🏥FDA Guidance on Donor Eligibility for Human Products Available
Recommendations for Determining Eligibility of Donors of Human Cells, Tissues, and Cellular and Tissue-Based Products; Draft Guidance for Industry; Availability
Summary
The Food and Drug Administration (FDA or Agency) is announcing the availability of a draft guidance document entitled "Recommendations for Determining Eligibility of Donors of Human Cells, Tissues, and Cellular and Tissue-Based Products (HCT/Ps)." This draft guidance document includes general information on determining eligibility for donors of HCT/Ps. In addition, FDA intends to issue separate guidance documents with recommendations regarding reducing the risk of transmission of specific communicable disease agents and diseases for donors of HCT/Ps. These guidance documents are intended to update an existing guidance.
Agencies
- Health and Human Services Department
- Food and Drug Administration
Business Impact
$$ - Med
This draft guidance impacts businesses involved in human cells, tissues, and cellular products by updating compliance requirements for donor eligibility assessments, which could affect operations and regulatory adherence. This is critical for maintaining legal standards and minimizing health risks related to communicable disease transmission.