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The FDA fired off Warning Letters to four companies — two in China and two in the U.S. — for marketing CPAP cleaning and sanitizing devices without clearance or approval. Read More
The FDA has reclassified four types of devices from the automatic class III designation to class II (special controls), and in each case the agency says the reclassification will provide a reasonable assurance of safety and effectiveness as well as enhance patients’ access to beneficial innovative devices. Read More
Sponsors appear more informed and prepared than sites for the upcoming changes to the ICH E6 — Good Clinical Practices guideline, according to a newly published survey by Avoca, a WCG company. Read More
The FDA has finalized guidance on the Voluntary Malfunction Summary Reporting (VMSR) program that allows manufacturers to submit medical device reports (MDRs) for certain low-risk devices to the agency on a quarterly basis instead of sending individual malfunction reports. Read More
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