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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...