Advertisement
News
Advertisement

CDRHLearn: Intro to UDI and GUDID Overview

Mon, 12/23/2013 - 12:00am
U.S. Food & Drug Administration

Listed below are the courses CDRH currently offers. Additional online courses are being developed and will be posted upon completion.

Course List


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

[Back to Top]


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FDA Decisions for Investigational Device Exemption (IDE) Clinical Investigations [DRAFT Guidance]

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

FDA Guidance: Design Considerations for Pivotal Clinical Investigations for Medical Devices

[Back to Top]


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

[Back to Top]


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

[Back to Top]


CDRH Regulated Software: An Introduction

[Back to Top]


Quality System Regulation 21 CFR Part 820

[Back to Top]


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

[Back to Top]


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

[Back to Top]


Export Certificates for Medical Devices

[Back to Top]


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

[Back to Top]


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

[Back to Top]


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

[Back to Top]


Unique Device Identification (UDI) System

Unique Device Identification (UDI) System - The Final Regulation

Intro to UDI and GUDID Overview

[Back to Top]


Future Course Topics

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

[Back to Top]

 

Topics

Advertisement

Share this Story

X
You may login with either your assigned username or your e-mail address.
The password field is case sensitive.
Loading