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

This 510(k) training will discuss the submission process and the contents required by the FDA for a successful 510(k) submission. It will also provide an understanding of the common pitfalls, delays, and possible preventive measures.

Who will Benefit:

This webinar will provide valuable assistance to all medical device companies that prepare 510(k) submissions. The employees who will benefit include:

- Executive management
- Regulatory management
- Professionals involved with premarket notification to the FDA
- R&D personnel involved in approving the design of medical devices
- Sales personnel involved in approving the marketing of medical devices

Jeff Kasoff, RAC, is the Director of Regulatory Affairs at Life-Tech, Inc., a leading manufacturer of consumables and instrumentation in the urodynamic and pain management fields. Jeff is responsible for oversight of corporate compliance with domestic and international regulations, preparation of submissions, and is primary liaison with regulatory agencies and notified bodies.

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