Market competition among manufacturers of novel high-risk therapeutic devices receiving FDA premarket approval between 2001 and 2018.

Abstract

© Author(s) (or their employer(s)) 2023. Reuse permitted under CC BYNC. No commercial reuse. See rights and permissions. Published by BMJ. INTRODUCTION The US Food and Drug Administration (FDA) regulates highrisk medical devices through the premarket approval (PMA) pathway, which requires clinical evidence assuring safety and effectiveness for approval. After approval, manufacturers may face barriers to successful commercialization, such as uncertainties about reimbursement or limited market exclusivity. 3 These clinical, financial and operational hurdles may discourage market entry by manufacturers, thereby limiting competitive innovation. We sought to evaluate the extent of market entry by manufacturers of firstinclass devices and subsequent competitors.