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Articles about entrepreneurship, traveling, business and life from Alvin Tai

11/02/2014
by Alvin
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Evaluating Substantial Equivalence – FDA Guidance for 510k

In July 2014, the FDA released a new draft of their guidance document for evaluating substantial equivalence for 510k submissions: http://www.fda.gov/downloads/MedicalDevices/DeviceRegulationandGuidance/GuidanceDocuments/UCM284443.pdf This is a much needed guidance document because every medical device company that I’ve worked with struggle with identifying … Continue reading