New Guide Teaches Consumers How to Verify FDA Approved Medical Products
MedTruth recently reported a pandemic-related increase in fake “FDA Registration Certificates” being 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 approved or cleared medical products approved through the DeNovo process. (see below)
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, Clearance and Authorization Mean?
- FDA Approval means that the FDA has determined that the benefits of a medical product outweigh the risks, based on a review of scientific data submitted to provide evidence of safety and efficacy. “Approved” medical products come through one of two pathways: the DeNovo Classification Request or Premarket Approval (PMA). The DeNovo pathway can be used for low-to-moderate risk medical products, while the PMA pathway applies to high-risk medical products.
- FDA Clearance means that a new medical product is cleared because it’s “substantially similar” to medical products already approved through the DeNovo pathway. This process, known as 510(k), is more relaxed because it does not involve a direct assessment of the safety and efficacy of the new product.
- FDA Authorization refers to emergency use authorizations described above.
By MedTruth Editors