Alternative Procedures for the Manufacture of Cold-Stored Platelets Intended for the Treatment of Active Bleeding when Conventional Platelets Are Not Available or Their Use Is Not Practical: Guidance for Industry

Issue Date: June 23, 2023
Issued by: Center for Biologics Evaluation and Research
Topic(s): Blood, Blood Products
Status: Final

Alternative Procedures for the Manufacture of Cold-Stored Platelets Intended for the Treatment of Active Bleeding when Conventional Platelets Are Not Available or Their Use Is Not Practical: Guidance for Industry

FDA (we) is issuing this guidance to provide a notice of exceptions and alternatives to certain requirements in Title 21 of the Code of Federal Regulations (CFR) regarding blood and blood components. This notice is being issued under 21 CFR 640.120(b) to respond to a public health need and address the urgent and immediate need for platelets for the treatment of active bleeding when conventional platelets are not available, or their use is not practical. Maintaining platelet availability in the face of logistical challenges (e.g., in military, prehospital, or austere settings) or other threats to blood availability (e.g., mass casualty events or public health emergencies) is critical to assure that platelets are available to patients with active bleeding.

Download the Guidance Document