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