Inclusion of patient-reported outcome instruments in US FDA medical device marketing authorizations

BACKGROUND: The U.S. Food and Drug Administration encourages the incorporation of the patient voice throughout the medical device total product lifecycle. This study examined the incorporation of patient-reported outcome (PRO) instruments in the evaluation of medical devices over a six-year period....

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Detalles Bibliográficos
Autores principales: Matts, Sophia T., Webber, Christina M., Bocell, Fraser D., Caldwell, Brittany, Chen, Allen L., Tarver, Michelle E.
Formato: Online Artículo Texto
Lenguaje:English
Publicado: Springer International Publishing 2022
Materias:
Research
Acceso en línea:https://www.ncbi.nlm.nih.gov/pmc/articles/PMC9021347/
https://www.ncbi.nlm.nih.gov/pubmed/35441987
http://dx.doi.org/10.1186/s41687-022-00444-z

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