The United States Food and Drug Administration (FDA) is responsible for ensuring the safety of domestically produced or imported food, cosmetics,

medical devices and laser radiation products in the United States.

FDA services mainly consist of two parts: testing and registration:

• The first type is FDA testing, which means testing products in accordance with relevant FDA regulations and issuing test reports. This is commonly applied to testing of food-contact

• materials;

• The other type is FDA registration, mainly covering food (all food for human and animal consumption), drugs, medical devices, cosmetics,

• laser products, etc.

FDA regulates medical devices through the Center for Devices and Radiological Health (CDRH). The center supervises manufacturers, packagers and distributors of medical devices to ensure

their business activities comply with relevant laws.

Medical devices cover a wide range, from small items such as medical gloves to large equipment like cardiac pacemakers, all under FDA oversight. Based on intended medical use and potential risks to human bodies,

FDA classifies medical devices into Class I, Class II and Class III. Higher classes face stricter supervision. For innovative products that have never been available on the market, FDA requires manufacturers

to conduct rigorous human trials and provide convincing medical and statistical evidence to verify the effectiveness and safety of the product.

FDA certification for medical devices includes: manufacturer registration with FDA, device listing with FDA, pre-market notification (510(k) submission), pre-market approval (PMA review), labeling and technical modification of healthcare devices, customs clearance, registration, pre-market reports. The following materials must be submitted:

(1) Five complete finished packaged products;

(2) Structural drawings and written descriptions of the device;

(3) Performance and working principle of the device;

(4) Safety demonstration or test data of the device;

(5) Brief introduction to manufacturing process;

(6) Summary of clinical trials;

(7) Product manual. If the device emits radiation or radioactive substances, detailed description is required.