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In a new final guidance “Use of International Standard ISO 10993-1, ‘Biological evaluation of medical devices - Part 1: Evaluation and testing within a risk management process’”, the FDA provides information on using ISO 10993-1 for evaluating devices that come into direct contact with intact skin, including the types of information that should be included in premarket submissions. Read More
Device manufacturers should be more conscious of potential demographic bias in clinical trials, which could show up as differences in safety, effectiveness or ease of use, according to members of the FDA’s Patient Engagement Advisory Committee (PEAC). 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
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
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