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Archives for August 2015

Substantial Equivalence: The FDA, CMS, and Patents

This 19-minute compilation from 2014’s 10x Medical Device Conference features Ed Black, Tom KraMer, Pat Kullmann, Doug Limbach, and Bruce MacFarlane on the tricky path for device innovation.

On one hand, you want to be THE SAME.
• If you’re substantially equivalent to an existing device, you get to save on clinical trials.
• And you likely shorten the time for FDA clearance.

On the other hand, you want to be DIFFERENT.
• If you’re materially the same as an existing device, why should CMS give you a reimbursement code?
• If you’re materially the same, do you deserve a patent?

Click for the slides and transcript »