REGULATORY UPDATE: New FDA Guidance Focuses on Manufacturing Blood Components Using the Buffy Coat Method

The Food and Drug Administration released a draft guidance Oct. 17, offering recommendations to manufacturers seeking FDA approval or clearance to market blood collection, processing and storage systems designed to manufacture blood components for transfusion using the buffy coat (BC) method. Currently, U.S. blood establishments prepare whole blood (WB)-derived blood components using the platelet-rich plasma (PRP) method.

In the guidance, FDA cites studies demonstrating that blood components prepared using the BC method are biochemically and physiologically comparable to those prepared using the PRP method.

“In addition, use of the BC method may offer logistical advantages, which could result in higher plasma and platelet recovery and increased platelet availability, when compared to the PRP method,” the agency said.

Notably, the recommendations in the guidance do not apply to devices used to manufacture PRP or similar products used for therapeutic purposes other than transfusion.

FDA is accepting comments on the proposed guidance through Dec. 17. Submission instructions are available in the Federal Register notice.