_edited.jpg)
FDA Medical Device Regulations
Course Overview
​​​
-
Duration: 4 modules × 2 hours + 4 hours homework = 12 total hours
-
Target Audience: Regulatory affairs professionals, quality managers, US market entrants
-
Certificate: Professional Development Certificate of Completion
Learning Outcomes
Upon completion, participants will be able to:
​
-
Navigate FDA device classification and pathways
-
Understand premarket submission requirements
-
Implement Quality System Regulation (QSR)
-
Manage post-market obligations and reporting
Module 1:
FDA Device Classification and Pathways
(2 hours)
-
Device classification system (Class I, II, III)
-
510(k) premarket notification process
-
Premarket approval (PMA) requirements
-
De Novo classification pathway
-
Homework: Device classification and pathway determination exercise
Module 2:
remarket Submissions and Review
(2 hours)
-
510(k) submission preparation
-
Predicate device selection and comparison
-
Clinical data requirements
-
FDA review process and timelines
-
Homework: 510(k) submission outline development
Module 3:
Quality System Regulation (21 CFR 820)
(2 hours)
-
QSR requirements overview
-
Design controls implementation
-
Production and process controls
-
CAPA system requirements
-
Homework: Design control procedure development for FDA compliance
Module 4:
Post-Market Requirements and Inspections
(2 hours)
-
Medical device reporting (MDR)
-
FDA inspection preparation
-
483 observations and responses
-
Recall procedures and field actions
-
Homework: FDA inspection readiness checklist completion
