993321
Inspection Details
- Classification
- Official Action Indicated (OAI) (OAI)
- End Date
- October 25, 2016
- Fiscal Year
- 2017
- Product Type
- Devices
- Project Area
- Bioresearch Monitoring
- Location
- Las Vegas, NV (United States)
Additional Details
IRB
Citations
| ID | CFR | Description |
|---|---|---|
| 7316 | 21 CFR 56.115(a)(4) | Copies of IRB/CI correspondence |
| 7334 | 21 CFR 56.115(a)(5) | List of members |
| 7335 | 21 CFR 56.115(a)(6) | Written procedures per 56.108(a) and (b) |
| 7352 | 21 CFR 50.51 | Provisions for soliciting assent and permission |
| 7388 | 21 CFR 50.25(a)(2) | Reasonably foreseeable risks or discomforts |
| 7389 | 21 CFR 50.25(a)(3) | Benefits to the subject |
| 7390 | 21 CFR 50.25(a)(4) | Alternate procedures, courses of treatment |
| 7679 | 21 CFR 56.106(a) | IRB for CI's in support of research/marketing permits |