Fixing a glitch in its clearance process, FDA last week moved to  to resume clearing imaging products that include contrast agent functionalities or indications in its labeling that require contrast agents. The Medical Imaging & Technology Alliance (MITA) welcomed the decision.

According to MITA, for much of 2010, imaging manufacturers struggled to navigate the FDA clearance process as administrative decisions at the agency prevented imaging products that may be used with contrast agents from being cleared by the Agency.

"The decisions meant that many products and functionalities that have been cleared by the FDA in recent years could no longer pass muster with the agency," says MITA. "As a result, companies were 'defeaturing' or removing key functionalities from their devices that had previously been cleared."

MITA says FDA’s decision will effectively restart the clearance process for these imaging products and allow previously cleared indications with contrast agents to be included in device labeling.

“Imaging manufacturers appreciate the agency’s efforts to constructively work with manufacturers and the medical community to find an interim solution to the challenges brought on by the agency’s interpretation of the contrast agent guidance issued last December,” said Dave Fisher, executive director of MITA. He says MITA wants to help FDA improve the guidance to fully recognize the central role of imaging in medicine and the broad use of contrast agents with imaging devices.