IRADIMED Receives FDA Warning Letter - Quick Facts

(RTTNews) - IRADIMED CORP. (IRMD) announced that it received a warning letter from the U.S. Food and Drug Administration relating to an inspection of facility that took place in April 2014.

The warning letter, among other things, states that a new submission is required under Section 510(k) of the Food, Drug and Cosmetic Act for the company's IV infusion pump systems due to periodic updates of the software on previously cleared infusion pumps, the mRidium 3860 and mRidium 3850.

The warning letter states that such updates are "significant" modifications that could significantly affect the safety or effectiveness of the devices and therefore the products being sold by the company are "adulterated" and "misbranded" under the FDCA.

The warning letter also indicates that the mRidium 3860+ infusion pump requires separate FDA clearance from the mRidium 3860 and mRidium 3850.

The warning letter requests that the company immediately cease activities that result in the misbranding or adulteration of the mRidium 3860 MRI infusion pump, mRidium 3850 MRI infusion pump, and the mRidium 3860+ MRI infusion pump, such as the commercial distribution of the device.

IRADIMED said it is in the process of preparing a response to the warning letter and intends to work expeditiously to address the issues raised by the FDA.