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 Diadnostics (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