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

Why Should You Attend:

This Medical device training will provide an understanding of how to get a device requiring a 510(k) submission to market quickly. Knowing when and how to properly submit a 510(k) for a device or change to a device is critical to a company’s regulatory and financial health. Your goal is to get the 510(k) through the review process as quickly as possible. This presentation will also distinguish between the standard, special and abbreviated 510(k)s, and explain when each is appropriate. This course will describe the submission process and the contents required by the FDA for a successful submission. It will also provide an understanding of the common pitfalls, delays, and possible preventive measures. Also described will be the type of activities a company can pursue while waiting for submission clearance.

Areas Covered in the Seminar:

• When to submit a 510(k) for a new or modified product.
• Types of 510(k) submissions and when to use each.
• What is the submission process.
• What is contained in a 510(k) submission package.
• How to know whether clinical data is required.
• How is the submission package assembled.
• User fees and 510(k) submissions.
• How to interact with the FDA and the reviewer.
• What to do if you make a change to your device.

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

Instructor Profile:

Jeff Kasoff, RAC, is the Director of Quality at Medivators, a leading manufacturer of endoscopy consumables and instrumentation. In this position, Jeff is responsible for oversight of the quality system, including the CAPA program, and is the liaison with FDA. For the previous 13 years, Jeff served as Director of Regulatory Affairs at Life-Tech, Inc., in which capacity he was similary responsible for quality system oversight. Jeff began his regulatory career as the first full-time employee of Optex Biomedical, a device start-up, where he initiated their regulatory policies and procedures and prepared their submissions. Jeff received his Regulatory Affairs Certification in 1996.

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