Regulatory Links
› Product Category Definitions
Definitions of biological product, drug, device and combination products.
- Biological Product › Section 351(a) of the Public Health Service Act [42 U.S.C. 262(i)] and 21 CFR 600.3(h)
- Drug › Section 201(g) of the Federal Food, Drug, and Cosmetic Act { 21 U.S.C. 321(g) }
- Device › Section 201(h) of the Federal Food, Drug, and Cosmetic Act { 21 U.S.C. 321(h) }
- Combination Product › Section 503(g) of the Federal Food, Drug, and Cosmetic Act { 21 U.S.C 353 (g) } and { 21 CFR Part 3.2(e) }
› Small Molecule Drugs
› Biologics
- Center for Biologic Evaluation & Research (CBER) home page
- CBER guidance and guidelines
- Investigational new drug (IND) details and guidance document
› Medical Devices
- Device advice
- Information on exempt devices at the Centre for Device & Radiologic Health (CDRH)
- List of exempt devices
- Classifying a device
- Device classification database
- 510K guidance (‘substantial equivalence’)
- PMA guidance
› Combination Products
› Assays & In Vitro Diagnostics (IVD)
› Life Science Software
- Software guidance document for validation
- Guidance on Smartphone applications in a healthcare setting
› If you can't find what you are looking for, try using these broad search categories:
- Code of Federal Regulations Title 21, 800-900 in particular
- Search of all database
- Food and Drug Cosmetic Act (US)
- International Clinical Harmonization (ICH) { Caution: this is not US-specific }
- Device recall