(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.