Federal Regulations
- 45 CFR 46: DHHS Protection of Human Subjects
- 21 CFR 50: FDA Protection of Human Subjects
- 21 CFR 56: FDA Regulation of IRBs
- 21 CFR 312: FDA Investigational New Drug Application
- 21 CFR 812: FDA Investigational Device Exemptions
- 45 CFR 160 & 164: HIPPA Privacy Rule
- 45 CFR 160, 162, & 164: HIPPA Security Rule
- 21 CFR 11: FDA Electronic Records, Electronic Signatures
- FDA Regulations Relating to Good Clinical Practice and Clinical Trials
Seton is proud to have four hospitals – the only hospitals in Central Texas - that have earned the