The BLOOD Centers Act directs the FDA to create a faster approval process for blood centers that want to add apheresis collection devices (equipment used to collect specific blood components) at new locations. Under this expedited process, the FDA must approve applications within 30 days of submission, unless the agency identifies specific safety concerns at that location or a pattern of regulatory failures by the blood center operator. The expedited approval applies only to blood center operators that already hold FDA licenses at multiple locations and have a strong compliance record, either through FDA approval at three or more registered sites or through accreditation by an organization meeting federal standards. This legislation aims to reduce delays in expanding blood collection capacity while maintaining safety standards. The FDA must establish this new expedited process within 180 days of the bill's enactment.
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