FDA Roundup: December 8, 2023

FDA News Release

• For Immediate Release: December 08, 2023

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).