It’s Here – the Comment Period for 510(k) Draft Guidance is Open

As we all know, there has been a lot of angst in the device industry as the FDA evaluates what to do next with regards to 510(k) reform.  Last year we posted a blog describing the challenges and uncertainty around 510(k) reform. We’ve been closely monitoring CDRH Plan of Action for 510(k) and were pleased to see that the FDA has just released draft guidance for Evaluating Substantial Equivalence in Premarket Notifications.  The industry has 120 days to provide comments to the agency and is encouraged to do so in order to help shape the final guidance. What constitutes ‘substantial equivalence’ and a ‘predicate device’ is key for any medical device company as they bring next generation products to market.  This draft guidance is intended to replace prior revisions from 1986 and 1998 to reflect current thinking in the agency with modern technology and represents a window into the future of the device industry.  As such, this draft guidance is something that every device professional should seek to understand and monitor in the coming months to get a head-start on what’s in store for the industry.

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