Topics
- Types of 510(k) submissions and when to use each
- When to submit a 510(k) for a new or modified product
- What is contained in a 510(k) submission package
- What is the submission process
- How is the submission package assembled
- How to know whether clinical data is required
- How to interact with the FDA and the reviewer
- User fees and 510(k) submissions
- What to do if you make a change to your device
Who should Attend
Attendees from medical device companies, including Regulatory management, Executive management, R&D personnel involved in approving the design of medical devices, Professionals involved with premarket notification to the FDA and Sales personnel involved in approving the marketing of medical devices.
