Food and Drug Administration FDA
Current Good Manufacturing Practice cGMP
United States Pharmacopea USP
Productos Medicinales
21 Code of federal regulations 21 CFR
Part 200
- Investigational New Drug IND
- New Drug Application NDA
Dispositivos Médicos
21 Code of federal regulations 21 CFR
Part 800
- Investigational Device Exemption IDE
- Premarket Approval PMA
- Premarket Notification 510(K)