit Program (MDSAP) Pilot
Video Closed Captioned   Printable Slides   Transcript

GD211: Welcome and Introduction by Dr. Jeff Shuren and Dr. Surpriya Sharma
Video Closed Captioned   Video (French audio only) Closed Captioned

GD211: Module 1 - Introduction
Video Closed Captioned   Video (French audio only) Closed Captioned

GD211: Module 2 - Information about the Manufacturer
Video Closed Captioned   Video (French audio only) Closed Captioned

GD211: Module 3 - Information about the Audit
Video Closed Captioned   Video (French audio only) Closed Captioned

GD211: Module 4 - Audit Findings
Video Closed Captioned   Video (French audio only) Closed Captioned

GD211: Module 5 - Conclusions
Video Closed Captioned   Video (French audio only) Closed Captioned

Post Test
GD211 Training Course (English)   GD211 Training Course (French)

Unique Device Identification (UDI) System
Video Closed Captioned   Printable Slides   Transcript

Unique Device Identification (UDI) System - The Final Regulation
Video Closed Captioned   Printable Slides   Transcript

GUDID Overview (with UDI Introduction)
Audio Recording (MP3)   Printable Slides   Transcript

GUDID - Account Set-up
Audio Recording (MP3)   Printable Slides   Transcript

Software

CDRH Regulated Software: An Introduction
Video Closed Captioned   Printable Slides


Home Use

FDA's Home Use Medical Device Initiative
Video Closed Captioned   Printable Slides   Post Test

Promoting Patient Safety with Home Use Devices
Video Closed Captioned   Printable Slides

Home Use Medical Devices: New Risks
Video Closed Captioned   Printable Slides

How to Get Your Electronic Product on the U.S. Market
Video Closed Captioned   Printable Slides   Post Test

Phantom Image Scoring (For MQSA Inspectors)
Video Closed Captioned   Post Test

eSubmitter Tutorial Videos
eSubmitter Tutorial Videos   Radiological Health Report Tutorial

Clinical Laboratory Improvement Amendments (CLIA)
Audio Recording (MP3)   Printable Slides   Transcript


Contact FDA

1-800-638-2041
301-847-8142 Fax
cdrhlearn@fda.hhs.gov

CDRH Learn
CDRH-Center for Devices and Radiological Health
Food and Drug Administration
10903 New Hampshire Avenue
WO66-4303
Silver Spring, MD 20993

 

Page Last Updated: 07/21/2014
Note: If you need help accessing information in different file formats, see Instructions for Downloading Viewers and Players.