CorMedix Inc. (“CorMedix”) (NYSE Amex: CRMD), a pharmaceutical company focused on developing and commercializing therapeutic products for the prevention and treatment of cardiorenal disease, today announced it has received a communication from the U.S. Food and Drug Administration (“FDA”) regarding its recent regulatory submission for Neutrolin ®.
CorMedix has filed a Request For Designation (“RFD”) for Neutrolin ® to be classified as a device and assigned to the Center For Devices and Radiological Health as lead reviewer. This is in response to a communication from the FDA following CorMedix’s Investigational Device Exemption (“IDE”) amendment submission. The RFD enables the FDA to determine the product type and appropriate lead center. If the FDA has not issued a designation letter within 60 calendar days of the filing of the RFD, CorMedix’s recommendation will become the designated classification and assignment. Pending device designation and IDE approval, CorMedix expects to begin its planned Neutrolin ® clinical study in the second half of 2011.
Additionally, CorMedix expects to complete the initial submission of the Neutrolin Design Dossier to the European notified body by the end of the second quarter 2011 and the company’s guidance with respect to timing remains consistent on European launch in the first half of 2012, pending CE mark approval.
About CE markCE marking ensures the free movement within the European market of products that conform to the requirements of EU legislation (e.g. safety, health and environmental protection and is a key indicator of a product’s compliance with legislation. The CE marking is affixed by manufacturers to their products. By placing CE marking on a product, manufacturers declare on their sole responsibility that the products comply with all the legal requirements in force in Europe. It is the manufacturer's responsibility to verify that the goods they are selling comply with all relevant legislation or – if necessary – to have it examined by a notified conformity assessment body for that purpose.