Training and Continuing Education
CDRH Learn Course List (Chinese)
Listed below are the courses CDRH currently offers in Mandarin Chinese. 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
- Overview of the Premarket Notification Process - 510(k)
- Bioresearch Monitoring (BIMO) [New! Parts Added 5/18]
- Medical Device Reporting [New! 5/18]
Overview of Regulatory Requirements: Medical Devices
Quality System Regulation 21 CFR Part 820 Basic Introduction
Overview of the Premarket Notification Process - 510(k)
Part 1: 510(k) Overview
Heather Rosecrans - Director, 510(k) Staff - Office of Device Evaluation, CDRH, FDA
Part 2: 510(k) Product Codes
Julie "Brandi" Stuart - Center Product Code Coordinator - Consumer Safety Officer - Office of Device Evaluation, CDRH, FDA
Part 3: 510(k) Format Guidance, Including Standards Form, Extensions/Clinical Trial Form and 510(k)
Marjorie Shulman - Consumer Safety Officer - Premarket Notification (510(k)) Staff - Office of Device Evaluation, CDRH, FDA
Part 4: 510(k) User Fees
(510(k)) Staff - Office of Device Evaluation, CDRH, FDA
Part 5: 510(k) 3rd Party Review
Eric Rechen - Policy Analyst - Program Operations Staff - Office of Device Evaluation, CDRH, FDA
Part 6: 513(g)s, including 513(g) user fees
Lawrence "Jake" Romanell - Regulatory Affairs and Special Interests Network - Office of the Center Director – CDRH, FDA
Bioresearch Monitoring (BIMO)
BIMO Part 1a - Good Clinical Practice 101: An
Introduction
"Lester “Jao” Lacorte, MD, Medical Officer
This module defines Good Clinical Practice, outlines the goals, provides historical perspective and highlights FDA regulations relating to device research.
BIMO Part 1b - Introduction to the Bioresearch Monitoring Program
Janet Cooper, MT, MFS, Consumer Safety Officer
BIMO Part 2a - The Sponsor: Responsibilities in Medical Device Clinical Trials
Catherine Parker, RN - Consumer Safety Officer - CDRH
BIMO Part 2b - The Clinical Investigator: Responsibilities in Medical Device Trials
Catherine Parker, RN - Consumer Safety Officer - CDRH
BIMO Part 2c - Computerized Systems Used in Medical Device Clinical Investigations
Jonathan Helfgott, MS, Consumer Safety Officer
BIMO Part 3a - Institutional Review Board: Responsibilities in Making the Significant Risk and Non-significant Risk Device Determination
Janette Collins-Mitchell, MS, RN, Nurse Consultant
BIMO Part 3b - Institutional Review Board: Humanitarian Use Devices (HUDs)
Fabienne Santel, MD, Medical Officer
This module defines HUDs and the device regulations that govern these types of devices.
BIMO Part 3c - Institutional Review Board: Compassionate and Emergency Use
Fabienne Santel, MD, Medical Officer
This module explains compassionate and emergency use for device research and expands upon the requirements for reporting.
BIMO Part 4a - Preparing for an FDA Sponsor Inspection
Allen Lou, Consumer Safety Officer
This module explains unique techniques on how to prepare for an FDA sponsor inspection and outlines what records will be inspected. It also explains the FDA regulations requirements for sponsors.
BIMO Part 4b - Preparing for an FDA Clinical Investigator Inspections
Allen Lou, Consumer Safety Officer
This module explains distinctive attributes on how to prepare for an FDA clinical investigator inspection and outlines what records will be inspected. It also explains the FDA regulations requirements for clinical investigators.
BIMO Part 4c - Preparing for an FDA Institutional Review Board Inspection
Allen Lou, Consumer Safety Officer
This module explains how to prepare for an FDA institutional review board (IRB) inspection and outlines what records will be inspected. It also explains the FDA regulations requirements for IRBs.
BIMO Part 5a - Strategies for Sponsors to Build Quality into Device Research
Donna Headlee, RN, BSN, CCRP, Consumer Safety Officer
This module identifies the elements of quality throughout the data life cycle of a clinical trial and identifies best practices that a clinical investigator can implement to ensure a quality study.
BIMO Part 5b - Strategies For Clinical Investigators to Build Quality into Device Research
Donna Headlee, RN, BSN, CCRP, Consumer Safety Officer
A clinical investigator's primary responsibilities are the protection of human subjects, supervising the conduct of the investigation, and ensuring the quality and integrity of the data. During this presentation, I will discuss various strategies to assist an investigator to build quality into device research. Some of these strategies include the concepts of: quality data, the data lifecycle, and quality studies; suggestions (what we refer to as helpful hints) for investigators to conduct Quality Studies; and a quality systems approach. Applying the strategies discussed in this presentation will assist an investigator to build quality into every step of device research.
Medical Device Reporting
MAUDE - Information Available to the Public
Eugene Reilly
This presentation describes the MAUDE and MDR databases.
Electronic Medical Device Reporting (eMDR)
Eugene Reilly
This presentation will cover the overall process of how to begin submitting electronically, and what you should expect after you begin submitting electronically.
Medical Device Reporting
Sharon Kapsch
This presentation is devoted to Medical Device Reporting and what that means.
MDR for User Facilities
Sharon Kapsch
This presentation is devoted to Medical Device Reporting and what that means for device user facilities.
MDR for Manufacturers and Importers
Sharon Kapsch
This presentation is devoted to Medical Device Reporting and what that means for device manufacturers and importers.
