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

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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Bibliographische Detailangaben
Veröffentlicht in:	Archives of internal medicine (1960) 2020-12, Vol.180 (12), p.1701-1703
Hauptverfasser:	Johnston, James L, Dhruva, Sanket S, Ross, Joseph S, Rathi, Vinay K
Format:	Artikel
Sprache:	eng
Schlagworte:	Cross-Sectional Studies Device Approval - standards Drug delivery systems Equipment and Supplies - standards Equipment Safety - standards Health Care Policy and Law Humans Letters Online First Product Surveillance, Postmarketing - standards Research Letter Studies United States United States Food and Drug Administration
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Beschreibung
Zusammenfassung:	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.
ISSN:	2168-6106 2168-6114
DOI:	10.1001/jamainternmed.2020.3214