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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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Moves are at last underway for a more specific focus on orphan and pediatric devices. They are a start; but experts are calling for more to support this sector.
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Post-market surveillance regulations for medtech system users in Great Britain coming into force on 16 June will make new data requirements under new compliance deadlines.
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HHS Secretary Robert F. Kennedy, Jr. is asking the public to help cut waste across the government’s health agencies. Kennedy announced a 60-day comment period allowing the public to take part in a broader federal initiative to reduce regulations and increase transparency.
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The intricate assembly of medical devices, often involving over 1,000 globally sourced components, faces severe disruption due to new US tariffs. These barriers could halt production and devastate small and medium-sized enterprises (SMEs), MedTech Europe’s CEO, Oliver Bisazza, warns in an interview with Medtech Insight.
More from Policy & Regulation
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Post-market surveillance regulations for medtech system users in Great Britain coming into force on 16 June will make new data requirements under new compliance deadlines.
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A battle may be forming over the 2027 FDA user fee reauthorizations. At a conference Friday, Democratic Rep. Jake Auchincloss supports them for their effectiveness, while Deputy FDA Commissioner Grace Graham echoed criticisms from HHS Sec. Kennedy, among others, in calling for reform to ensure public trust.
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Health and Human Services Secretary Robert F. Kennedy Jr. emphasized administrative cost reductions and defended budget decisions during a Senate hearing on HHS funding. Some senators, however, expressed concerns over the impacts spending cuts had on essential health programs.