ISSN 0377-9556 (PRINT)
ISSN 2383-9457 (ONLINE)
ISSN 2383-9457 (ONLINE)
Identified risk and mitigation measures of EndeavorRx15)
| Identified risk | Mitigation measures |
|---|---|
| Ineffective treatment leading to worsening or uncontrolled symptoms | • Labeling • Clinical performance testing |
| Device software failure leading to delayed access | • Labeling • Software verification and validation |
| Treatment results in frustration, emotional reaction, dizziness, nausea, headache, eye-strain, or joint pain | • Labeling • Clinical performance testing • Software verification, validation, and hazard analysis |
| Treatment results in seizure | • Labeling • Clinical performance testing |
| Treatment results in screen addiction | • Labeling • Clinical performance testing |
| Treatment results in decreased sleep quality | • Labeling • Clinical performance testing |