Skip to main content
Fig. 1 | Journal of Patient-Reported Outcomes

Fig. 1

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

Fig. 1

PRO inclusion in summary documents fiscal year 2015- fiscal year 2020. The 510(k) cohort consisted of cleared 510(k)s that included clinical trial data. The majority of De Novos granted in fiscal year 2020 did not have summary documents posted within the study window leading to the low n observed. There were no HDE approvals publicly posted in fiscal year 2020. FY = Fiscal year

Back to article page