FDA Roundup: November 15, 2024
Regulatory2024-11-15
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- For Immediate Release:
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.
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Boilerplate
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 (FDA.gov)
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