The FDA has decided to resume clearing imaging agents that include contrast agent functionalities or indications in their labeling that require contrast agents.
The agency's announcement, made Dec. 22, 2010, reverses its clearance process that was in place for most of 2010. During 2010, the FDA adhered to contrast agent guidance document that prevented imaging products that may be used with contrast agents from being cleared by the agency. Consequently, previously cleared products no longer satisfied the FDA’s requirements, which led manufacturers to “de-feature” or remove functionalities from previously cleared agents.
The FDA’s decision re-starts the clearance process for contrast agents and allows previously cleared indications with these agents to be included in device labeling.
Imaging stakeholders welcomed the new policy. “We now look forward to finding a permanent solution and also to working with the agency in improving the guidance to fully recognize the central role of imaging in medicine and the broad use of contrast agents with imaging devices,” stated Dave Fisher, executive director of the Medical Imaging & Technology Alliance (MITA).