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  1. HIV (Human Immunodeficiency Virus)

HIV Prevention

Blood Bag

There are a number of areas where the FDA impacts upon prevention of the transmission of HIV. These include:

Blood Safety

  • Helping to ensure the safety of the nation’s blood supply by minimizing the risk of infectious disease transmission and other hazards. This is accomplished through registration and inspection of blood banks and other blood processing facilities, licensing and inspection of plasma centers, evaluating and licensing biologics manufacturing firms who make blood derivative products, such as clotting factor, and developing necessary regulations, compliance programs, and guidelines to protect the blood industry. More information on Blood Donor Deferral

Barrier Products

  • Surveillance and quality assurance of barrier products, including condoms, the female condom, dental dams, surgical and medical gloves, etc. In addition to monitoring the quality and integrity of these products, the agency works with sponsors to develop and test new materials (such as the non-latex condoms made of urethane plastic) and to label products for new uses.
    More Information: Barrier Products


  • Working with industry and government developers of both preventive and therapeutic vaccines for HIV. These include Recombinant Live Vectors, Nucleic Acid-based vaccines, Inactivated HIV-1, Retroviral Vectors, Envelope Proteins/Peptides, DNA Plasmid, and Core Proteins/Peptides.
    More Information: Vaccines


  • Working with sponsors, NIH, and other researchers to develop practical topical microbicides to prevent the spread of HIV by creating a chemical barrier to transmission of live virus.

Medical Equipment Safety

  • Ensuring proper device sterilization and disinfection in reprocessing of medical devices between patients by health care facilities to prevent transmission of HIV/AIDS through:

    • Review of premarket submissions, compliance actions and/or equipment for reprocessing of  reusable devices
    • Regulatory laboratory testing of germicides, sterilizers and related products
    • Laboratory activities including research on the activation of the HIV virus by radiation and on the inactivation of microorganisms through the use of sterilizing or disinfecting agents

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