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PubMed

Patient-reported outcomes and medical device evaluation: from conception to implementation.

PMID: 35608682 ·

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RevistaJournal of patient-reported outcomes
Ano
PMID35608682

Resumo

The insights gleaned from patient-reported outcomes (PROs) have implications across the healthcare ecosystem, from clinical investigations to evaluate the safety and effectiveness of medical devices to clinical care and reimbursement decisions. The U.S. Food and Drug Administration's (FDA) Center for Devices and Radiological Health (CDRH) hosted a public meeting in September 2020 discussing how PROs can be used in medical device evaluation throughout the total product life cycle, as well as meth

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