FDA Training and Continuing Education Courses

CDRH Course Home page

CDRH Learn Course List (English)

Overview of Regulatory Requirements: Medical Devices

Quality System Regulation 21 CFR Part 820 Basic Introduction

Introduction to Medical Device Recalls: Industry Responsibilities

Device Establishment Registration and Listing

Overview of the Premarket Notification Process – 510(k)

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


CE Article, 1999: Improving Patient Care by Reporting Problems with Medical Devices (pdf)