Unintended consequences of changing the current 510K system for ?moderate risk? devices

This is a guest post from Rick Lifsitz, a colleague of mine from MedPharma Partners and a serial entrepreneur . On July 29 an expert panel assembled by the Institute of Medicine found that the current regulatory framework for ?substantially equivalent? devices (known as the FDA 510K process) was flawed and called for it to [...]

Source: http://feedproxy.google.com/~r/HealthBusinessBlog/~3/JHmtHLDAHmk/

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