Table 2 Percentage of PMA approvals that included PRO instruments by fiscal year
From: Inclusion of patient-reported outcome instruments in US FDA medical device marketing authorizations
| Â | OHT 1 | OHT 2 | OHT 3 | OHT 4 | OHT 5 | OHT 6 | OHT 7 |
|---|---|---|---|---|---|---|---|
Fiscal year 2015 | 100% | 52% | 100% | 100% | 67% | 100% | 0% |
|  | n = 5 | n = 23 | n = 4 | n = 6 | n = 3 | n = 5 | n = 4 |
Fiscal year 2016 | 83% | 30% | 100% | 100% | 100% | 100% | 14% |
|  | n = 6 | n = 27 | n = 4 | n = 3 | n = 4 | n = 5 | n = 7 |
Fiscal year 2017 | 100% | 52% | 100% | 75% | 50% | 100% | 0% |
|  | n = 5 | n = 25 | n = 1 | n = 4 | n = 2 | n = 2 | n = 4 |
Fiscal year 2018 | 89% | 29% | 50% | 50% | 50% | 100% | 29% |
|  | n = 9 | n = 17 | n = 2 | n = 4 | n = 4 | n = 3 | n = 7 |
Fiscal year 2019 | 100% | 63% | 80% | Â | 50% | 100% | 0% |
|  | n = 5 | n = 24 | n = 5 | n = 0 | n = 4 | n = 4 | n = 1 |
Fiscal year 2020 | 40% | 27% | 100% | 100% | 67% | 100% | 0% |
|  | n = 5 | n = 15 | n = 2 | n = 2 | n = 3 | n = 2 | n = 1 |
Fiscal year 2015-Fiscal year 2020 average | 85% | 42% | 88% | 85% | 64% | 100% | 7% |
|  | n = 35 | n = 131 | n = 18 | n = 19 | n = 20 | n = 21 | n = 24 |