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GUIDANCE DOCUMENT

New Contrast Imaging Indication Considerations for Devices and Approved Drug and Biological Products Guidance for Industry December 2009

Final
Docket Number:
FDA-2008-D-0525
Issued by:
Guidance Issuing Office
Office of Combination Products
Center for Drug Evaluation and Research
Center for Devices and Radiological Health

FDA intends this guidance to assist developers of medical imaging devices and imaging drug/biological products (hereinafter more generally referred to as drugs or drug products) that provide image contrast enhancement in determining: 

  • When the imaging device developer may add certain new imaging contrast indications to its device for use with already approved imaging drugs without a need for a modification of the drug labeling;  
  • When the imaging drug developer may add certain new imaging contrast indications to its drug for use with already approved imaging devices without a need for a modification of the device labeling, and 
  • What type of marketing submission(s) the imaging drug or imaging device developer should submit to FDA to request approval/clearance to add a new imaging contrast indication.

Submit Comments

You can submit online or written comments on any guidance at any time (see 21 CFR 10.115(g)(5))

If unable to submit comments online, please mail written comments to:

Dockets Management
Food and Drug Administration
5630 Fishers Lane, Rm 1061
Rockville, MD 20852

All written comments should be identified with this document's docket number: FDA-2008-D-0525.