Introduction to FDA

Frank Eng

IEEE-LEOS February 2006

U.S. Dept. of Health & Human Services 12+ Bureaucracies

Administration for Children and Families (ACF) Administration on Aging (AoA) Agency for Healthcare Research and Quality (AHRQ) Agency for Toxic Substances and Disease Registry (ATSDR)

Centers for Disease Control and Prevention (CDC) Centers for Medicare & Medicaid Services (CMS) Food and Drug Administration (FDA)
Health Resources and Services Administration (HRSA) Indian Health Service (IHS)

National Institutes of Health (NIH)

Program Support Center (PSC)

Substance Abuse and Mental Health Services Administration (SAMHSA)

CDC's Mission: To promote health and quality of life by preventing and controlling disease, injury, and disability. National Center on Birth Defects and Developmental Disabilities National Center for Chronic Disease Prevention and Health Promotion National Center for Environmental Health National Center for Health Statistics. National Center for HIV, STD, and TB Prevention National Center for Infectious Diseases National Center for Injury Prevention and Control National Immunization Program National Institute for Occupational Safety and Health Epidemiology Program Office Public Health Practice Program Office

Mission: Steward of medical and behavioral research for the Nation

National Cancer Institute National Eye Institute National Heart, Lung, and Blood Institute National Human Genome Research Institute National Institute on Aging National Institute on Alcohol Abuse&Alcoholism National Institute of Allergy&Infectious Diseases National Institute of Arthritis & Musculoskeletal and Skin Diseases National Institute of Biomedical Imaging and Bioengineering National Institute of Child Health & Human Development National Institute on Deafness and Other Communication Disorders National Institute of Dental & Craniofacial Research National Institute of Diabetes and Digestive and Kidney Diseases National Institute on Drug Abuse National Institute of Environmental Health Sciences National Institute of General Medical Sciences National Institute of Mental Health National Institute of Neurological Disorders & Stroke Library of Medicine Center for Information Technology Center for Scientific Review John E. Fogarty International Center National Center for Complementary and Alternative Medicine National Center on Minority Health and Health Disparities National Center for Research Resources NIH Clinical Center

FDA is a Regulatory Agency

FDA regulates products, not practices!

Food, Drug & Cosmetic Act Also the RCHSA and the BT Act, etc Regs: Title 21CFR, parts 1 to 1299 9,000 Employees (about 1,000 are in ORA field offices around the country)

FDA Organizational Units are:

CFSAN - Foods & Cosmetics, CFR 100 CDER Drugs, CFR 200 CVM - Vet Med & Vet Devices, CFR 500 CBER - Blood & Biologics, CFR 600 CDRH - Devices & Rad Health, CFR 800 ORA Inspectional Arm of FDA

Pre-Approvals
Not Required for: Food & Cosmetic products (exceptions: food & color additives) Required for: Drugs, Devices, Blood, Biologics, & Vet Med products but with exceptions as indicated in the CFR (i.e.: tongue depressors)

Center for Food Safety & Applied Nutrition

Food safety
BT Act Seafood HACCP Pesticide residues Imports

Approval and safety of food additives Cosmetic safety Labeling foods, cosmetics and dietary supplements

What CFSAN does NOT regulate

Restaurants & Grocery Stores (local HDs)

Meat, Poultry, Eggs (USDA)

(FDA is responsible for game meats and products containing <3% raw meat or <2% cooked meat)

Advertising for dietary supplements, food, cosmetics (FTC) Alcohol (TTB, Alcohol & Tobacco Tax & Trade Bureau) Water (EPA) (FDA is responsible for bottled water)

Center for Drug Evaluation and Research

RX, Generic, OTC Drugs:
- NDAs and ANDAs

Drug Clinical Investigations:

- INDs

Good Manufacturing Practices Adverse event reporting RX Drug Advertising

What CDER does NOT regulate

Illicit drugs (DEA) Triplicates (DEA) OTC drug advertising (FTC) Methadone treatment (SAMHSA)

Center for Veterinary Medicine

What CVM does NOT regulate:

Animal Vaccines (USDA) Meat products (USDA)

CBER Center for Biologics

Blood

supply Vaccines for human use Human tissue Allergenic materials and anti-toxins

What CBER does NOT regulate

Organs (HRSA) Drugs (CDER)

Center for Devices & Radiological Health

CDRH Medical Devices

Market via: PMAs or 510(k)s Clinical Investigations, IDEs required for significant risk devices Quality System Regulations (GMPs), 21CFR 820 Adverse Event Reporting SystemMDR/Medwatch Reports

RadHealth part of CDRH

Electronic Radiation Emitting Products (Medical & Non-Medical), 21CFR 1000 Non-Medical Products such as: TVs (CRT version), microwave ovens, tanning beds, laser products, mammography & x-ray products.

What CDRH does NOT regulate

Plastic gloves (CPSC) Toaster ovens (CPSC) Advertising for tanning booths (FTC) Nuclear materials in hospitals (NRC)

FDAs Rad Health Website www.fda.gov/CDRH/comp_ nonion_products.html

FDA Inspections - ORA

Drug & Device Inspections

Routine Pre-Approval Post-Approval For Cause

Medical Device Inspections

Quality System Requirements, 21CFR 820 (similar to ISO 9001) Management Controls Design Controls CAPA- corrective & preventive actions Production & Process Controls

Medical Fields #1
Clinical Chemistry Hematology/Pathology Immunology/Microbiology Anesthesiology Cardiovascular Dental Ear, Nose & Throat

Medical Fields #2
Gastroenterology-Urology General & Plastic Surgery General Hospital Neurological Ophthalmic Orthopedic/Physical Medicine Radiology etc

Technologies Encountered
Electronics, Software & Hardware Rubber, Plastics & Metal Purification: air, water, etc. Bio-Engineering: mono/polyclonal antibodies, etc. Sterilization: gas, steam, heat & radiation, plasma

Medical Device Inspections Primary Problem Areas

Management Controls Design Control Validation Issues Corrective & Preventative Actions

Laser Inspections
Purpose: To determine a manufacturers conformance with the Laser Product Performance Standard (safety features and labeling requirements)

Laser Inspections Items Covered

Organization Chart Product & Annual Reports Marketing Brochures Users Manuals, and or Service Manuals Quality Control Procedures Manufacturing Records Equipment Calibration Records

Laser Inspections Primary Problem Areas

Lack of documentation to show conformance with the LPPS Lack of Product/Annual Reports Inadequate labeling. Lack of required safety features. Failure to report corrective actions.

Laser Inspections Primary Advice Given

Laser Notice 50 Within certain requirements, manufacturers are allowed to use yellow & black *European style labels, in lieu of the traditional red/black/white American style labels. * IEC 60825-1 & IEC 60601-2-22

Regional Small Business Representative

Marsha Madrigal (510) 637-3980 Helps small businesses whose products are regulated by FDA Provides information that clarifies how agency laws and regulations apply to their business Suggest methods to meet requirements Respond to inquiries, conduct or participate in workshops and conferences, or visit your plant, at your request, to offer assistance

Consumer Complaints
Charla Tate @ (510) 337- 6741
Foods Drugs Devices Blood CVM

What complaints are not FDAs

Problem with restaurant food (HD) Problem with physician (MB) Problem with pharmacy (BoP)

What about the State?

DHS - Food and Drug Branch (916) 650-6500 http://www.dhs.ca.gov/fdb/ Food and Agriculture (800) 675-2427 http://www.cdfa.ca.gov/ Department of Consumer Affairs (800) 952-5210 http://www.dca.ca.gov/ Board of Pharmacy (916) 445-5014 http://www.pharmacy.ca.gov/ Medical Board (800) 633-2322 http://www.medbd.ca.gov/ Others: Cal EPA, EHIB

Food Stamp, School Lunch, School Breakfast, and the WIC Programs Oversees 192 million acres of national forests and rangelands Conservation to protect soil, water, wildlife on the 70 % private lands Housing, telecommunications, and safe drinking water to rural America USDA is responsible for the safety of meat, poultry, and egg products USDA is a research leader in everything from human nutrition to new crop technologies USDA helps ensure open markets for U.S. agricultural products and provides food aid to needy people overseas.

USDA Agencies
Agricultural Research Service Animal and Plant Health Inspection Service Center for Nutrition Policy and Promotion Cooperative State Research, Education and Extension Service Economic Research Service Farm Service Agency Food and Nutrition Service Food Safety & Inspection Service Foreign Agricultural Service Forest Service Grain Inspection, Packers and Stockyards Administration National Agricultural Library National Agricultural Statistics Service Natural Resources Conservation Service Risk Management Agency Rural Development

Vigilance, Service, Integrity

Imports
Duties International agreements BT Commercial enforcement Regulatory audits Commercial enforcement Carriers

Department of Commerce

BUREAU OF CONSUMER PROTECTION

Division of Advertising Practices Division of Enforcement Division of Financial Practices Division of Marketing Practices Division of Planning and Information Consumer and Business Education Program International Division of Consumer Protection

BUREAU OF COMPETITION
Mergers and Anti-trust laws

BUREAU OF ECONOMICS

Department of Justice

Investigation/prosecution of controlled substance laws Investigation/prosecution of criminals and drug gangs who perpetrate violence in our communities and terrorize citizens through fear and intimidation. National drug intelligence program with federal, state, local, and foreign officials on drug intelligence information. Seizure and forfeiture of assets derived from illicit drug trafficking. Enforcement of the provisions of the Controlled Substances Act as they pertain to the manufacture, distribution, and dispensing of legally produced controlled substances. Coordination/cooperation with federal, state and local law enforcement on mutual drug enforcement efforts and reduction of abuse-type drugs on market through nonenforcement methods i.e. crop eradication or substitution Liaison with the United Nations, Interpol, and other organizations on matters relating to international drug control programs.

Federal agency?
Federal Information Center (800) 688-9889