FDA Terminology: Device Registration, Clearance, or Approval?

FDA terminology is exacting when describing medical device Registration, Clearance, and Approval.   It would be inappropriate for a manufacturer to claim FDA "endorsement" for registering their company and its products.  

Here are definitions of terms:

Registration: 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.”

Clearance: 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.

Approval: 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.

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