HOW TO DECIDE WHEN A MODIFIED DEVICE REQUIRES A 510(K) CLEARANCE

Determining when a modification to a legally marketed device triggers the need for a 510(k) is challenging. Industry practice and FDA’s expectations are frequently not aligned. This is evidenced by an uptick in FDA Warning Letters regarding design and claims-related changes to medical devices. The following presentation will:

• Describe the FDA legal and regulatory framework governing the 510(k) implications of device modifications.
• Analyze the recent Warning Letters on this issue and provide insights into FDA’s current thinking.
• Outline the common pitfalls that industry encounters when evaluating device modifications, and provide a step-wise process for analyzing changes to 510(k)-cleared devices and 510(k)-exempt devices consistent with FDA’s expectations.

Speakers:
Pamela Forrest
Partner
King and Spalding

Lynette Zentgraft
Consultant
King and Spalding

Contact:

Brooke Akins | Manager, Market Intelligence | 312.224.1693 webinars@q1productions.com