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The FDA De Novo medical device pathway, patents and anticompetition.
Nature Biotechnology ( IF 33.1 ) Pub Date : 2020-09-04 , DOI: 10.1038/s41587-020-0653-6
Jacob S Sherkow 1, 2, 3 , Mateo Aboy 4, 5
Affiliation  

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.

中文翻译:

FDA De Novo医疗器械途径,专利和反竞争。

专利与FDA的De Novo和510(k)监管途径之间的相互作用有可能威胁到医疗器械的后续创新。
更新日期:2020-09-05
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