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FDA Registration

I’m posting this message at the request of a colleague. “George, I’m told by one of my suppliers that their products are US FDA registered. Does this mean the FDA endorses the company and its products?”

Thank you for your question. FDA terminology may sometimes be complex and has perhaps confused your supplier’s representative. The FDA uses three terms, cleared, approved, and registered.

FDA clearance is an indication that a medical device is substantially equivalent to an existing device for a particular purpose. FDA clearance is achieved through the “510(k)” application process and is used primarily for medical devices. In vitro diagnostic assays are classified as medical devices by the FDA.

FDA approval is granted typically for new drugs or devices and assures that the new device is reasonably safe and effective. Approval is granted as a result of a premarket approval (PMA) application. Occasionally, in vitro diagnostics companies apply through the PMA process, though we usually use the 510(k) approach.

Manufacturers and distributors of drugs and devices marketed in the United States must register with the FDA, list their products, and pay a fee. The FDA states, “Registration of a device establishment, assignment of a registration number, or listing of a medical device does not in any way denote approval of the establishment or its products by FDA.”

Based on these criteria, it would be inappropriate for a manufacturer to claim FDA “endorsement” for registering their company and its products.

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