[Editor's note: This story was updated on April 4 with more specific information from US FDA.]
A roughly 20% increase in the US FDA’s device center’s proposed budget for fiscal year 2020 over FY 2019 would...
US FDA intends to use device-center dollars in its fiscal year 2020 budget on medical product safety, bolstering cybersecurity, device oversight modernization, and an initiative called “Bring Medtech Manufacturing Home,” among other priorities.
[Editor's note: This story was updated on April 4 with more specific information from US FDA.]
A roughly 20% increase in the US FDA’s device center’s proposed budget for fiscal year 2020 over FY 2019 would...
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.”