Medical Device Enforcement and Quality Report

In light of recent criticism of FDA’s oversight of medical devices, it is curious why FDA did not release a report touting the success of its enforcement activities with the same fanfare as its report on its plan to modernize the 510(k) program, which we reported on here. The Medical Device Enforcement and Quality Report (Report), available here, claims FDA’s increased inspections have led to improved compliance by industry.
— Read on www.fdalawblog.net/2018/12/medical-device-enforcement-and-quality-report/

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