§ 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.

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FDA guidance that cites § 640.20

• 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 23 Jun 2023
• Collection of Platelets by Automated Methods: Guidance for Industry and FDA Review Staff 1 Dec 2007

Amendment history

Federal Register documents that created or amended this section.

• 40 FR 4304 29 Jan 1975
• 47 FR 49021 29 Oct 1982
• 50 FR 4139 29 Jan 1985
• 72 FR 45887 16 Aug 2007