As protective equipment to combat and remain safe from the coronavirus surges, there has been a rise in unauthorized medical equipment and products. The FDA has now revealed its actions against businesses that market devices by falsely claiming approval, certification, permission, or oversight from the agency.
Certain businesses may be using something called “FDA registration certificates”. The records seem to be official government documentation indicating that the FDA has taken a look at the product or item. While the FDA does have its Establishment Registration & Device Listing system it uses for registration purposes, the federal agency does not provide certificates to those businesses within that system.
The FDA contacted more than twenty companies that create and issue possibly deceptive certificates to medtechs after noticing an increase in their use during the pandemic. According to the letters, registration certificates are being used by some device manufacturers and distributors to give the false perception that their products have been checked, authorized, cleared, or sanctioned by the FDA.
The statement was released on the same day that the FDA launched a consumer-facing website to clarify how words like FDA Registered, FDA Certified, and FDA Registration Certificate may be used in a way to create possible public deception. The words do not imply that a product has been licensed, registered, or cleared by the department, according to the website.
For anyone who may be curious about the status of their device or product, the best way to go is to search the FDA database and see if the product has received emergency use authorization.
For any questions regarding FDA registration or if help is needed with the process, please visit the UReg – FDA Registrations website. We work with domestic and international clients across a broad spectrum of industries and product categories like food, cosmetics, dietary supplements, and so much more.