The Food and Drug Administration of the United States, abbreviated as FDA, is responsible for ensuring the safety of food, cosmetics, medical devices and laser radiation products manufactured domestically or imported into the United States.

FDA services mainly fall into two categories: testing and registration:

• The first category is FDA testing, which means testing products in accordance with relevant FDA regulatory requirements and issuing test reports. This is commonly required for materials that come into contact with food;

• The other category is FDA registration, primarily covering food (all food for human and animal consumption), pharmaceuticals, medical devices, cosmetics, laser products and so on.

The FDA regulates medical devices through the Center for Devices and Radiological Health (CDRH). This center oversees manufacturers, packagers and distributors of medical devices to ensure they conduct business activities in compliance with relevant laws.

Medical devices cover a wide range of items, from small medical gloves to large cardiac pacemakers, all subject to FDA supervision. Based on their medical application and potential risks to human health, the FDA classifies medical devices into Class I, Class II and Class III, with stricter supervision imposed on higher classes. For innovative products that have never been available on the market, the FDA requires manufacturers to conduct rigorous human trials and provide convincing medical and statistical evidence to prove the product’s efficacy and safety.

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

(1) Five fully packaged finished products;

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

(3) Product performance and working principles of the device;

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

(5) Brief introduction to manufacturing processes;

(6) Summary of clinical trials;

(7) Product user manual. If the device emits radiation or radioactive substances, detailed descriptions must be provided.