A common question for researchers is, “Does my study involve a medical device?” The answer is not always straightforward. The definition of medical device is broad enough to include anything from a tongue depressor to an advanced robotic arm that assists with surgery.
A Medical Device:
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.”
Quorum understands the complexities of device research. Our boards have extensive experience with devices, our regulatory team can help determine the appropriate classifications for your product, and our support staff can guide you through the particulars of reviewing device research.
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