推动510(k) 医疗器械从实质等同迈向实质改进。 - Suppr

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超能文献

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

作者信息

Redberg Rita F, Dhruva Sanket S

机构信息

UCSF School of Medicine, San Francisco, California.

Philip R. Lee Institute for Health Policy Studies, San Francisco, California.

出版信息

JAMA. 2019 Sep 10;322(10):927-928. doi: 10.1001/jama.2019.10191.

DOI:10.1001/jama.2019.10191

PMID:31355877

Abstract

摘要

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