Avoiding a catch-22

Dykema’s Tania Shapiro-Barr and Mark Mansour explore how to navigate FDA approval and patent protection in the medical device world

Tania Shapiro-Barr and Mark Mansour - Dykema

Regulatory approval and patent protectionare key milestones for the success of any medical device. While most applicants have an understanding of the US Food and DrugAdministration’s (FDA) 510(k) regulatory pathway for the clearance of medicaldevices, there is less information available regarding how to avoid commonpitfalls during the process. This section will discuss some of these, with tipson how to avoid them.