§ 640.10 Red Blood Cells

The proper name of this product shall be Red Blood Cells. The product is defined as red blood cells remaining after separating plasma from human blood.

Independent copy, not an official legal edition. 21 CFR is a U.S. Government work in the public domain; this text comes from the eCFR and the annual CFR edition, and may lag recent amendments. The authoritative version is on ecfr.gov. Compliome is not affiliated with or endorsed by FDA. Not legal advice.

FDA guidance that cites § 640.10

• Recommendations for Screening, Testing, and Management of Blood Donors and Blood and Blood Components Based on Screening Tests for Syphilis: Guidance for Industry 2 Dec 2020

Amendment history

Federal Register documents that created or amended this section.

• 38 FR 32089 20 Nov 1973
• 50 FR 4138 29 Jan 1985