Regulatory Submission Characteristics and Recalls of Medical Devices Receiving 510(k) Clearance-Reply

Alexander O. Everhart; Yi Zhu; Ariel D. Stern

doi:10.1001/jama.2023.4095

Regulatory Submission Characteristics and Recalls of Medical Devices Receiving 510(k) Clearance-Reply

Alexander O. Everhart
, Yi Zhu
, Ariel D. Stern

Research output: Contribution to journal › Letter › peer-review

Original language	English
Pages (from-to)	1609-1610
Number of pages	2
Journal	JAMA
Volume	329
Issue number	18
DOIs	https://doi.org/10.1001/jama.2023.4095
State	Published - May 9 2023

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10.1001/jama.2023.4095

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title = "Regulatory Submission Characteristics and Recalls of Medical Devices Receiving 510(k) Clearance-Reply",

author = "Everhart, \{Alexander O.\} and Yi Zhu and Stern, \{Ariel D.\}",

note = "Funding Information: Conflict of Interest Disclosures: Dr Everhart reported prior employment with Medtronic; receiving personal fees from the Digital Medicine Society and the University of Southern California; and receiving grant funding from the Agency for Healthcare Research and Quality, the National Institute on Aging, and the National Bureau of Economic Research. Dr Stern reported serving on the scientific advisory board of the German Society for Digital Medicine and on the strategic advisory board of HumanFirst and receiving personal fees from the US Department of Health and Human Services. No other disclosures were reported. ",

year = "2023",

month = may,

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doi = "10.1001/jama.2023.4095",

language = "English",

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T1 - Regulatory Submission Characteristics and Recalls of Medical Devices Receiving 510(k) Clearance-Reply

AU - Everhart, Alexander O.

AU - Zhu, Yi

AU - Stern, Ariel D.

N1 - Funding Information: Conflict of Interest Disclosures: Dr Everhart reported prior employment with Medtronic; receiving personal fees from the Digital Medicine Society and the University of Southern California; and receiving grant funding from the Agency for Healthcare Research and Quality, the National Institute on Aging, and the National Bureau of Economic Research. Dr Stern reported serving on the scientific advisory board of the German Society for Digital Medicine and on the strategic advisory board of HumanFirst and receiving personal fees from the US Department of Health and Human Services. No other disclosures were reported.

PY - 2023/5/9

Y1 - 2023/5/9

UR - https://www.scopus.com/pages/publications/85159046378

U2 - 10.1001/jama.2023.4095

DO - 10.1001/jama.2023.4095

M3 - Letter

C2 - 37159037

AN - SCOPUS:85159046378

SN - 0098-7484

VL - 329

SP - 1609

EP - 1610

JO - JAMA

JF - JAMA

IS - 18

ER -

Regulatory Submission Characteristics and Recalls of Medical Devices Receiving 510(k) Clearance-Reply

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