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Is Quicker Really Better? The Overhaul of the 510(k) Process
By: Melissa M. Turczyn On January 19, 2011, the Food and Drug Administration (the “FDA”) announced 25 steps it intends to take before year end to improve the agency’s 510(k) clearance program for...
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There’s an App for That: FDA Issues Final Guidance on Mobile Medical Apps
By: Seth A. Mailhot The U.S. Food and Drug Administration (FDA) issued a final guidance September 25, 2013 titled, “Mobile Medical Applications.” The guidance sets out the scope of FDA’s enforcement...
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