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
www.fda.gov/cder/

Biologics

Center for Biologic Evaluation & Research (CBER) home page
www.fda.gov/cber

CBER guidance and guidelines
www.fda.gov/cber/guidelines.htm

Investigational new drug (IND) details and guidance documents
www.fda.gov/cder/regulatory/applications/ind_page_1.htm

Medical Devices

Device advice
www.fda.gov/cdrh

Information on exempt devices at the Centre for Device & Radiologic Health (CDRH)
www.fda.gov/cdrh/devadvice/3133.html

List of exempt devices
www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpcd/315.cfm

Classifying a device
www.fda.gov/cdrh/devadvice/313.html

Device classification database
www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpcd/classification.cfm

510K guidance (“substantial equivalence”)
www.fda.gov/cdrh/devadvice/314.html

PMA guidance
www.fda.gov/cdrh/devadvice/pma/

Combination Products

Office of Combination Products (OCP)
www.fda.gov/oc/combination/

Assays & In Vitro Diadnostics (IVD)

In vitro diagnostics (OIVD/CDRH)

List of approved classified IVDs
www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfcfr/showCFR.cfm

Assignment of CLIA categories
www.fda.gov/cdrh/clia/

Life Science Software

Software guidance document for validation
http://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/GuidanceDocuments/ucm085281.htm

Guidance on Smartphone applications in a healthcare setting
www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/GuidanceDocuments/ucm263280.htm

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
www.access.gpo.gov/nara/cfr/waisidx_00/21cfrv8_00.html

Search of all databases
www.fda.gov/search/databases.html

Food and Drug Cosmetic Act (US)
www.fda.gov/opacom/laws/fdcact/fdctoc.htm

International Clinical Harmonization (ICH) – caution this is not US specific
www.ich.org

Device recalls
www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfTopic/medicaldevicesafety/recalls.cfm