MITA: FDA resumes clearing contrast devices

Dec 21, 2010

The U.S. Food and Drug Administration (FDA) has eased internal rules that had prevented the agency for much of 2010 from clearing medical imaging products designed to work with contrast agents, according to industry trade group Medical Imaging & Technology Alliance.

Rosslyn, VA-based MITA said on December 22 that the FDA had notified the group that it would resume clearing imaging products "that include contrast agent functionalities and/or indications in their labeling that require contrast agents."

After the FDA issued a guidance on contrast agents in December 2009, "administrative decisions at the agency" prevented the clearance of imaging products that might use contrast media, MITA said. As a result, products and functionalities that might have been cleared by the FDA in the past struggled to gain clearance, and many vendors responded by "defeaturing" or removing functionality from their products.

MITA said that the FDA's decision this week will restart the clearance process for many of these devices, and allow previously cleared indications with contrast agents to be included in device labeling. MITA said it was looking forward to working with the FDA to find a permanent solution t the issue.

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