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.

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 Session :

• 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 Should Attend:

• Research & Development Departments
• Engineering Departments
• Quality Assurance Departments
• Regulatory Affairs Departments
• New Product Development
• Marketing Departments
• Mid-level and Senior Management
• Project Leaders
• Professionals involved with premarket notification to the FDA
• Consultants

Course Director: JEFF KASOFF

Jeff Kasoff, RAC, CMQ/OE, LBB, is the Principal at Lean to Quality, LLC. He has more than 30 years in Quality and Regulatory management. Over that time, Jeff has implemented and overseen quality system operations and assured compliance, at all sizes of company, from startup to more than $100 million in revenue. This multi-faceted experience makes Jeff uniquely qualified to address compliance issues across the entire range of company sizes. Jeff has also been primary liaison with FDA inspectors and notified body auditors, giving him first-hand experience with the most common issues surfaced by regulatory agencies. Jeff has the following certifications: Manager of Quality and Organizational Excellence certification from ASQ, Regulatory Affairs Certification from RAPS, and Lean Black Belt from IIE.