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The Advanced Medical Technology Association (AdvaMed) wants the Food and Drug Administration (FDA) to understand that medical device manufacturers want clarity on FDA’s heightened focus on [...]

FDA’s Center for Devices and Radiological Health (CDRH) provided a glowing self-assessment in a recent report. The CDRH met its 2016 strategic objectives for several initiatives pertaining [...]

Corrective and preventive action (CAPA) plans — along with document management and risk management — remain a key focus of FDA inspectors. Even a cursory review of FDA warning letters [...]