How to check whether a company has passed FDA certification

FDA certification is divided into many product categories, different types of query methods are very different.

Such as medical devices can be searched for directly on the FDA website; food products require companies to provide a user name and password to query; radiation (laser, ionizing electromagnetic, microwave, x-ray, mercury vapor lamps, etc.) is simply not in the FDA website query, you can only e-mail, mail, or call the FDA for verification.

Expanded Information:

Medical Devices. p>The FDA has a clear and strict definition of a medical device, which is defined as follows: "Medical device means an instrument, apparatus, tool, machine, appliance, insertion tube, in vitro reagent, and other related articles, including components, parts, or accessories, that are expressly listed in the National Formulary or the Unite States Pharmacopeia or the Appendix to the foregoing; intended for use in the diagnosis of disease or other physical conditions in animals or humans, or in the cure, mitigation, and treatment of disease; and intended to affect the function or structure of the body of an animal or a human being other than through metabolism for its primary purpose.".

Only products that meet the above definition are considered medical devices. Under this definition, not only are all kinds of instruments and tools used in hospitals, but even eyeglass frames, eyeglass lenses, toothbrushes, and fitness equipment such as massagers, etc., which can be purchased by consumers in general stores, fall within the scope of the FDA's management. It is slightly different from the domestic recognition of medical devices.

Based on the different levels of risk, the FDA classifies medical devices into three categories (I, II, and III), with Class III having the highest level of risk.

The FDA clearly defines the product classification and management requirements for each type of medical device, and the FDA's medical device product catalog has included more than 1,700 types of products. Any medical device that wants to enter the U.S. market must first be clear about the product classification and regulatory requirements.

References:

Baidu Wikipedia - FDA approval