Purpose and scope.

(a) What is the purpose of subparts A, B, and C of this part ? The purpose of these subparts, together with §§ 610.40 and 610.41 of this chapter, is to provide certain minimum criteria for each donation of blood and blood components, for: (1) Determining the eligibility of a donor of blood and blood components; (2) Determining the suitability of the donation of blood and blood components; and (3) Notifying a donor who is deferred from donation. (b) Who must comply with subparts A, B, and C of this part ? Blood establishments that manufacture blood and blood components, as defined in § 630.3(a) and (b), must comply with subparts A, B, and C of this part.