21 CFR 640.20 - Platelets.
(a)Proper name and definition. The proper name of this product shall be Platelets. The product is defined as platelets collected from one unit of blood and resuspended in an appropriate volume of original plasma, as prescribed in § 640.24(d).
(b)Source. The source material for Platelets is plasma which may be obtained by whole blood collection or by plateletpheresis.