Deciding When to Submit a New 510(k) for a Change to an Existing Device

To address some confusion surrounding the guidance Deciding When to Submit a New 510(k) for a Change to an Existing Device, the FDA has worked diligently to enhance predictability, consistency and transparency while maintaining a “least burdensome approach”. The new updated guidance provides greater detail of the regulatory framework, policies and practices underlying FDA’s decision-making process and provides much needed clarity for industry on FDA’s expectations.

In this course we walk through these changes and discuss how to determine when to submit.