The August 2014 warning letter chided Winter Springs, Fla.-based Iradimed for its complaint handling and ordered it to seek a new 510(k) clearance for software upgrades to one of the pumps, the mRidium 3860+, ordering the company to pull the device from the market. Iradimed won a new clearance for mRidium 3860+ in December 2016.
Yesterday the company said the FDA sent a letter saying all issues flagged in the 2014 warning letter had been resolved.
“Based on our evaluation, it appears that you have addressed the violation(s) contained in this warning letter. Future inspections and regulatory activities will further assess the adequacy and sustainability of these corrections,” according to the Oct. 2 missive from the FDA.
“The resolution of the warning letter is the result of countless hours of work performed by everyone at Iradimed. We are thankful for these efforts and the collective commitment to continuously improve our quality management system,” president & CEO Leslie McDonnell said in prepared remarks.
IRMD shares closed down -1.6% yesterday at $22.01 apiece.