The agency issued a draft guidance and safety communication last week in response to a recent emergence of cybersecurity breaches occurring in wirelessly connected medical devices in hospitals.
Device companies would be expected to more directly address potential cybersecurity threats in pre-market submissions under a FDA draft guidance released June 13.
The agency issued the guidance in conjunction with a safety communication to hospitals and device makers on appropriate...
The US FDA needs to know who wants a seat at the MDUFA negotiations table before discussions can begin. The agency is asking stakeholders to let it know if they plan to participate in the periodic consultation meetings before July 28.
Finland has initiated a project to improve the effectiveness of the monitoring of software intended for medical use and to ensure that software placed on its market meets the requirements set for it.
To succeed in medtech, investors must focus on patient outcomes. Gilde Healthcare says involving patients boosts product effectiveness, access and market success — making it a smart strategy in today’s strained healthcare systems.
MedTech Europe is ready to become involved and shape Europe’s Life Sciences Strategy and help drive regulatory simplification from the top to make the EU “the world’s most attractive place for life sciences by 2030.”
