Exemption of certain transfusion services and clinical laboratories from registration: Food and Drug Administration. Final rule.
The Food and Drug Administration (FDA) is amending the biologics regulations to exempt transfusion services and clinical laboratories that are approved for Medicare reimbursement from FDA's registration and product listing requirements. This rule implements a Memorandum of Understanding concluded between the Public Health Service (PHS), including FDA, and the Health Care Financing Administration (HCFA). To avoid unnecessary regulatory duplication, FDA has agreed not to conduct routine inspections of these exempted facilities.
D001771:Blood Banks / Q000592:standards*; D001803:Blood Transfusion / Q000592:standards*; D006761:Hospitals; D006801:Humans; D007753:Laboratories / Q000592:standards*; D006278:Medicare / Q000331:legislation & jurisprudence; D014481:United States; D014486:United States Food and Drug Administration