Beyond the 510(k): The regulation of novel moderate-risk medical devices, intellectual property considerations, and innovation incentives in the FDA's De Novo pathway

Mateo Aboy, Cristina Crespo, Ariel Stern. Beyond the 510(k): The regulation of novel moderate-risk medical devices, intellectual property considerations, and innovation incentives in the FDA's De Novo pathway. npj Digit. Medicine, 7(1), 2024. [doi]

Abstract

Abstract is missing.