Why are FDA “certificates” so important for medical devices?
If you want to sell Class II medical devices such as non-contact thermometers in 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 FDA and receive FDA clearance prior to marketing these devices in the United States, as well as comply with post-marketing requirements.So FDA don’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 USA.
How to distinguish the authenticity of the FDA Authorization ?
1. Require the manufacturers or distributors to provide 510(k) number
2. Log in FDA’s website: www.fda.gov. Click “menu”–medical devices and find the following page.
3. Enter 510(k) number, you will find the detailed information of the product.
