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The EU is considering a proposal to delay by several years the compliance deadline for its Medical Device Regulation (MDR) which was to go into effect May 26, 2024, as there are insufficient resources to meet the deadline required by law. Read More
The FDA explores the blurred regulatory line between medical device software and non-device software functions in a new report that concludes the benefits of non-device software outweigh the risks.
In a nod to the increasing development of three-dimensional visualization tools, the FDA has created a new page on its website devoted to listing augmented and virtual reality medical devices.
The FDA published a draft guidance Thursday that lays out a risk-based framework to guide review staff and device manufacturers on what human factors information to include in a marketing submission to the Center for Devices and Radiological Health (CDRH).
To help manufacturers better understand and make use of the FDA’s four-year-old Voluntary Summary Malfunction Reporting (VMSR) program, the agency released draft guidance on Thursday to explain — but not change — the conditions of the VMSR. Read More
The U.S. Patent Trial and Appeal Board (PTAB) stood with Apple in its complaint that former partner AliveCor’s claims on the technology behind wearable Afib detection were unpatentable.
The EU Medical Device Coordination Group (MDCG) has proposed a new definition of hybrid audits, suggesting that there should be at least one auditor in a facility premises — at some point — during an audit by a notified body, with off-site team members participating using information and communication technologies.
The FDA has approved new safety labeling for Endologix’s AFX2 endovascular graft systems, which is used to treat patients with abdominal aortic aneurysm (AAA).
The FDA should take a page out of one online retail giant’s book, says Commissioner Robert Califf, as it works to update its technology infrastructure and make its processes and interactions with industry as efficient as possible. Read More