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What are the FDA 510(k) premarket notifications?

April 26, 2017fda notifications premarket

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What are the FDA 510(k) premarket notifications?

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The FDA has established classifications for approximately 1,700 different generic types of devices and grouped them into 16 medical specialties referred to as panels. Each of these generic types of devices is assigned to one of three regulatory classes based on the level of control necessary to assure the safety and effectiveness of the device.