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FDA Schedules Public Meeting on Premarket Clearance Process for Medical Devices
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FDA Schedules Public Meeting on Premarket Clearance Process for Medical Devices
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January 22, 2010, 05:01:27 PM »
FDA Schedules Public Meeting on Premarket Clearance Process for Medical Devices
22 January 2010, 3:52 pm
The U.S. Food and Drug Administration announced today that it has scheduled a public meeting on Feb. 18, 2010, to discuss key challenges related to the premarket notification, or 510(k) process, used to review and clear certain medical devices marketed in the United States. The FDA receives more than 3,000 510(k) submissions each year.
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FDA Schedules Public Meeting on Premarket Clearance Process for Medical Devices