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Healthcare › FDA Warning Letters › Medical Devices

Arnall Golden Gregory LLP

Step by Step: FDA Cracks Down on Unauthorized Medical Device Modifications

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The Food and Drug Administration recently issued a Warning Letter concerning unauthorized modifications made to a previously cleared medical device (i.e., 510(k)). ...more

Arnall Golden Gregory LLP

Don’t Go Changing . . . Unless You Ask FDA

Arnall Golden Gregory LLP on

The Food and Drug Administration recently issued a Warning Letter to a medical device manufacturer for making significant changes to its 510(k)-cleared products for uses outside the scope of the 510(k) clearance, among other...more

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