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
