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Which products exported to the United States need FDA certification?

Date:2023-02-03 10:14:51 Classification :【question】 Visits:

The United States Food and Drug Administration (hereinafter referred to as the "FDA"), which is the full English name of the United States Food and Drug Administration, is subordinate to the United States Department of Health and Human Services, and is responsible for the supervision of food, drugs, biological products, medical devices, tobacco products, cosmetics and veterinary drugs.


FDA has a tremendous influence in the United States and even the world, and is known as the "guardian of American health". Its credibility and professional level have won the trust of many experts and the general public. To this day, FDA has become the diamond shield in the hearts of global food and drug consumers.


FDA Registration

In order to ensure that manufacturers' products are exported to the United States in compliance with local FDA requirements, enterprises are required to carry out the self-declaration guarantee process. In fact, most of the FDA registrations in the United States have not been tested by a third party, but are self-guaranteed by enterprises.


FDA testing

FDA testing refers more to the safety testing of food contact materials, biological compatibility testing of medical products, and clinical safety testing.


FDA evaluation

Taking cosmetics as an example, the main purpose is to evaluate the outer packaging and ingredient description.

Scope of products covered by FDA:

1、 Food: all food exported to the United States (including health food, drinking water, food additives, infant food, etc.);

2、 Drugs: drug raw and auxiliary materials, drug packaging materials, human vaccines, prescription drugs, over-the-counter drugs, etc;

3、 Cosmetics: skin care products, makeup, shampoo, etc;

4、 Medical instruments: ventilator, endoscope, wheelchair, electronic thermometer, sphygmomanometer, mask, protective clothing, etc;

5、 Laser radiation products: microwave oven, CT, X-ray equipment, etc;

6、 Food contact materials: parts and raw materials of food contact materials (various plastics, metals, ceramics, glass, bamboo and wood products, etc.);

7、 Veterinary products: livestock feed, pet food, veterinary medicine, etc.


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