Training and Continuing Education

CDRH Learn Course List (Chinese)

Listed below are the learning modules that CDRH currently offers in Mandarin Chinese.

Overview of Regulatory Requirements: Medical Devices
Video   Printable Slides   Transcript

Premarket Notification (510k)

Premarket Notification 510(k) Overview
Video   Printable Slides   Transcript

510(k) Format Guidance, Including Standards Form, and Extensions/Clinical Trial Form and 510(k)
Video   Printable Slides   Transcript

510(k) User Fees
Video   Printable Slides   Transcript

510(k) Third Party Review
Video   Printable Slides   Transcript

"513(g)s" Including 513(g) User Fees
Video   Printable Slides   Transcript

Product Codes Making the Connection
Video   Printable Slides   Transcript


Bioresearch Monitoring (BIMO)

BIMO Part 1a - Good Clinical Practice 101: An Introduction
Video

BIMO Part 1b - Introduction to the Bioresearch Monitoring Program
Video   Printable Slides   Transcript

BIMO Part 2a - The Sponsor: Responsibilities in Medical Device Clinical Trials
Video   Printable Slides   Transcript

BIMO Part 2b - The Clinical Investigator: Responsibilities in Medical Device Trials
Video   Printable Slides   Transcript

BIMO Part 2c - Computerized Systems Used in Medical Device Clinical Investigations
Video

BIMO Part 3a - Institutional Review Board: Responsibilities in Making the Significant Risk and Non-significant Risk Device Determination
Video   Printable Slides   Transcript

BIMO Part 3b - Institutional Review Board: Humanitarian Use Devices (HUDs)
Video   Printable Slides   Transcript

BIMO Part 3c - Institutional Review Board: Compassionate and Emergency Use
Video   Printable Slides   Transcript

BIMO Part 4a - Preparing for an FDA Medical Device Sponsor Inspection
Video

BIMO Part 4b - Preparing for an FDA Clinical Investigator Inspection
Video

BIMO Part 4c - Preparing for an FDA Institutional Review Board Inspection
Video

BIMO Part 5a - Strategies for Sponsors to Build Quality into Device Research
Video   Printable Slides   Transcript

BIMO Part 5b - Strategies For Clinical Investigators to Build Quality into Device Research
Video   Printable Slides   Transcript

Start here! Quality System Regulation Overview
Video   Transcript


Medical Device Reporting (MDR)

MAUDE - Information Available to the Public
Video

Electronic Medical Device Reporting (eMDR)
Video

Medical Device Reporting
Video

MDR for User Facilities
Video

MDR for Manufacturers and Importers
Video

 

Page Last Updated: 06/18/2014
Note: If you need help accessing information in different file formats, see Instructions for Downloading Viewers and Players.