FDA Roundup: May 10, 2024

FDA News Release

• For Immediate Release: May 10, 2024

Today, the U.S. Food and Drug Administration is providing an at-a-glance summary of news from around the agency:

• On Thursday, the FDA provided information on how to safely charge hearing aids, glucose monitors, insulin pumps, and other medical devices to avoid overheating. Medical devices with rechargeable batteries meet important medical needs, but if they are not charged properly, they can overheat, which may result in fires, or cause minor injuries or serious burns.   
• On Thursday, the FDA announced a webinar that will be held on June 27, 2024, for those interested in learning more about the final guidance Remanufacturing of Medical Devices. This final guidance is a part of the FDA’s ongoing efforts to help distinguish between remanufacturing and servicing. It clarifies whether activities performed on devices are likely "remanufacturing," which differs from servicing activities such as maintenance and repair. This clarification is intended to help ensure consistency and a better understanding of the regulatory requirements applicable to remanufacturers. Additionally, the guidance recommends information to be included in the labeling of reusable medical devices to help ensure their continued quality and safety during servicing. 
• On Thursday, the FDA announced that Sol-Millennium Medical, Inc. initiated a recall to stop using affected products, which includes unauthorized plastic syringes made in China such as “combined” syringes with needle and syringe components packaged together, low dead space (“LDS”) syringes, luer slip tip syringes, eccentric tip syringes, and syringe accessories. The FDA recommendations have not changed. The FDA will continue efforts to evaluate problems with syringes made in China and keep the public informed as new or additional information becomes available.
• On Thursday, the FDA advised consumers in Tips to Stay Safe in the Sun: From Sunscreen to Sunglasses that sun safety is always in season. Although all sunscreens help protect people from sunburn, only broad-spectrum sunscreens with a sun protection factor (SPF) of at least 15, when used as directed with other sun protection measures. help protect us from skin cancer and early skin aging caused by the sun. The FDA continues to evaluate sunscreen products to ensure that their active ingredients are safe and effective. 
• On Wednesday, the FDA’s Center for Tobacco Products (CTP) announced a webinar to be held on June 11, 2024, from 3:00 to 4:15 p.m. ET to commemorate the 10th anniversary of the award-winning “The Real Cost” youth tobacco prevention campaign. CTP will provide information about the impact of the campaign on youth tobacco use and the importance of public education to the center’s comprehensive tobacco regulation efforts. The webinar is free of charge, but prior registration is required.
• On Wednesday, the FDA alerted health care providers and facilities about the agency’s continued safety and quality concerns with Getinge/Maquet/Datascope Cardiosave Hybrid and Rescue Intra-Aortic Balloon Pump (IABP) devices and Getinge/Maquet Cardiohelp system and HLS Sets. The FDA recommends that health care providers and facilities transition away from these devices and seek alternatives, if possible. These recommendations are based on the FDA’s continued concerns that Getinge/Maquet has not sufficiently addressed the problems and risks with these recalled devices.
• On Tuesday, the FDA announced registration has opened for the June 27 public workshop to be hosted in partnership with the Reagan-Udall Foundation for the FDA, Understanding Current Use of Ketamine for Emerging Areas of Therapeutic Interest. This workshop will bring together clinicians, academic researchers, patients and patient advocates, professional organizations, and federal partners to explore such topics as: the scope of ketamine use, including approved products and compounded products, for emerging areas of therapeutic interest; potential safety concerns; and online promotion of and access to ketamine.
• On Tuesday, the FDA announced a risk-based decision based on its review of safety and quality data and information and does not expect the developer of PrecisePRP Equine (equine leucoreduced allogeneic pooled freeze-dried platelet-rich plasma) to submit an application for approval prior to marketing. PrecisePRP Equine provides a species-specific source of concentrated platelets in plasma for injection directly into a horse’s joint (intra-articular injection). PrecisePRP Equine is the second animal cell, tissue, and cell- and tissue-based product (ACTP) intended for intra-articular use to undergo FDA review and receive this determination, and it is the first such product for use in horses.
• On Monday, the FDA issued a Federal Register notice announcing a meeting of the Tobacco Products Scientific Advisory Committee (TPSAC) scheduled for June 26, 2024, at the FDA White Oak campus. The committee will discuss the renewal of a risk modification order, submitted by Swedish Match USA, Inc. for 8 loose snus and portioned snus products. Additional discussion about broader Modified Risk Tobacco Products program developments related to the conceptualization and measurement of consumer understanding will also occur.