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U.S. Department of Health and Human Services

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Imaging Devices with Contrast Agents or Radiopharmaceuticals

FY 2009 MDUFA Performance Report Table of Contents

FDA published the draft guidance, “Guidance for Industry: New Contrast Imaging Indication Considerations for Devices and Approved Drug and Biological Products,” as called for by the HHS Commitment Letter during FY 2008. The Docket comment period closed in January 2009. In August 2009, FDA hosted an imaging stakeholder meeting to receive further comments on the draft guidance. The draft guidance is available at: Guidance for Industry: New Contrast Imaging Indication Considerations for Devices and Approved Drug and Biological Products.  

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