Nothing Generic About It: Promoting Therapeutic Access by Overcoming Regulatory and Legal Barriers to a Robust Generic Medical Device Market
35 Pages Posted: 1 May 2020
Date Written: 2020
This Article addresses a paradox in American healthcare technology: a thriving market for generic drugs but a paucity of generic medical devices. Despite the success of generic pharmaceuticals in reducing healthcare costs, no analogous market exists for generic medical devices. This plays a part in keeping prices high while limiting access to affordable therapies. In this Article, we highlight the regulatory and legal barriers currently impeding the development of a generic medical device market in the United States. We explore differences between generic drugs and generic devices in FDA regulation, products liability, and patentability, all of which contribute to the absence of medical devices in clinical practice. We conclude with recommendations to foster more widespread development of generic medical devices.
Keywords: FDA, generic drugs, medical devices, products liability, patentability
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