FDA Roundup: January 19, 2024

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 marketing denial orders (MDOs) to Shenzhen Youme Information Technology Co. Ltd. for two Suorin brand e-cigarette products and to Fontem US, LLC for blu PLUS+ brand e-cigarette products. The companies must not market or distribute these products in the United States or they risk FDA enforcement action. 
• On Thursday, the FDA and the Centers for Medicare & Medicaid Services (CMS) issued a joint statement reiterating mutual support of the FDA’s oversight of laboratory developed tests (LDTs), including the analytical and clinical validity of these tests. LDTs help physicians make critical decisions about their patients’ care. According to the Centers for Disease Control and Prevention, approximately 70% of health care decisions depend on laboratory test results. Because of the important role of laboratory tests in health care decisions, it is essential to ensure these tests work. Both the FDA and the CMS believe patients and providers need to have confidence that laboratory tests work.
• On Thursday, the FDA issued a safety communication to alert patients, caregivers, and health care providers about certain recalled ResMed Ltd (ResMed) masks used with bilevel positive airway pressure (also known as Bilevel PAP, BiPAP, or BPAP) machines and continuous positive airway pressure (CPAP) machines. These recalled masks have magnets that can cause potential injuries or death when the magnets interfere with certain implanted metallic medical devices or metallic objects in the body. These potential adverse events can occur in people who use the masks or in people near a person using the mask. Additionally, the recalled ResMed masks may be used with other manufacturers’ BiPAP and CPAP machines. Users of any BiPAP or CPAP machine should check to see if their mask is one of the recalled ResMed masks.
• On Wednesday, the FDA issued a Safety Alert advising restaurants and retailers not to serve or sell and consumers not to eat certain oysters from Baja California, Mexico potentially contaminated with norovirus.
• On Wednesday, the FDA’s Center for Devices and Radiological Health (CDRH) issued its 2023 Annual Report. 2023 was a transformative year for CDRH. The Center officially turned a corner on the COVID-19 pandemic and moved toward a more sustainable workload, including prioritizing normal review timelines for all incoming premarket submissions. In 2023, CDRH authorized the highest number of novel medical devices on record (excluding EUAs). In addition to highlighting medical device authorizations, the 2023 Annual Report illustrates the many ways CDRH continues to advance innovation and ensure people have access to safe, effective, and high-quality medical devices and radiation-emitting products.
• On Wednesday, the FDA announced that Emergent Biosciences will extend the shelf-life of Narcan 4 milligram (mg) naloxone hydrochloride nasal spray products from 3-years to 4-years. The extension request is the latest of multiple steps that the FDA has taken to reduce overdose-related deaths. 
• On Tuesday, the FDA issued marketing denial orders (MDOs) to Shenzhen IVPS Technology Co., Ltd for 22 SMOK brand e-cigarette products. The denied products include devices, pods, atomizers, and cartridges, which are part of an e-cigarette system marketed without an e-liquid. The company must not market or distribute these products in the United States or they risk FDA enforcement action. 
• On Tuesday, the FDA alerted patients and health care providers about health risks associated with the Equinoxe Shoulder System joint replacement devices. These devices were manufactured by Exactech between 2004 and August 2021 and were packaged in defective bags. The defective bags were missing one of the oxygen barrier layers that protect the devices from oxidation, a chemical reaction with oxygen that can degrade plastics over time. Oxidation can lead to faster device wear or failure, and device component cracking or fracture. These issues could lead people with the device to need additional surgery to replace or correct the implanted Equinoxe Shoulder System. The FDA issued a safety communication on March 23, 2023, about a similar issue with other Exactech joint replacement devices.
   

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