FDA Roundup: January 3, 2025

SILVER SPRING, Md., Jan. 3, 2025 /PRNewswire/ -- Today, the U.S. Food and Drug Administration is providing an at-a-glance summary of news from around the agency: 

• Today, the FDA issued a notice in the Federal Register with its determination that 35 food contact notifications (FCNs) related to per- and polyfluoroalkyl substances (PFAS) are no longer effective. The agency has determined that the uses of these 35 FCNs have been abandoned because the manufacturers or suppliers have ceased production, supply, or use of the food contact substances. The 35 FCNs had previously authorized food contact substances used for grease-proofing coatings applied to paper and paperboard packaging to prevent leaking of oil and water.
  
  
• On Thursday, the FDA issued a safety alert for restaurants, retailers, and consumers in Oregon and Washington. The alert advises against consuming, selling, or serving shellstock oysters harvested from December 2 to December 17, 2024, by Ruco's Shellfish (WA-1995-SS) from a specific area of Hammersley Inlet, Washington. This advisory is in response to a recall initiated by Washington State, following a norovirus outbreak associated with these oysters.
  
  
• On Tuesday, the FDA issued the latest medical device early alert for solution sets, fluid delivery sets, and single use blood circuits. These early alerts are part of the Center for Devices and Radiological Health's communications pilot to enhance the medical device recall program. The pilot aims to increase transparency and minimize the time between the FDA's initial awareness and public communication of potentially high-risk medical device removals or corrections and provide more timely communication to consumers and health care providers.
  
  
• On Monday, the FDA announced a virtual public meeting that will be held on Thursday, January 30, 2025, 11 a.m.-12 p.m. ET to share the Center for Devices and Radiological Health's (CDRH) recent Real-World Evidence program updates and activities. As part of CDRH's Medical Device User Fee Amendments 2022 (MDUFA V) commitments, the Center continues to develop real-world data and real-world evidence methods and policies to advance regulatory acceptance for premarket submissions, including expanded indications for use and new clearance/approval of new devices. The registration deadline is 4 p.m. ET on Tuesday, January 29, 2025. Comments may be submitted under docket FDA-2024-N-5760 at www.regulations.gov by March 3, 2025.
  
  
• On Monday, the FDA unveiled an Idea Lab, as part of the Home as a Health Care Hub initiative, to help innovators, providers, and patients reimagine the home as an integral part of the health care system. The Idea Lab includes a virtual reality prototype, named Lilypad™, which will give users an immersive experience inside various affordable homes of representative people living with diabetes. The Idea Lab will also include insights from patients, caregivers, providers and experts, tours of different types of affordable housing environments, and landscape research into design opportunities ripe for innovation.
  
  "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: 

• 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.

SOURCE U.S. Food and Drug Administration