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FDA Proposes More Closely Regulating Some Surgical Mesh Kits
The Wall Street Journal (online registration required): Surgical mesh kits used to repair a condition called pelvic organ prolapse should be more closely regulated, the Food and Drug Administration announced on Tuesday, signaling heightened recognition of the safety issues associated with the devices currently on the market.
The FDA's proposed changes, if finalized, would reclassify the medical devices as high risk instead of moderate risk, and would be significant because companies would...
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