FDA Issues Contrast Imaging Draft Guidance; Implements Umbrella Approach to Imaging Device Labeling

FDA’s Office of Combination Products (“OCP”) recently released a draft guidance entitled “New Contrast Imaging Indication Considerations for Devices and Approved Drug and Biological Products.”  The draft guidance permits diagnostic imaging device makers to expand labeling for use with a contrast agent or radiopharmaceutical even if there is no change in the labeling for the imaging drug.  This document was released as part of an effort to “ensure timely and effective review” of imaging devices used with contrast agents or radiopharmaceuticals, as mandated in the 2007 Medical Device User Fee Amendments commitment letter.

OCP’s draft guidance is addressed to the problem of how to bring to market an imaging device intended to take advantage of a new indication for a previously approved imaging drug, when the drug manufacturer is not inclined to seek a change in its own labeling or otherwise cooperate in the clearance or approval process for the device.

The draft guidance is the first ever to implement a so-called “umbrella” approach to the imaging device labeling as a potential resolution of the problem. It permits the new indication for the imaging drug to be added to the imaging device labeling even if the indication is not added to the drug labeling.

OCP has, however, included significant restrictions. First, the umbrella device labeling would likely be developed through the more burdensome PMA process rather than the 510(k) process.  Second, the sponsor would likely be required to conduct a clinical trial employing both the drug and device to support the new indication.  Finally, the new indication would have to be consistent with the drug labeling and could not require any change in the formulation, dose, rate and route of administration of the drug. If the latter type of changes were required, then the umbrella device labeling approach would not be permitted under this guidance.

Despite these restrictions, OCP’s draft guidance represents a promising step forward toward resolution of the vexing issues created by innovation in devices that have an impact on the use of previously approved drugs.  This draft guidance, in the circumstances when it applies, should enable the imaging device manufacturer to promote a new indication for an imaging drug in conjunction with its device, even if the drug manufacturer does not seek a change in the drug labeling.

By Jeffrey K. Shapiro