FierceMedicalDevices’ Damian Garde shares that the amount of medical device inspections under President Obama’s terms has skyrocketed up 47%, hitting eight year highs. The number of warning letters handed out by the FDA is correlated with this growing number as well. The growing rate of inspections and warning letters does not seem to be slowing; the agency is requesting $870 million to run the Center for Devices and Radiological Health next fiscal year. It is also clear that the agency is targeting manufacturing processes, making up 60% of the warning letters handed out. While the rest was split between design, management, and document control. How large of a role do you think the FDA should play in inspections? Read the full article here.
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