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
Presentation Closed Captioned   Printable Slides   Transcript   Post Test

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


Registration and Listing

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

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

FURLS Device Registration and Listing Module Annual Registration
Presentation   Printable Slides

FURLS Device Registration and Listing Module for Initial Registration New! 11/19/14
Presentation

Premarket Notification (510k)

The 510(k) Program New! 11/4/14
Presentation Closed Captioned   Printable Slides    Transcript

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

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

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

510(k) Electronic Submission Pilot Program
Printable Slides   Transcript

Post Test for all 510(k) Modules


De Novo

De Novo Program New! 11/4/14
Presentation Closed Captioned   Printable Slides   Transcript


Clinical Studies/Investigational Device Exemption (IDE)

IDE Basics New! 11/4/14
Presentation Closed Captioned   Printable Slides   Transcript

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

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

FDA Guidance: Design Considerations for Pivotal Clinical Investigations for Medical Devices
Presentation   Printable Slides   Transcript

Evaluation of Sex-Specific Data in Medical Device Clinical Studies
Presentation (8/26/14)   Printable Slides   Transcript

FDA Decisions for Investigational Device Exemption (IDE) Clinical Investigations
Presentation (9/4/14)   Printable Slides   Transcript

Biorearch Monitoring (BIMO)

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

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

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

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

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

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

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

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

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

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

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

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

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

Preparing for a Clinical Investigator Inspection
Presentation Closed Captioned   Transcript


Cross-Cutting Premarket Policy

How to Create and Submit an eCopy
Presentation Closed Captioned

510(k) User Fees
Presentation Closed Captioned   Printable Slides

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

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


Classification

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

Product Codes Making the Connection
Presentation Closed Captioned   Printable Slides

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

Quality System

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

Corrective and Preventive Actions New! 11/4/14
Presentation Closed Captioned   Printable Slides   Transcript


Exporting Devices

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


Medical Device Recalls

Distinguishing Medical Device Recalls from Medical Device Enhancements New! 11/14/14
Presentation (11/5/14)   Printable Slides   Transcript

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

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

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

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

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


Medical Device Reporting (MDR)

Electronic Medical Device Reporting (eMDR) New! 11/4/14
Presentation Closed Captioned   Printable Slides   Transcript

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

Medical Device Reporting
Presentation Closed Captioned   Printable Slides   Post Test

MDR for User Facilities
Presentation Closed Captioned   Printable Slides   Post Test

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

Inspections - Global Harmonization

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

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

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

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

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

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

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

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

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

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

GUDID Overview (with UDI Introduction)
Presentation   Printable Slides   Transcript

GUDID - Account Set-up
Presentation   Printable Slides   Transcript

GUDID - Device Identifier Record
Presentation (7/23/14)   Transcript

GUDID - HL7 SPL Submission Option Overview
Presentation   Transcript

Custom Devices

Custom Device Exemption - Updated! 10/27/14
Presentation (10/14/14)   Transcript   Printable Slides

IT and Software

Content of Premarket Submissions for Management of Cybersecurity in Medical Devices - New! 11/7/14
Presentation (10/29/14)   Printable Slides   Transcript

CDRH Regulated Software: An Introduction
Presentation Closed Captioned   Printable Slides

Home Use

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

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

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

Medical Devices in the Home: Design Considerations and Guidance for Industry
Presentation (9/9/14)   Printable Slides   Transcript

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

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

eSubmitter Tutorial Presentations
eSubmitter Tutorial Presentations   Radiological Health Report Tutorial

Clinical Laboratory Improvement Amendments (CLIA)
Presentation   Printable Slides   Transcript

Framework for Regulatory Oversight of Laboratory Developed Tests (LDTs) - New! 10/30/14
Presentation (10/23/14)   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: 12/17/2014
Note: If you need help accessing information in different file formats, see Instructions for Downloading Viewers and Players.