MedTruth recently reported a pandemic-related increase in fake “FDA Registration Certificates” used to fraudulently promote medical products. As part of the Food and Drug Administration response to the growing problem, the agency published an online consumer guide entitled “Are There ‘FDA Registered’ or ‘FDA Certified’ Medical Devices? How Do I Know What Is FDA Approved?”
To set the record straight for consumers:
While companies that manufacture and distribute medical products in the U.S. are generally required to register with the FDA, the agency does not issue registration certificates. (“Medical device” is the term typically used by the FDA and which includes everything from bedpans, tongue depressors, electric toothbrushes and wheelchairs to pacemakers, stents and artificial joints.)
What Do Consumers Need to Know?
- The FDA does not issue registration certificates.
- All “FDA registration certificates” for medical products are fake.
- Fake “FDA registration certificates” often look official and many display the FDA logo in order to deceive consumers.
- Use of these fake certificates to market products is a violation of federal law.
How Do I Verify FDA Approved, Cleared or Authorized Medical Products?
Consumers who want to know if a medical product is FDA approved, cleared or authorized should check all three of the following FDA webpages:
Lists medical products approved or cleared through the Premarket Approval and 510(k) processes. (see below)
Lists all medical products authorized for market through the DeNovo process. (see below)
Emergency Use Authorizations Page
Lists medical products authorized for use in situations of national emergency in order “to diagnose, treat, or prevent serious or life-threatening diseases or conditions.” Includes unapproved medical products authorized for first-time use and previously approved products authorized for new uses. Emergency use authorizations (EUAs) are used only when certain criteria are met, such as when there are no adequate, approved, or available alternatives.
What Does FDA Approval, Authorization and Clearance Mean?
FDA Approval refers to high-risk medical products that come through the Premarket Approval (PMA) pathway, the most stringent type of FDA medical product review.
FDA Authorization can refer to medical products authorized for sale when a DeNovo Classification Request is granted (see below), or it can refer to Emergency Use Authorization.
The DeNovo process is used for low-to-moderate risk medical products. DeNovo establishes a new device classification upon which "clearance" for other new products can be based.
Both Premarket Approval and DeNovo authorization are based on FDA review of scientific data that's been submitted to demonstrate the safety and efficacy of the specific new products.
FDA Clearance refers to a new medical product that is “substantially similar” to products already authorized through DeNovo classification. This process, known as 510(k), is more relaxed than DeNovo or Premarket Approval because it does not require submission of scientific data for the new product.