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A Medical Device is an instrument, apparatus, implant, in vitro reagent, or similar or related article that is used to diagnose, prevent, or treat disease or other conditions. A device cannot provide treatment through chemical action. In both the U.S. and Canada, distinct sets of statutory and regulatory provisions apply to medical device research. These provisions place specific requirements on an IRB/REB, including a core determination: whether the device presents a “non-significant risk.” com

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