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FDA is the abbreviation of Food and Drug Administration (Food and Drug Administration). Authorized by the U.S. Congress, the federal government, the FDA is the highest law enforcement agency specializing in food and drug management. National health monitoring agency for government health control.
Food and Drug Administration (FDA) Supervisor: Supervision and inspection of food, drugs (including veterinary drugs), medical devices, food additives, cosmetics, animal food and drugs, wine and beverages with an alcohol content of less than 7%, and electronic products; products in use Or the ionizing and non-ionizing radiation generated in the process of consumption affects the testing, inspection and certification of human health and safety items. According to the regulations, the above-mentioned products must be tested and proved safe by the FDA before they can be sold on the market. FDA has the right to inspect manufacturers and prosecute violators.
FDA certification of medical devices, including: manufacturer registration with FDA, product FDA registration, product listing registration (510 form registration), product listing review and approval (PMA review), labeling and technical transformation of health care devices, customs clearance, registration, pre-marketing For the report, the following materials must be submitted:
(1) Five complete finished products are packaged,
(2) The structure diagram of the device and its text description,
(3) The performance and working principle of the device;
(4) Safety demonstration or test materials of the device,
(5) Introduction to the manufacturing process,
(6) Summary of clinical trials,
(7) Product instructions. If the device has radioactive energy or releases radioactive substances, it must be described in detail.
According to the different risk levels, FDA classifies medical devices into three categories (I, II, III), with category III having the highest risk level. FDA clearly defines its product classification and management requirements for each medical device. If any medical device wants to enter the U.S. market, it must first clarify the product classification and management requirements for listing.
The vast majority of products can be approved by the FDA after enterprise registration, product listing and implementation of GMP, or after submitting a 510(K) application.