In September 2014, the company received a warning letter from the U.S. Food and Drug Administration requesting that it cease commercial distribution of its infusion pumps and submit a 510(k) application. IRADIMED submitted the 510(k) application on Nov. 24, and it was formally accepted for review by the FDA on Dec. 12. The company stated it will continue to work with the FDA as it conducts its review of the 510(k) submission.
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