FDA improves 510(k) clearance times!

MedTechDive reports: FDA improves 510(k) turnaround times, but PMA waits hit record high

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!