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FDA improves 510(k) clearance times!



All sounds like Good News... but there is still so much that hangs on the particular Reviewer in each case!

I really appreciated the post of Dr. Aditi Sheth on this topic a few years ago. Dr. Sheth's post is focused on pharma submissions, but the challenges are the same for us in the device world... and I believe all the issues she pointed out are ever-so-much-more-so today!


Be sure your team is ready to work to get the Most for your User Fee.... and smooth sailing for your submission!








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