Biologics products; establishment registration and product listing for manufacturers of human blood and blood products; amendment to exempt certain transfusion services from registration--FDA. Final rule.
The Food and Drug Administration (FDA) is amending the biologics regulations to exempt from FDA's requirements for establishment registration and product listing (and routine establishment inspection) certain transfusion services that routinely prepare red blood cells and that are approved for Medicare reimbursement by the Health Care Financing Administration (HCFA). FDA is amending the regulations as a followup to a revision of a Memorandum of Understanding (MOU) between the Public Health Service (PHS), FDA, and HCFA. Under this revision of the MOU, FDA will not perform routine inspections of transfusion services that routinely prepare red blood cells, to avoid duplicative regulatory inspections of such facilities by both HCFA and FDA. The amended MOU is published with this final rule as Appendix A.
D001771:Blood Banks / Q000592:standards*; D001803:Blood Transfusion / Q000592:standards*; D014487:Centers for Medicare and Medicaid Services, U.S.; D006801:Humans; D006278:Medicare; D014481:United States; D014486:United States Food and Drug Administration