The FDA has released guidance for sponsors of devices with cybersecurity risks on what they should include in their premarket submissions, as well as considerations for device design and labeling. Read More
The FDA and the Department of Homeland Security signed a memorandum of agreement that expands their collaboration for medical device cybersecurity. Read More
Some medical devices that don’t have an intended medical purpose — such as non-prescription colored contact lenses — will be required to comply with the EU’s new regulations for medical devices by May 26, 2020, the UK’s Medicines and Hea... Read More
Cair LGL, a manufacturer of medical devices and equipment for hospitals, failed to properly submit MDRs, adequately maintain complaint files or evaluate complaints, the FDA said following a February inspection of its facility in Lissieu,... Read More
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