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The FDA published a draft guidance Thursday that lays out a risk-based framework to guide review staff and device manufacturers on what human factors information to include in a marketing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and make use of the FDA’s four-year-old Voluntary Summary Malfunction Reporting (VMSR) program, the agency released draft guidance on Thursday to explain — but not change — the conditions of the VMSR.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.
An FDA inspection of Polar Products’ device manufacturing plant in Stow, Ohio, found that the facility lacked proper design and other records and did not adequately evaluate incoming product or its suppliers.
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).