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Title:The FDA De Novo Medical Device Pathway, Patents, and Anticompetition
Author(s):Sherkow, Jacob S.; Aboy, Mateo
Subject(s):FDA
de novo
medical devices
510(k)
patents
anticompetition
Abstract:The interaction between patents and FDA’s De Novo and 510(k) regulatory pathways has the potential to threaten follow-on innovation for medical devices.
Issue Date:2020-09-04
Publisher:Nature Portfolio
Citation Info:Jacob S. Sherkow & Mateo Aboy, The FDA De Novo Medical Device Pathway, Patents, and Anticompetition, 38 Nat. Biotech. 1028 (2020)
Genre:Article
Type:Text
Language:English
URI:http://hdl.handle.net/2142/110337
DOI:10.1038/s41587-020-0653-6
Date Available in IDEALS:2021-08-20


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