FDA Issues Final Guidance on New Contrast Indications for Imaging Devices

By Alan M. Kirschenbaum –

On January 5, 2010, FDA released a “Guidance for Industry on New Contrast Indication Considerations for Device and Approved Drug and Biological Products.”  The primary purpose of the Guidance is to establish a process that allows imaging device manufacturers to obtain approval of new indications for use of a device with an already marketed contrast or radiopharmaceutical imaging drug (a “new contrast indication”), where the drug is not labeled for that indication.  FDA’s publication of the Guidance fulfills one of the Agency’s performance commitments under the Medical Device User Fee Amendments of 2007.  A draft version of this guidance was issued in September 2008, and FDA held a stakeholder meeting on the draft guidance in August 2009. 

Under the Guidance, if a new imaging device modification involves the use of an approved imaging drug in a manner consistent with the latter’s approved labeling, a submission from the device sponsor alone will be sufficient in most cases, without need for a change in the drug labeling.  Conversely, if a new imaging device modification requires a use of the approved imaging drug that is not consistent with the drug’s approved labeling, submissions will be required from both the drug and device sponsors to ensure consistent labeling – a situation that precludes a device manufacturer from implementing a modification unilaterally.  The final guidance provides a number of examples illustrating when a device submission alone would, or would not, be sufficient to support a new contrast indication for the device.  It appears from the examples that FDA will be restrictive in permitting new contrast indications for imaging devices without corresponding changes in the drug labeling.  Moreover, the Guidance requires device manufacturers who seek a new contrast indication modification to submit clinical study support similar to what would be required in an NDA supplement.  In light of these barriers, the Guidance is most likely to facilitate new device modifications for use with contrast only where the drug is used consistent with the indications, dosage, and rate and route of administration in the already approved drug labeling and where the new use does not raise new questions of safety and efficacy.