Table 1 Medical devices receiving marketing authorization fiscal year 2015 through fiscal year 2020 analyzed in this study, organized by CDRH OHT
From: Inclusion of patient-reported outcome instruments in US FDA medical device marketing authorizations
Office of health technology | PMA | 510 (k) | De Novo | HDE |
|---|---|---|---|---|
OHT 1 (ophthalmic/anesthesia/respiratory/ear nose & throat/dental devices) | 13% | 23% | 22% | 8% |
n = 35 | n = 47 | n = 17 | n = 1 | |
OHT 2 (cardiovascular devices) | 49% | 21% | 13% | 25% |
n = 131 | n = 42 | n = 10 | n = 3 | |
OHT 3 (reproductive/gastro-renal/urological/general hospital devices and human factors) | 7% | 14% | 23% | 33% |
n = 18 | n = 29 | n = 18 | n = 4 | |
OHT 4 (neurological/psychiatric/physical medicine devices) | 7% | 20% | 17% | 0% |
n = 19 | n = 40 | n = 13 | n = 0 | |
OHT 5 (neurological/physical medicine devices) | 7% | 10% | 18% | 8% |
n = 20 | n = 20 | n = 14 | n = 1 | |
OHT 6 (orthopedic devices) | 8% | 5% | 3% | 25% |
n = 21 | n = 11 | n = 2 | n = 3 | |
OHT 7 (in vitro diagnostics*/radiological health) | 9% | 6% | 5% | 0% |
n = 24 | n = 12 | n = 4 | n = 0 | |
Total | n = 268 | n = 201 | n = 78 | n = 12 |