Post-market clinical research conducted by medical device manufacturers: a cross-sectional survey

Joseph S Ross, Katrina L Blount, Jessica D Ritchie, Beth Hodshon, Harlan M Krumholz Center for Outcomes Research and Evaluation, Yale-New Haven Hospital, New Haven, CT, USA Background: In the US, once a medical device is made available for use, several requirements have been established by the US F...

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Autores principales:	Ross JS, Blount KL, Ritchie JD, Hodshon B, Krumholz HM
Formato:	article
Lenguaje:	EN
Publicado:	Dove Medical Press 2015
Materias:	Medical technology R855-855.5
Acceso en línea:	https://doaj.org/article/09ded336d4994b24b225893800cd65e0
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spelling	oai:doaj.org-article:09ded336d4994b24b225893800cd65e02021-12-02T08:20:43ZPost-market clinical research conducted by medical device manufacturers: a cross-sectional survey1179-1470https://doaj.org/article/09ded336d4994b24b225893800cd65e02015-05-01T00:00:00Zhttp://www.dovepress.com/post-market-clinical-research-conducted-by-medical-device-manufacturer-peer-reviewed-article-MDERhttps://doaj.org/toc/1179-1470Joseph S Ross, Katrina L Blount, Jessica D Ritchie, Beth Hodshon, Harlan M Krumholz Center for Outcomes Research and Evaluation, Yale-New Haven Hospital, New Haven, CT, USA Background: In the US, once a medical device is made available for use, several requirements have been established by the US Food and Drug Administration (FDA) to ensure ongoing post-market surveillance of device safety and effectiveness. Our objective was to determine how commonly medical device manufacturers initiate post-market clinical studies or augment FDA post-market surveillance requirements for higher-risk devices that are most often approved via the FDA's pre-market approval (PMA) pathway. Methods and results: We conducted a cross-sectional survey of 47 manufacturers with operations in California, Minnesota, and Massachusetts who market devices approved via the PMA pathway. Among 22 respondents (response rate =47%), nearly all self-reported conducting post-market clinical research studies, commonly between 1 and 5; only 1 respondent reported never conducting post-market clinical research studies. While manufacturers most often engaged in these studies to satisfy FDA requirements, other reasons were reported, including performance monitoring and surveillance and market acceptance initiatives. Risks of conducting and not conducting post-market clinical research studies were described through open-ended response to questions. Conclusion: Medical device manufacturers commonly initiate post-market clinical studies at the request of the FDA. Clinical data from these studies should be integrated into national post-market surveillance initiatives. Keywords: FDA, PMA pathway, post-market surveillanceRoss JSBlount KLRitchie JDHodshon BKrumholz HMDove Medical PressarticleMedical technologyR855-855.5ENMedical Devices: Evidence and Research, Vol 2015, Iss default, Pp 241-249 (2015)
institution	DOAJ
collection	DOAJ
language	EN
topic	Medical technology R855-855.5
spellingShingle	Medical technology R855-855.5 Ross JS Blount KL Ritchie JD Hodshon B Krumholz HM Post-market clinical research conducted by medical device manufacturers: a cross-sectional survey
description	Joseph S Ross, Katrina L Blount, Jessica D Ritchie, Beth Hodshon, Harlan M Krumholz Center for Outcomes Research and Evaluation, Yale-New Haven Hospital, New Haven, CT, USA Background: In the US, once a medical device is made available for use, several requirements have been established by the US Food and Drug Administration (FDA) to ensure ongoing post-market surveillance of device safety and effectiveness. Our objective was to determine how commonly medical device manufacturers initiate post-market clinical studies or augment FDA post-market surveillance requirements for higher-risk devices that are most often approved via the FDA's pre-market approval (PMA) pathway. Methods and results: We conducted a cross-sectional survey of 47 manufacturers with operations in California, Minnesota, and Massachusetts who market devices approved via the PMA pathway. Among 22 respondents (response rate =47%), nearly all self-reported conducting post-market clinical research studies, commonly between 1 and 5; only 1 respondent reported never conducting post-market clinical research studies. While manufacturers most often engaged in these studies to satisfy FDA requirements, other reasons were reported, including performance monitoring and surveillance and market acceptance initiatives. Risks of conducting and not conducting post-market clinical research studies were described through open-ended response to questions. Conclusion: Medical device manufacturers commonly initiate post-market clinical studies at the request of the FDA. Clinical data from these studies should be integrated into national post-market surveillance initiatives. Keywords: FDA, PMA pathway, post-market surveillance
format	article
author	Ross JS Blount KL Ritchie JD Hodshon B Krumholz HM
author_facet	Ross JS Blount KL Ritchie JD Hodshon B Krumholz HM
author_sort	Ross JS
title	Post-market clinical research conducted by medical device manufacturers: a cross-sectional survey
title_short	Post-market clinical research conducted by medical device manufacturers: a cross-sectional survey
title_full	Post-market clinical research conducted by medical device manufacturers: a cross-sectional survey
title_fullStr	Post-market clinical research conducted by medical device manufacturers: a cross-sectional survey
title_full_unstemmed	Post-market clinical research conducted by medical device manufacturers: a cross-sectional survey
title_sort	post-market clinical research conducted by medical device manufacturers: a cross-sectional survey
publisher	Dove Medical Press
publishDate	2015
url	https://doaj.org/article/09ded336d4994b24b225893800cd65e0
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Post-market clinical research conducted by medical device manufacturers: a cross-sectional survey

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