Revised Recommendations for Determining Eligibility of Donors of Human Cells, Tissues, and Cellular and Tissue-Based Products Who Have Received Human-Derived Clotting Factor Concentrates: Guidance for Industry

Description

This guidance provides you, establishments that make donor eligibility (DE) determinations for donors of human cells, tissues, and cellular and tissue-based products (HCT/Ps), with information on infectious-disease risks related to receipt of FDA licensed human-derived clotting factor concentrates (HDCFCs). This guidance explains that FDA no longer considers FDA licensed HDCFCs as a risk factor for Human immunodeficiency virus (HIV), Hepatitis B virus (HBV), or Hepatitis C virus (HCV). As such, receipt of FDA licensed HDCFCs, or sex with a person who has received FDA licensed HDCFCs, should not be considered a risk factor when determining eligibility of a donor of HCT/Ps. This guidance supplements the recommendations regarding HDCFCs that are contained in the guidance entitled “Eligibility Determination for Donors of Human Cells, Tissues, and Cellular and Tissue-Based Products (HCT/Ps); Guidance for Industry” dated August 2007 (August 2007 Guidance).

Scope & Applicability

• 21CFR1271.47§ 1271.47 What procedures must I establish and maintain?

  (a) General. You must establish and maintain procedures for all steps that you perform in testing, screening, determining donor eligibility, and complying with all other requirements of this subpart. Establish and maintain means define, document (in writing or electronically), and implement; then foRead full regulation →

• 21CFR1271.45§ 1271.45 What requirements does this subpart contain?

  (a) General. This subpart sets out requirements for determining donor eligibility, including donor screening and testing. The requirements contained in this subpart are a component of current good tissue practice (CGTP) requirements. Other CGTP requirements are set out in subpart D of this part .Read full regulation →

• 21CFR1271.75§ 1271.75 How do I screen a donor?

  (a) All donors. Except as provided under § 1271.90 , if you are the establishment that performs donor screening, you must screen a donor of cells or tissue by reviewing the donor's relevant medical records for:Read full regulation →

• 21CFR10.115§ 10.115 Good guidance practices.

  (a) What are good guidance practices? Good guidance practices (GGP's) are FDA's policies and procedures for developing, issuing, and using guidance documents.Read full regulation →

• Deviations/CFR/Regulations for Human Cells, Tissues & Cellular Products (HCT/Ps)

  New Mexico Lions Sight Conservation Foundation, Inc. dba New Mexico Lions Eye Bank

  2024-07-09

• Deviations/CFR/Regulations for Human Cells, Tissues & Cellular Products (HCT/Ps)

  Indiana Lions Eye Bank, Inc. dba VisionFirst Indiana Lions Eye Bank

  2024-06-25

• Deviations/CFR/Regulations for Human Cells, Tissues & Cellular Products (HCT/Ps)

  The New Hope Center for Reproductive Medicine

  2023-07-11

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