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2023•BMJ Surgery Interventions & Health TechnologiesOpen access

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

Vinay Kumar Rathi, James L. Johnston, Sanket Shishir Dhruva, Joseph S. Ross

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Abstract

The US Food and Drug Administration (FDA) regulates high-risk medical devices through the premarket approval (PMA) pathway, which requires clinical evidence assuring safety and effectiveness for approval.[1][1] After approval, manufacturers may face barriers to successful commercialization, such as

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What this paper is about

The US Food and Drug Administration (FDA) regulates high-risk medical devices through the premarket approval (PMA) pathway, which requires clinical evidence assuring safety and effectiveness for approval.[1][1] After approval, manufacturers may face barriers to successful commercialization, such as

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Available abstract

The US Food and Drug Administration (FDA) regulates high-risk medical devices through the premarket approval (PMA) pathway, which requires clinical evidence assuring safety and effectiveness for approval.[1][1] After approval, manufacturers may face barriers to successful commercialization, such as

Key concepts: Food and drug administration, Commercialization, Drug approval, Business, Competition (biology), Medical device, Medicine, Drug

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