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CDRH Learn (New Course Available - Recall Module 21 CFR Part 806: Medical Devices; Reports of Corrections and Removals)

Posted Jun 01 2011 12:00am

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

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

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

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