FDA Roundup: November 15, 2024

SILVER SPRING, Md., Nov. 15, 2024 /PRNewswire/ -- Today, the U.S. Food and Drug Administration is providing an at-a-glance summary of news from around the agency:

    --  Next week, the World Health Organization's Member State Mechanism on
        Substandard and Falsified Medical Products will hold its 13th meeting in
        Geneva, Switzerland. Ahead of the Nov. 20-22 meeting, FDA Associate
        Commissioner Mark Abdoo, a vice-chair of the Mechanism's Steering
        Committee, published a blog on Nov. 7 on how to make the Mechanism more
        effective.


    --  Today, the FDA issued a Letter to Health Care Providers about safety
        concerns with Getinge/Maquet VasoView HemoPro Endoscopic Vessel
        Harvesting (EVH) Systems, and a supply concern for EVH devices. On Sept.
        20, 2024, Getinge/Maquet announced a voluntary recall for removal of all
        unused VasoView HemoPro 1.5 devices due to the risk of silicone
        detaching from the jaws of the harvesting tool during use. The removal
        of VasoView HemoPro 1.5 from use may interrupt the supply of EVH
        devices. The FDA has updated the medical device shortage list to include
        EVH devices (product code GEI). Acknowledging that alternative options
        are limited, the FDA is providing recommendations for health care
        providers and facilities.


    --  On Thursday, the FDA released updated guidance for the Voluntary
        Qualified Importer Program (VQIP), part of the FDA Food Safety
        Modernization Act (FSMA). The revisions streamline processes, increase
        flexibility, and improve program efficiency. Key updates include a new
        inspection approach that may reduce user fees, the ability for
        participants to add suppliers and foods throughout the year, and an
        extended deadline for enrollment steps. For more information, contact
        fsmavqip@fda.hhs.gov or see the updated VQIP Guidance for Industry.


    --  On Wednesday, the FDA posted a new video in the "FDA In Your Day"
        series. In this video, FDA's Chief Medical Officer Dr. Hilary Marston
        discusses where to find recall information on FDA's website.


    --  On Wednesday, the FDA updated the outbreak advisory for E. coli O157:H7
        infections linked to onions sold at McDonald's restaurants. The FDA
        continues to investigate in collaboration with the Centers for Disease
        Control and Prevention, the U.S. Department of Agriculture's Food Safety
        and Inspection Service, state partners, and implicated firms.
    --  On Tuesday, the FDA granted marketing authorization for the novel
        technology of the Steris VERIFY RESI-TEST SLIDE-THRU Cleaning Process
        Protein Indicator. This device is a qualitative protein detection test
        used to detect residual protein in the soil extracted from a brush used
        on the lumens of medical devices after cleaning and prior to high-level
        disinfection or sterilization. The presence of the residual proteins is
        assessed through solution color change. The device is used in medical
        care facilities for the cleaning and reprocessing of medical devices.

Additional Resources:

    --  FDA Newsroom

Media Contact: FDA Office of Media Affairs, 301-796-4540
Consumer Inquiries: 888-INFO-FDA

The FDA, an agency within the U.S. Department of Health and Human Services, protects the public health by assuring the safety, effectiveness, and security of human and veterinary drugs, vaccines and other biological products for human use, and medical devices. The agency also is responsible for the safety and security of our nation's food supply, cosmetics, dietary supplements, radiation-emitting electronic products, and for regulating tobacco products.

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SOURCE U.S. Food and Drug Administration