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.
Journal Information
Full Title: NPJ Digit Med
Abbreviation: NPJ Digit Med
Country: Unknown
Publisher: Unknown
Language: N/A
Publication Details
Subject Category: Medical Informatics
Available in Europe PMC: Yes
Available in PMC: Yes
PDF Available: No
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"Competing interests The authors declare no competing interests."
"MA’s research for this work was supported, in part, by a Novo Nordisk Foundation Grant for a scientifically independent International Collaborative Bioscience Innovation & Law Programme (Inter-CeBIL programme—grant no. NNF23SA0087056)."
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Last Updated: Aug 05, 2025