October 12, 2020Open Access

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

Key Points

Key points are not available for this paper at this time.

Abstract

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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Authors

James L. Johnston

Sanket S. Dhruva

Joseph S. Ross

Journals

JAMA Internal Medicine

Actions

Institutions

Yale University

University of California, San Francisco

San Francisco VA Medical Center

References and Citations

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

Key Points

Abstract

Citation Network

Connected Papers

Discussion

Authors

Journals

Actions

Institutions

References and Citations

Citation Network

Connected Papers

Discussion

Cite this study