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This excerpt is from the management report titled “Using Real-World Evidence in Drug and Device Submissions,” based on a webinar from FDAnews, A WCG Company. The presenters were Kristin Zielinski Duggan and Sally Gu of the Washington, D.C., law firm Hogan Lovells. Read More
In recalls the FDA describes as the most serious type, Inari Medical is updating its directions for use of its ClotTriever XL catheter and Medline is warning against use of the syringes included in several of its convenience kits. Read More
Debfitech has issued an urgent medical device safety removal letter to its customers of the RMU-2000 ARM XR chest compression device, which provides chest compressions on adults whose hearts suddenly stop, directing that the device be removed from use. Read More
In this edition of Quick Notes EU, we note a revised EMA guideline on pharmacovigilance, a call by EMA to revoke authorization of Ocaliva for treatment of primary biliary cholangitis — an autoimmune disease that destroys the liver’s bile ducts, a European Commission survey on electronic instructions for use for medical devices, a new pilot program for developers of orphan medical devices, and a thumbs down in the UK for Enhertu for treatment of HER2-low breast cancer by the National Health Service. Read More
Globus Medical, a manufacturer of surgical robots, received an FDA Warning Letter after the company’s inadequate response failed to address findings regarding screws misplaced during surgeries, lack of correction and preventive action (CAPA) plans and failure to file medical device reports (MDR). Read More
The FDA outlines what goes into a De Novo device request filed using the electronic Submission Template and Resource (eSTAR), in a final guidance released Thursday. Read More
ICU Medical is updating the use instructions for the Plum 360, Plum A+ and Plum A+3 Infusion Systems due to a manufacturing defect of the batteries, which can substantially diminish the life of the batteries and could put patients at risk. Read More
The FDA’s efforts to actively oversee the safety of medical devices after they’ve hit the market have begun to bear fruit, with the agency making strides toward setting up a postmarket surveillance system and planning to kick it into gear by the end of 2024, a Government Accountability Office (GAO) analysis finds, but two core challenges remain. Read More
Breas Medical has initiated a nationwide correction for 8,186 of its Vivo 45 LS ventilator devices after internal testing identified the potential for short term elevated levels of formaldehyde exposure to users under specific conditions. Read More
A recent FDA Warning Letter illustrates to sponsors the importance of properly managing monitoring responsibilities and having a thorough site activation process. In this article, we’ll examine the letter received by the sponsor of a multisite trial of a device for preventing recurrent ischemic stroke and discuss how problems could have been avoided in the first place. Read More
Abiomed has recalled certain Impella CP with SmartAssist heart pumps after nine devices in a single lot failed a company inspection — but were inadvertently released to customers — the FDA announced. Read More