The FDA defines medical devices as instruments, devices, tools, machinery, instruments, insertion tubes, in vitro reagents and other related items, including components, parts or accessories, which are clearly listed in the national formulary of the United States or the appendix of the United States Pharmacopoeia or both; It is expected to be used to diagnose diseases or other physical conditions of animals or humans, or to cure, alleviate and treat diseases; It is expected to affect the body function or structure of animals or humans, but it is not through metabolism to achieve the main purpose.

According to medical use and possible harm to human body, FDA classifies medical devices into Class I, Class II and Class III. The higher the category, the more supervision.

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