For example, medical devices can be directly searched and queried in FDA official website; Food requires the company to provide user name and password for inquiry; Radiation category (laser, ionizing electromagnetic, microwave, X-ray, mercury vapor lamp, etc. ) You can't check in official website of FDA at all, so you can only send an email, a letter or call the FDA for verification.
Extended data:
The FDA has a clear and strict definition of medical devices, and its definition is as follows: "The so-called medical devices refer to instruments, devices, tools, machinery, instruments, insertion tubes, in vitro reagents and other related articles, including parts, parts or accessories, which are clearly listed in the national formulary of the United States or the United States Pharmacopoeia or their appendices; 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 not through metabolism. "
Only products that meet the above definition can be regarded as medical devices. Under this definition, not only all kinds of instruments and tools in hospitals, but also fitness equipment such as glasses frames, glasses, toothbrushes and massagers that consumers can buy in general stores belong to the management scope of FDA. It is slightly different from the domestic medical device appraisal.
According to different risk levels, FDA classifies medical devices into three categories (I, II and III), and the third category has the highest risk level. The FDA clearly stipulates the product classification and management requirements of each medical device, and the FDA medical device product catalogue has included more than 700 products/kloc-0. Any kind of medical device that wants to enter the American market must first understand the classification and management requirements of the products applied for marketing.
References:
Baidu encyclopedia -FDA certification