The 510(k) Submission: Requirements, Contents, and Options 2013

Key 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.