Search Results for keywords:"donor eligibility"

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Search Results: keywords:"donor eligibility"

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  • 2024-31538 — Recommendations To Reduce the Risk of Transmission of Disease Agents Associated With Sepsis by Human Cells, Tissues, and Cellular and Tissue-Based Products; Guidance for Industry; Availability
    Type:Notice
    Citation:90 FR 1141
    Reading Time:about 7 minutes

    The Food and Drug Administration (FDA) has released new guidance aimed at reducing the risk of disease transmission caused by sepsis in human cell and tissue products. This guidance is designed to help organizations that make donor eligibility decisions by recommending practices to lower infection risks. The FDA issued this guidance immediately due to urgent health concerns, updating previous recommendations from 2007. The guidance reflects the FDA's current viewpoints but does not impose any legal obligations.

    Simple Explanation

    The FDA made a guide to help stop the spread of germs that can make people sick when they use special parts from human bodies, like cells and tissues. They want to make sure these parts are safe, especially because some germs can cause a serious illness called sepsis.

  • 2024-31544 — Recommendations To Reduce the Risk of Transmission of Mycobacterium Tuberculosis by Human Cells, Tissues, and Cellular and Tissue-Based Products; Guidance for Industry; Availability
    Type:Notice
    Citation:90 FR 1170
    Reading Time:about 7 minutes

    The Food and Drug Administration (FDA) has released a new guidance to help reduce the risk of transmitting Mycobacterium tuberculosis (Mtb) through human cells, tissues, and cellular and tissue-based products (HCT/Ps). The guidance provides recommendations for screening donors to check for signs and risk factors of tuberculosis infection. This document was issued urgently due to recent multistate outbreaks linked to Mtb transmissions from donors and aims to enhance screening until official tests are available. Although the guidance is effective immediately, the FDA is open to receiving comments on it.

    Simple Explanation

    The FDA has made a new plan to help make sure donated things from people's bodies, like cells and tissues, don't pass on a disease called tuberculosis to others. They want to start checking donors better right away and will continue to do this until special tests are ready to use.

  • 2024-31523 — Draft Guidances Relating to Recommendations To Reduce the Risk of Transmission of Relevant Communicable Disease Agents and Diseases by Human Cells, Tissues, and Cellular and Tissue-Based Products; Draft Guidances for Industry; Availability
    Type:Notice
    Citation:90 FR 1164
    Reading Time:about 9 minutes

    The Food and Drug Administration (FDA) has released three draft guidelines aimed at reducing the transmission risk of hepatitis B (HBV), hepatitis C (HCV), and HIV through human cells and tissues. These guidelines update previous recommendations to help organizations determine donor eligibility through proper screening and testing. Comments on these drafts are encouraged by February 6, 2025, and can be submitted electronically or in writing. The drafts also advise on eliminating certain donor screening questions and focus on assessing each donor's risk based on relevant factors, regardless of gender.

    Simple Explanation

    The FDA has shared new ideas on how to keep people safe by checking and testing donations of human cells and tissues to make sure they don't pass on hepatitis B, hepatitis C, or HIV. They're asking everyone to tell them what they think about these ideas by February 6, 2025.