What does this research mean for the field?

The FDA's 510(k) medical device clearance process should transition from requiring substantial equivalence to requiring substantial improvement. Novelty: ClaimNovelty.SYNTHESIS. Consensus alignment: ConsensusAlignment.NEUTRAL.

August 1, 2019

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

Q: What is the clinical evidence from this study?

Study design: Editorial. Population: Medical devices (510(k) pathway). Intervention: 510(k) device regulation.

Key Result

The article discusses moving from substantial equivalence to substantial improvement for 510(k) medical devices.

PICO

Population

Medical devices (510(k) pathway)

Intervention / Comparator

510(k) device regulation

Abstract

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Cite This Study

Redberg et al. (Thu,) conducted a editorial in Medical devices (510(k) pathway). 510(k) device regulation was evaluated. The article discusses moving from substantial equivalence to substantial improvement for 510(k) medical devices.

synapsesocial.com/papers/6a19f30805af093a17f6c997 https://doi.org/https://doi.org/10.1001/jama.2019.10191