FDA Updates: November 15, 2024

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95bb480d8682116975ea65f2bee58b25 FDA Roundup: November 15, 2024

SILVER SPRING, Md., Nov. 15, 2024 — The U.S. Food and Drug Administration (FDA) offers a brief summary of recent agency news:

  • The World Health Organization’s Member State Mechanism on Substandard and Falsified Medical Products will convene its 13th meeting in Geneva, Switzerland, November 20-22. FDA Associate Commissioner Mark Abdoo, a vice-chair of the Mechanism’s Steering Committee, recently published (on November 7) an article on enhancing the Mechanism’s effectiveness.
  • The FDA issued a safety communication addressing concerns regarding Getinge/Maquet VasoView HemoPro Endoscopic Vessel Harvesting (EVH) Systems and a supply shortage of EVH devices. Following Getinge/Maquet’s September 20, 2024, voluntary recall of unused VasoView HemoPro 1.5 devices due to potential silicone detachment, the FDA updated its communication to include EVH devices (product code GEI) and offer guidance to healthcare providers.
  • The FDA updated its guidance for the Voluntary Qualified Importer Program (VQIP) under the Food Safety Modernization Act (FSMA). These revisions aim to streamline processes, improve flexibility, and enhance efficiency. Key changes include a new inspection approach that might reduce user fees, the ability for participants to add suppliers and foods year-round, and an extended deadline for enrollment.
  • A new video in the FDA’s educational series was released, featuring FDA Chief Medical Officer Dr. Hilary Marston explaining where to find recall information on the FDA website.
  • The FDA updated its information on E. coli O157:H7 infections linked to onions sold at McDonald’s restaurants. The investigation continues in collaboration with various partners.
  • The FDA granted marketing authorization for Steris VERIFY RESI-TEST SLIDE-THRU Cleaning Process Protein Indicator, a qualitative protein detection test used in medical facilities for cleaning and reprocessing medical devices.

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Consumer Inquiries: 888-INFO-FDA 

The FDA, part of the U.S. Department of Health and Human Services, ensures the safety, effectiveness, and security of various products, including drugs, vaccines, medical devices, food, cosmetics, and tobacco products.

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SOURCE U.S. Food and Drug Administration

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