Moving From Substantial Equivalence to Substantial Improvement for 510(k) Devices

Redberg, RF; Dhruva, SS

Redberg, RF (reprint author), UCSF, Sch Med, Core Fac, Philip R Lee Inst Hlth Policy Studies, 505 Parnassus Ave,Ste M-1180, San Francisco, CA 94143 USA.

JAMA-JOURNAL OF THE AMERICAN MEDICAL ASSOCIATION, 2019; 322 (10): 927

Abstract

This Viewpoint reviews the FDA's 510(k) premarket review pathway through which many medical devices are brought into the US market based on substantia......

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