Below is a guide to FDA-Regulated products for start-ups and others who produce or process a product which is at the mercy of rules by the FDA. FOOD, including dietary supplements, water in bottles, food additives, baby formulas (meats, poultry and egg products are governed by the USDA). Products that are consumed by humans, including nicotine gum, drinks and dietary supplements are believed foods.
Facilities which manufacture or process food products must enroll with the FDA. DRUGS, including prescription and non-prescription (OTC) drugs. BIOLOGICS, including vaccines, blood and blood products, mobile and gene therapy products, cells and tissues products and allergenics. MEDICAL DEVICES, including both simple items (tongue depressors) and complex technologies (pacemakers), dental devices and surgical implants and prosthetics.
ELECTRONIC PRODUCTS THAT EMIT RADIATION, including microwave ovens, x-ray equipment, laser beam products, ultrasonic therapy equipment, mercury vapor sunlamps and lights. Products which emit radiation of any sort may be regulated by the FDA. COSMETICS, including color additives found in makeup and other personal care products, skin moisturizers and cleaners, nail polish and perfume.
VETERINARY PRODUCTS, including livestock feeds, pet foods and veterinary drugs and devices. Product or Products ideas that are a drug, device, or food given to, or used on an animal are considered Veterinary Products. TOBACCO PRODUCTS, including cigarettes, tobacco and smokeless tobacco. Products which are produced from or produced from tobacco are believed tobacco products.
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