Objectives

Reviews the basic steps in development and Food and Drug Administration approval of medical devices, and summarizes post-marketing processes for drugs and devices.

Description

Drug and device approval pathways share common characteristics ,Each has special pre-submission opportunities for collaboration with the FDA. Each has 3 main pathways to approval. For each there is a main pathway requiring significant clinical evidence of efficacy and safety (the Investigational New Drug Application and the PMA, respectively), and a pathway for emergency use (the emergency investigational new drug and the Emergency Use notification, respectively). Deciding which path to initiate is only the first of a series of challenges that face the investigator. Early and regular communication with the FDA is encouraged to avoid pitfalls and problems that may waste time and resources.