CDRH Learn (New Course Available

By Effective Medicine  On  In Medical Devices Tagged  

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
  • Medical Device Recalls [New! 6/1/2011]
  • CDRH Regulated Software: An 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
  • Phantom Image Scoring (For MQSA Inspectors)
  • eSubmitter Tutorial Videos
  • Bioresearch Monitoring (BIMO)
  • Export Certificates for Medical Devices
  • Medical Device Reporting (MDR)
  • Future Course Topics

Overview of Regulatory Requirements: Medical Devices

Quality System Regulation 21 CFR Part 820 Basic Introduction

Medical Device Recalls

Introduction to Medical Device Recalls: Industry Responsibilities

Recall Module 21 CFR Part 806: Medical Devices; Reports of Corrections and Removals

CDRH Regulated Software: An 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

Phantom Image Scoring (For MQSA Inspectors)

eSubmitter Tutorial Videos
  • Radiological Health Report Tutorial

    • 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

    Export Certificates for Medical Devices

    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

    Future Course Topics

    • Advanced Quality Systems
    • Imports
    • Investigational Device Exemptions
    • Premarket Approvals
    • Corrective Actions
    • Home Healthcare

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