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

The FDA is aware of some confusion surrounding the guidance, Deciding When to Submit a New 510(k) for a Change to an Existing Device. As such, FDA has worked diligently over the past few years 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.