Early experience with the FDA's Breakthrough Devices program

被引：26

作者：

Johnston, James L. ^{[1
]}

Dhruva, Sanket S. ^{[2
,3
]}

Ross, Joseph S. ^{[4
,5
,6
]}

Rathi, Vinay K. ^{[7
]}

机构：

[1] Yale Univ, Sch Med, New Haven, CT USA

[2] San Francisco VA Med Ctr, San Francisco, CA USA

[3] Univ Calif San Francisco, Sch Med, Dept Med, San Francisco, CA USA

[4] Yale New Haven Med Ctr, Ctr Outcomes Res & Evaluat CORE, 20 York St, New Haven, CT 06504 USA

[5] Yale Univ, Sch Med, Dept Epidemiol & Publ Hlth, Sect Hlth Policy & Adm, New Haven, CT 06510 USA

[6] Yale Univ, Sch Med, Dept Internal Med, Gen Internal Med Sect, New Haven, CT 06510 USA

[7] Massachusetts Eye & Ear Infirm, Dept Otolaryngol Head & Neck Surg, Boston, MA 02114 USA

来源：

NATURE BIOTECHNOLOGY | 2020年 / 38卷 / 08期

基金：

美国国家卫生研究院;

关键词：

PREMARKET APPROVAL; MEDICAL DEVICES; UNITED-STATES;

D O I：

10.1038/s41587-020-0636-7

中图分类号：

Q81 [生物工程学（生物技术）]; Q93 [微生物学];

学科分类号：

071005 ; 0836 ; 090102 ; 100705 ;

摘要：

引用

页码：933 / 938

页数：6

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