838055
Inspection Details
- Classification
- Voluntary Action Indicated (VAI) (VAI)
- End Date
- July 1, 2013
- Fiscal Year
- 2013
- Product Type
- Devices
- Project Area
- Bioresearch Monitoring
- Location
- Minneapolis, MN (United States)
Additional Details
IRB
Citations
| ID | CFR | Description |
|---|---|---|
| 7281 | 21 CFR 56.108(a)(1) | Initial and continuing reviews |
| 7333 | 21 CFR 56.104(c) | Emergency use and IRB approval |
| 7337 | 21 CFR 56.115(b) | Retention of records |
| 7370 | 21 CFR 56.111(c) | Children as subjects |