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FDA review times under 510(k) process improve, report says
An FDA report issued this week says about 80% of medical devices submitted under the 510(k) process were approved this year, compared with 73% two years ago. The agency said this was due in part to better submissions from manufacturers. The report also notes the average time for a device to receive 510(k) clearance dropped last year, the first time in seven years.
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