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PubMed

A Framework for Incorporating Patient Preferences Regarding Benefits and Risks into Regulatory Assessment of Medical Technologies.

PMID: 27712701 ·

Martin Ho, Anindita Saha, K Kimberly McCleary, Bennett Levitan, Stephanie Christopher, Kristen Zandlo, R Scott Braithwaite, A Brett Hauber, Medical Device Innovation Consortium’s Patient Centered Benefit-Risk Steering Committee

JournalValue in health : the journal of the International Society for Pharmacoeconomics and Outcomes Research
Year
PMID27712701

Abstract

In response to 2012 guidance in which the US Food and Drug Administration's (FDA) Center for Devices and Radiological Health (CDRH) stated the importance of patient-centric measures in regulatory benefit-risk assessments, the Medical Device Innovation Consortium (MDIC) initiated a project. The project was used to develop a framework to help the Food and Drug Administration (FDA) and industry sponsors understand how patient preferences regarding benefit and risk might be integrated into the revie

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