Regulatory Links

Product Category Definitions

Definitions of biological product, drug, device and combination products

Small Molecule Drugs

Center for Drug Evaluation & Research (CDER) home page


Center for Biologic Evaluation & Research (CBER) home page

CBER guidance and guidelines

Investigational new drug (IND) details and guidance documents

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

Still can’t find what you are looking for? Try this last group of links:

Broad Search Categories

Code of Federal Regulations Title 21, 800-900 in particular

Search of all databases

Food and Drug Cosmetic Act (US)

International Clinical Harmonization (ICH) – caution this is not US specific

Device recalls