FDA Roundup: December 8, 2023

SILVER SPRING, Md., Dec. 8, 2023 /PRNewswire/ — Today, the U.S. Food and Drug Administration is providing an at-a-glance summary of news from around the agency: 

On Wednesday, the FDA announced that eSTAR is now available for voluntary use for certain PMA Submissions. eSTAR is an interactive PDF form that guides applicants through the process of preparing a comprehensive medical device submission. eSTAR is intended to enhance the incoming quality of submissions for a wide range of medical devices by helping to ensure submitters provide quality, comprehensive data for premarket review.

The updated eSTAR Template includes a guide that follows the recommendations noted in the final guidance: Cybersecurity in Medical Devices: Quality System Considerations and Content of Premarket Submissions. The recommendations are intended to promote consistency, facilitate efficient premarket review, and help ensure that marketed medical devices are sufficiently resilient to cybersecurity threats.

On Tuesday, the FDA updated the Public Health Advisory on the investigation of elevated lead levels in cinnamon applesauce pouches, reporting that an onsite inspection has been initiated at the Austrofoods facility in Ecuador and ingredient sampling is underway. The FDA’s update also includes updated adverse event report numbers for the FDA, as well as case count information reported by the CDC. More information about CDC’s case definition and case counts is available on their advisory (published on 12/5/2023).

 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.

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SOURCE U.S. Food and Drug Administration