Fig. 2
From: Inclusion of patient-reported outcome instruments in US FDA medical device marketing authorizations
Inclusion of PRO in summary documents, separated by endpoint positioning. Summary documents were grouped by device authorization pathway (premarket approval (PMA), premarket notification [510(k)], Device Classification Under Sect. 510(f) [2] (De Novo), Humanitarian Device Exemption (HDE)). Percentage of marketing authorizations that included a PRO in the summary documents (total bar), separated by the marketing authorizations that used at least one PRO as a primary or secondary endpoint (orange) and those that included PROs as supporting data, either to support ancillary endpoints or without specifying endpoint positioning (blue)