The FDA De Novo Medical Device Pathway, Patents, and Anticompetition
Sherkow, Jacob S.; Aboy, Mateo
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https://hdl.handle.net/2142/110337
Description
Title
The FDA De Novo Medical Device Pathway, Patents, and Anticompetition
Author(s)
Sherkow, Jacob S.
Aboy, Mateo
Issue Date
2020-09-04
Keyword(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.
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