Food and Drug Administration (FDA) Current Good Manufacturing Practise cGMP
- United States Pharmacopea USP
Läkemedel
- 21 Code of federal regulations 21 CFR 200
- Investigational New Drug IND
- New Drug Application NDA
Medicintekniska produkter
- 21 Code of federal regulations 21 CFR 800
- Quality system regulations
- Investigational Device Exemption IDE
- Premarket Approval PMA
- Premarket Notification 510(K)