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