Chapter 82 - Medical device pathways

Abstract

This chapter provides an overview of medical device approval in the United States. It starts with an overview of the device classification system established by the Food and Drug Administration (FDA) and the Food, Drug, and Cosmetic Act. It then talks about the different pathways for device approval including FDA exempt devices, premarket notification, premarket approval, de novo review, and the humanitarian device exemption. The discussion of each pathway details the purpose of the pathway and the required materials that need to be submitted to the FDA including important considerations about the FDA review process. Finally, FDA recommendations regarding the steps required to get a device approved are outlined and explained. The discussion of approval pathways is highlighted with real-life examples to provide context.