US FDA user fees will go up by almost 12% for fiscal 2025, with PMAs set to cost $540,783 and 510(k)s at $24,335.
Medical device user fees will jump almost 12% for fiscal 2025, the US Food and Drug Administration said in a Federal Register notice set to be published on 31 July.
This will put PMA fees for companies not eligible for a small-business discount at $540,783, up from $483,560 in fiscal...
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.”
