Why are FDA “certificates” so important for medical devices?

If you want to sell Class II medical devices such as non-contact thermometers in the USA, you must meet the requirements of the U.S. Food and Drug Administration (FDA). Manufacturers of clinical electronic thermometers are required to submit a premarket notification under section 510(k) of the FD&C Act to the FDA and receive FDA clearance before marketing these devices in the United States, as well as comply with post-marketing requirements. So FDA doesn’t issue so-called FDA certificates; instead, they provide a letter informing you that your 510(k) premarket notification of the medical device has been reviewed and the device is officially 510(k)-cleared and meets the related enactments, therefore, you can market the device in the USA.

How to distinguish the authenticity of the FDA  Authorization?

1. Require the manufacturers or distributors to provide a 510(k) number
2. Log in FDA’s website: www.fda.gov. Click “menu”-medical devices and find the following page.

    
3. Enter the 510(k) number, and you will find the detailed information about the product.