FDA Approval Process for Medical Devices provides a comprehensive overview of the FDA approval process for medical devices, covering submission types, regulatory requirements, and strategies for successful approval.
Topics
Application contents, review processes, and timelines for 510(k), IDE, PMA, HDE, and De Novo submissions
FDA processes for premarket submissions
Understanding the overall FDA medical device regulatory process
Key guidance documents for medical device submissions
Pre-submission process and its importance
Device classification, establishment registration, and device listing
Recent changes in legislation, regulations, and guidance
Case studies for applying learning and using FDA databases
Who should Attend
Regulatory professionals in the medical device industry
Quality assurance and clinical professionals
Legal and management professionals interested in FDA processes
Marketing and medical professionals looking to understand approval procedures
Technical professionals involved in medical device development
