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

Sophia T Matts; Christina M Webber; Fraser D Bocell; Brittany Caldwell; Allen L Chen; Michelle E Tarver

doi:10.1186/s41687-022-00444-z

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

J Patient Rep Outcomes. 2022 Apr 20;6(1):38. doi: 10.1186/s41687-022-00444-z.

Authors

Sophia T Matts¹, Christina M Webber², Fraser D Bocell², Brittany Caldwell², Allen L Chen², Michelle E Tarver³

Affiliations

¹ Oak Ridge Institute for Science and Education (ORISE) Research Participation Program, Center for Devices and Radiological Health, U.S. Food and Drug Administration, Silver Spring, MD, USA.
² Center for Devices and Radiological Health, U.S. Food and Drug Administration, 10903 New Hampshire Ave, Silver Spring, MD, 20993, USA.
³ Center for Devices and Radiological Health, U.S. Food and Drug Administration, 10903 New Hampshire Ave, Silver Spring, MD, 20993, USA. michelle.tarver@fda.hhs.gov.

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 period. PRO instruments used to inform study endpoints were extracted from the summary documents and clinical trial data of premarket authorizations posted on publicly available FDA databases between October 1, 2014-September 30, 2020.

Results: PROs were included in 53% of authorizations, with 34% using PROs as primary and secondary endpoints. This study found that PRO instruments were used in each type of marketing authorization and in all medical specialties examined in this study.

Conclusions: Expanding the current collaborative efforts to develop and modify PRO instruments may help to improve use of PROs in medical device evaluations.