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dcapera replied to the topic "Predicate Devices and the 510(k) Process" – 3 weeks, 1 day ago
The 2011 article “Medical Devices and the Public’s Health – The FDA 510(K) Clearance Process at 35 Years” raises two major concerns. First, there is doubt about whether the 510(k) process actually ensures that medical devices on the market are… Read more»
