The company has replied to each of the detailed objections in the attached Warning Letter and hopefully the FDA is still working on resolving these issues. Biggest issue IMO would seem to be not obtaining the IDE even before the clinical trial which was not clear and apparent to the company at any stage even to date. The consultant is speaking and hopefully can bring the FDA exceptions to a resolution? Please review the attached for better understanding!
UEEC IMO never intentionally or un-intentionally attempted to circumvent FDA regulations!

https://www.fda.gov/inspections-compliance-en...7-03242025

$5-$10+