Hello Michael,
You might be able to, but would have to be very cognizant there is a fine line with assistive devices being medical devices and non-medical as many would view the intended purposes are same and overlap. Plus, if you are running a study or gathering data in support of a specific intended use for a future filing, I think might have some difficult questions to answer if challenged. It is such a fine line, you might want to get legal advice for the company, advertising, promoting, etc., rather than regulatory advice.
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Richard Vincins RAC
Vice President Global Regulatory Affairs
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Original Message:
Sent: 22-Feb-2021 11:35
From: Michael Evelegh
Subject: assistive devices
Is it possible to initially market a product as an assistive device (making no medical claims and accordingly not obtaining regulatory clearance) and then subsequently, after obtaining data in support of a specific intended use, reclassify the same product as a class I or II medical device?
Insights regarding FDA and/or Health Canada status would be appreciated.
Mike
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