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U.S. Department of Health and Human Services

For Industry

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I work in a hospital transfusion service - do we need to register with FDA?

Some transfusion services are exempt from FDA registration. Transfusion services that are part of a facility that is certified under the Clinical Laboratory Improvement Amendments, or that has met equivalent requirements as determined by the Center for Medicare and Medicaid Services, and which are engaged in compatibility testing and transfusion of blood and blood components, but which neither routinely collect nor process these products, are not required to register with FDA. Information regarding exemptions for transfusion service registrations is found in FDA regulations in 21 CFR 607.65(f).

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