Training and Continuing Education

CDRH Learn Course List (Spanish)

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

Overview of Regulatory Requirements: Medical Devices
Video   Printable Slides   Transcript

Premarket Notification (510k)

Premarket Notification 510(k) Overview
Video

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

510(k) User Fees
Video

510(k) Third Party Review
Video   Printable Slides

"513(g)s" Including 513(g) User Fees
Video

Product Codes Making the Connection
Video


Bioresearch Monitoring (BIMO)

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

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

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

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

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

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

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

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

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

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

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

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

Start here! Quality System Regulation Overview
Video   Transcript


Medical Device Recalls

Introduction to Medical Device Recalls: Industry Responsibilities (Spanish audio only)
Video   Printable Slides   Transcript

Recall Module 21 CFR Part 806: Medical Devices; Reports of Corrections and Removals (Spanish audio only)
Video   Printable Slides   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

Export Certificates for Medical Devices
Video   Printable Slides   Transcript

How to Get Your Electronic Product on the U.S. Market (Spanish audio only)
Video   Printable Slides   Transcript

Page Last Updated: 06/18/2014
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