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Creating a new medical device classification, the FDA has granted Xenex Disinfection Services’ LightStrike+ high-intensity, broad-spectrum ultraviolet (UV) light robot a De Novo marketing authorization. Read More
The 13 new draft guidelines focused on mergers and acquisitions from the FTC and the Department of Justice (DOJ) go into a lot of detail about what constitutes anticompetitive practices, but they don’t do enough to tell companies what is acceptable when they’re planning a merger or acquisition. Read More
Medtronic MiniMed has been accused of transmission and disclosure of HIPAA protected personally identifiable information (PII) and protected health information (PHI) from its InPen diabetes management system to Google, Crashlytics and other tracking tools. Read More
Upcoming events in the coming weeks include nine FDA advisory committee meetings as well as the GMP Quality Management vSummit, the WCG MAGI@Home Clinical Research Conference 2023, the 18th Annual Inspections vSummit and webinars from FDAnews, a WCG company, on calculating sample sizes for verification and validation activities and medical device counterfeiting. Read More
The UK’s Medicines and Healthcare products Regulatory Agency (MHRA) is seeking public feedback on a plan that would end regulatory reciprocity between the UK and the EU for drug and device review and approvals. Read More
The Patient Engagement Advisory Committee (PEAC) — FDA’s only advisory committee comprised solely of patients, caregivers, and patient advocates — is seeking guidance on improving access to home-use medical devices in a diverse patient population, from device design to clinical trials and marketing in an all-day meeting on Sept. 6. Read More
Over the past week, the FDA issued guidance on its intention not to take action to enforce the requirements of DSCSA until Nov. 27, 2024, recommendations on system attributes necessary to enable secure tracing of products at the package level under DSCSA, formal dispute resolution on pharmaceutical GMP scientific and technical issues, and use of real-world data to support regulatory decision making. Read More
The FDA has deemed as class I another in a series of voluntary recalls from Getinge/Maquet/Datascope for various models of its Cardiosave Hybrid and Cardiosave Rescue intra-aortic balloon pump (IABP), this time for the potential of the device to overheat and shut down. Read More
The FDA has deemed Hamilton Medical’s recall of certain of its ventilators as class I, the most serious type of recall as use the device may lead to serious injury or death. Read More