FDA News Summary for January 3, 2025 “`

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137ab69e760a7bb9948f139c8e2adae2 FDA Roundup: January 3, 2025

SILVER SPRING, Md., Jan. 3, 2025 — The U.S. Food and Drug Administration (FDA) offers a summary of recent agency news:

  • The FDA declared 35 food contact notifications (FCNs) related to per- and polyfluoroalkyl substances (PFAS) abandoned. Manufacturers ceased production, supply, or use of these substances, previously used in grease-proofing coatings for paper and paperboard food packaging.
  • The FDA warned restaurants, retailers, and consumers in Oregon and Washington against consuming shellstock oysters harvested from December 2 to December 17, 2024, by Ruco’s Shellfish (WA-1995-SS) from Hammersley Inlet, Washington. This follows a Washington State recall due to a norovirus outbreak.
  • The FDA released the latest early alerts for solution sets, fluid delivery sets, and single-use blood circuits. These are part of the Center for Devices and Radiological Health’s pilot program to improve the medical device recall process, enhancing transparency and timeliness of communication.
  • The FDA announced a webinar on Thursday, January 30, 2025, 11 a.m.-12 p.m. ET, to discuss updates to the Center for Devices and Radiological Health’s (CDRH) Real-World Evidence program. Registration closes Tuesday, January 29, 2025, at 4 p.m. ET. Comments can be submitted under docket FDA-2024-N-5760 by March 3, 2025.
  • The FDA launched an Idea Lab, part of the Home as a Health Care Hub initiative. It features a virtual reality prototype, Lilypad™, showcasing how medical devices integrate into home environments for people with diabetes. The lab offers insights from patients, caregivers, providers, and experts.

    “These insights and resources are intended to help the FDA, innovators, and other interested parties better understand how current medical devices fit into people’s homes and lives,” said Michelle Tarver, M.D., Ph.D., director of the Center for Devices and Radiological Health.

Additional Resources: 

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Media Contact: , 301-796-4540
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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