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.

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.

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.