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

• Autori principali: Sophia T. Matts (Autore), Christina M. Webber (Autore), Fraser D. Bocell (Autore), Brittany Caldwell (Autore), Allen L. Chen (Autore), Michelle E. Tarver (Autore)
• Natura: Libro
• Pubblicazione: SpringerOpen, 2022-04-01T00:00:00Z.
• Soggetti: article
• Accesso online: Connect to this object online.

Abstract 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...