Medical Device Enforcement and Quality Report

By Anne K. Walsh & Adrienne R. Lenz, Senior Medical Device Regulation Expert — 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. The Report provides five conclusions: The FDA has increased its oversight through additional device inspections. The FDA has taken a targeted, risk-based enforcement approach to address specific device areas of concern. The FDA’s focus on violative products and adverse event reporting during inspections has led to an increase in voluntary recalls and adverse event reporting. Most firms have corrected violations on follow-up inspection. The…

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