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Speaking Of Medtech, Ep. 6: 2022 Predictions For FDA’s Device Center
In this episode of Speaking Of Medtech we’re breaking out the crystal ball to give a few predictions of what could be in store this year for industry and the US FDA’s Center for Devices and Radiological Health. From the ongoing COVID-19 pandemic to digital devices and facility inspections, there’s a lot of ground to cover.
More from Regulation
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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.
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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.
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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.
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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.”
More from Policy & Regulation
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Broad participation by EU member states in a new pilot to test a unified procedure for evaluating applications for combined drug and IVD studies shows they recognize its value, says Monique Al, vice-chair of the Clinical Trials Coordination Group.
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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.”
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The UK government’s blueprint to deliver an NHS "fit for the future" was released on July 3.