CDRHLearn: Intro to UDI and GUDID Overview

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
  • Guidance Documents and Standard Operating Procedures (SOPs) 
  • Premarket Notification Process – 510(k)
  • Investigational Device Exemption Process – IDE [Updated! 12/4/2013]
  • Bioresearch Monitoring (BIMO)
  • Device Establishment Registration and Listing [Updated! 12/6/2013]
  • CDRH Regulated Software: An Introduction
  • Quality System Regulation 21 CFR Part 820
  • Medical Device Recalls
  • Medical Device Reporting (MDR)
  • Export Certificates for Medical Devices
  • Regulation of Radiation-Emitting Products
  • Global Initiatives [Updated! 10/31/2013]
  • Medical Devices in the Home
  • Unique Device Identification (UDI) System [Updated! 12/23/2013]
  • Future Course Topics

Overview of Medical Device Regulations

Overview of Regulatory Requirements: Medical Devices

Medical Device User Fee Amendments 2012 – MDUFA III Overview

Guidance Documents and Standard Operating Procedures (SOPs)

Unique Device Identification (UDI) System

Factors to Consider When Making Benefit-Risk Determinations in Medical Device Premarket Approval and De Novo Classifications

The 510(k) Program: Evaluating Substantial Equivalence in Premarket Notifications or 510(k)s

Premarket Notification Process – 510(k)

The 510(k) Program: Evaluating Substantial Equivalence in Premarket Notifications 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 disclaimer icon

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Investigational Device Exemption Process – IDE

What is an Investigational Device Exemption (IDE)?

Idea to IDE: A Medical Device in the Making

FDA Decisions for Investigational Device Exemption (IDE) Clinical Investigations [DRAFT Guidance]

  • Printable Slide Presentation
  • Audio Recording
  • Transcript

Printable Slide Presentation

  • Audio Recording
  • Transcript

    • Printable Slide Presentation

  • Audio Recording
  • Transcript

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    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

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

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    Device Establishment Registration and Listing

    Overview of Device Establishment Registration and Listing

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

    FURLS Device Registration and Listing Module Annual Registration

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    CDRH Regulated Software: An Introduction

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    Quality System Regulation 21 CFR Part 820

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    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 Recalls: Guidance for Industry

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    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

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    Export Certificates for Medical Devices

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    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

    • eSubmitter Tutorial Videos
    • Radiological Health Report Tutorial

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    Global Initiatives

    International Medical Device Regulators Forum (IMDRF) Medical Device Single Audit Program (MDSAP) Pilot

    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) disclaimer icon

    TEST LINK: GD211 Training Course (French Canadian) disclaimer icon

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    Medical Devices in the Home

    FDA’s Home Use Medical Device Initiative

    Promoting Patient Safety with Home Use Devices

    Home Use Medical Devices: New Risks

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    Unique Device Identification (UDI) System

    Unique Device Identification (UDI) System – The Final Regulation

    GUDID Overview (with UDI Introduction)

    • Printable Slide Presentation
    • Audio Recording (MP3)
    • Transcript

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    Future Course Topics

    • Advanced Quality Systems: Corrective and Preventive Actions
    • Imports
    • Premarket Approvals

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