FDA is the abbreviation of U.S. Food Drug Administration, the Chinese translation of the name "U.S. Food and Drug Administration".
The products regulated by the FDA are mainly food, drugs, medical devices, microbial products, pet food and medicines, but also cosmetics, radioactive products, combination products and other electronic products related to personal health and safety and medical products.
The products regulated by the FDA are listed as follows:
Medical products
-X-ray diagnostic medical products (general purpose, fluorescent X-rays, CT, etc.)
- Surgical and other laser devices and devices with laser units
-Special purpose laser products (including display, observation and medical)
-Ultraviolet therapeutic equipment (medical ultraviolet lamps and products)
-Other medical ultrasound equipment for non-physical therapeutic and diagnostic purposes
- Microwave diathermy and microwave blood heaters
-Ultrasonic physiotherapy equipment
Electronic products with ionizing radiation
-Televisions and video monitors with CRT displays
Electronic products with non-ionizing radiation
-Microwave ovens
-Sunlamps and sunlamp products (sunbeds)
-Cellular cellular telephones
-Laser products: these include laser pointers, laser presentations, laser displays, products containing laser units (CD players, DVDs, CD-ROMs, laser printers, etc.
Safety protection and rescue products
-X-ray equipment with protective housings (e.g., X-ray inspection systems, X-ray imaging systems, X-ray security systems, X-ray baggage inspection systems)
Industrial and scientific research products<
-Laser tools and laser instruments
-Non-medical diagnostic X-ray equipment
-Radiofrequency and microwave products (not microwave ovens)
-Ultrasound products for non-diagnostic and therapeutic purposes
The FDA regulates food, drugs and devices in two categories: approved and notified
Medical Product Stewardship Classification
Class I - These products pose little risk to the user, and are usually designed to be simpler than Class II and III products, such as enemas. Class II and III, such as enemas. Forty-seven percent of all medical products fall into this class, and 95 percent of them do not require regulatory controls.
Class II - The majority of medical products fall into Class II, with 43% of products falling into Class II, such as motorized wheelchairs and maternity products.
Class III - Products in this class are typically used to maintain or support human life, and their use can be potentially harmful or injurious to a person. Examples include: implantable cardiac pacemakers, breast augmentation fillers, etc. Ten percent of medical products fall into Class III.
For Class I products, 95% of which are exempted from regulation as medical devices, there is no requirement to apply for a notification or a license (clearance) before placing the product on the market. However, manufacturers are required to register with the FDA and list their major products. Examples of such regulated products are artificial stethoscopes, mercury thermometers, and bidets.
Products not regulated by FDA
All advertising materials except those involving drugs and food
These advertising materials are regulated by the Federal Trade Commission (FTC). The FTC regulates advertising materials based on their truthfulness and whether they are misleading to consumers.
Alcohol and alcoholic beverages are regulated by the ATF for labeling and physical quality of alcohol and alcoholic beverages.
Consumer products are regulated by the U.S. Consumer Product Safety Commission (CPSC. Consumer Product Safety Committee) for the safety of consumer products, which are primarily household appliances (those that emit radiation are still regulated by the FDA), paints, potentially child-hazardous bags, and children's toys. Consumers can report unsafe consumer products in writing to the CPSC or request information about the product and market recalls.
Medicine Abuse
The illegal use of unapproved medicines is regulated by the Drug Enforcement Administration (DEA.) The FDA assists technically in making decisions about what strict controls to place on medicines that are therapeutic in their own right, but that may have abusive results.
Medicare
The FDA is not involved with Medicare, the cost of health care products or procedures, medical indemnification, and so on.
Meat and Poultry
The U.S. Department of Agriculture's Food Safety and Inspection Service is responsible for inspecting and regulating the quality and labeling of conventional meat and poultry products, while the FDA regulates meat from hunted wildlife, such as venison, ostrich, and snake.
Insecticides and Pesticides
The FDA, USDA, and the Environmental Protective Agency (EPA)**** regulate insecticides and pesticides.EPA determines the safety and efficacy of chemical ingredients, and establishes levels of permissible residues in cultivated crops, including wild and processed crops. levels in grown crops, but also in wild and processed crops. This value is usually set at 100 times less than the amount that could be harmful to humans and the environment.
The FDA and USDA are responsible for monitoring the food supply to ensure that pesticide residues do not exceed the permitted limits. Public questions about environmental protection can be e-mailed directly to the U.S EPA.
Restaurants and food establishments
Restaurant and food establishment inspections and licensing are largely the responsibility of local government health departments.
Water
Water quality is regulated by the Environmental Protection Office EPA and FDA, respectively.EPA is responsible for setting national standards for drinking water in municipal water supplies and water quality regulation, while FDA is responsible for labeling of barrels of water and water safety regulation.