Clinical Evidence Supporting US Food and Drug Administration Clearance of Novel Therapeutic Devices via the De Novo Pathway Between 2011 and 2019.

JAMA Intern Med

Department of Otolaryngology-Head and Neck Surgery, Massachusetts Eye and Ear Infirmary, Boston.

Published: December 2020

This cross-sectional study characterizes the premarket clinical evidence supporting clearance of moderate-risk novel therapeutic medical devices by the US Food and Drug Administration.

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Source
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7551221PMC
http://dx.doi.org/10.1001/jamainternmed.2020.3214DOI Listing

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