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

• Center for Drug Evaluation & Research (CDER) home page

› 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

• Office of Combination Products (OCP)

› Assays & In Vitro Diagnostics (IVD)

• In vitro diagnostics (OIVD/CDRH) List of approved classified IVDs
• Assignment of CLIA categories

› 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