WASHINGTON, D.C. — The U.S. Food and Drug Administration (FDA) has announced several critical developments spanning food safety, medical device oversight, and healthcare innovation. These updates reflect the agency’s ongoing commitment to public health and regulatory transparency.
On Friday, the FDA announced the cessation of 35 food contact notifications (FCNs) related to per- and polyfluoroalkyl substances (PFAS). These notifications, previously allowing the use of PFAS for grease-proofing coatings in paper-based packaging, were determined abandoned after manufacturers ceased production or use.
On Thursday, a safety alert was issued for oysters harvested from Washington State’s Hammersley Inlet between December 2 and December 17, 2024. A norovirus outbreak linked to these shellstock oysters prompted a recall by Washington State and an FDA advisory against consuming, selling, or serving the affected products.
The agency also released a new medical device early alert on Tuesday as part of its pilot program to improve transparency and expedite communication about high-risk recalls. This alert focused on solution sets, fluid delivery systems, and single-use blood circuits, aiming to ensure timely notification to healthcare providers and consumers.
Looking ahead, the FDA announced a virtual public meeting scheduled for January 30, 2025, to provide updates on the Center for Devices and Radiological Health’s Real-World Evidence program. The meeting will explore data-driven methods advancing regulatory acceptance and product approvals.
Additionally, the FDA unveiled the Idea Lab last week. This initiative reimagines the role of the home in healthcare, particularly for individuals managing chronic conditions like diabetes. The Idea Lab features innovative tools, including a virtual reality prototype named Lilypad™, designed to demonstrate how medical devices can integrate into diverse home environments.
These updates highlight the FDA’s multifaceted approach to addressing food safety risks, advancing medical device regulation, and fostering innovation to enhance public welfare.
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