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Overview | The FDA (Food and Drug Admistraton referred to as FDA), the U.S. Food and Drug Administration, is affiliated with the U.S. Department of Health Education and Welfare. Some people say that it is equivalent to the Chinese State Drug Administration, which is in fact inaccurate. Accurately speaking, the US FDA is the equivalent of China's Ministry of Health (responsible for the approval of health food) and the State Drug Administration (responsible for the approval of drugs) two industry management agencies. It is responsible for the management of pharmaceuticals, foods, biological products, cosmetics, veterinary drugs, medical devices, and diagnostic products throughout the United States and is committed to protecting, promoting and improving the health of the people and ensuring that food, medicines, cosmetics and medical devices sold on the U.S. market are The safety and effectiveness of the human body. Under the FDA, the Drug Administration, the Food Bureau, the Bureau of Veterinary Drugs, the Bureau of Radiation Health, the Bureau of Biological Products, the Institute of Medical Devices and Diagnostic Products, the National Institute of Toxicology, and the regional work management agency, ie, 6 bureaus (some publications are also called 6 Center), a center and a regional management agency. |
Range | medical products - X-ray diagnostic medical products (general use, fluorescent X-ray, CT, etc.) - Surgical and other laser devices and devices with laser units - Special-purpose laser products (including display, observation and medical) - Ultraviolet treatment equipment (medical UV lamps and products) - Other medical ultrasound equipment not for physical therapy and diagnosis - Microwave diathermy and microwave blood heaters - Ultrasound physiotherapy equipment Electronic products with ionizing radiation - TV and video display in CRT display mode Non-ionizing radiation electronic products - Microwave oven - sunlamps and sun light products (sun beds) - Cellular mobile phones - X-ray device with protective housing (eg X-ray inspection system, X-ray imaging system, X-ray security inspection system, X-ray baggage inspection system) Industrial and scientific products - laser tools and laser instruments - Non-medical diagnostic X-ray equipment - RF and Microwave Products (non-microwave) - Non-diagnostic and therapeutic ultrasound products FDA implements two types of management of food, medicine, and equipment, namely: Approved and notification Medical product management classification Class I - danger to the user of such products is not generated, the design is generally simpler than grade II and III, as enemas. 47% of medical products belong to this level, 95% of which do not require regulatory management. Level II - Most medical products belong to level II, and products belonging to level II account for 43%, such as electric wheelchairs, maternity supplies. |
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