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Adding Imaging Contrast Indications to Medical Devices Used with Approved Imaging Drugs

This guidance assists developers of medical imaging devices and imaging drug/biological products in determining when new imaging contrast indications can be added to devices for use with approved imaging drugs without drug labeling modification, and what type of marketing submission(s) should be submitted for approval/clearance. The guidance aims to promote timely and effective premarket review and consistent regulation/labeling for imaging drugs and devices.

  1. Determine if proposed change requires device submission only or both device and drug submissions
  2. Engage in early communication with FDA to:
    • Obtain feedback on required preclinical/clinical data
    • Identify critical development issues
    • Establish intercenter review team
  3. Design appropriate clinical trials considering:
    • Drug class characteristics and differences
    • Device settings and performance
    • Safety monitoring requirements
  4. Prepare comprehensive submission including:
    • Clinical trial data
    • Preclinical test results
    • Software/technology validation
    • Proposed labeling changes
  5. Implement post-approval monitoring of:
    • Drug labeling changes
    • Safety reporting
    • Required postmarket surveillance
  6. Maintain ongoing communication with FDA review team throughout development and review process

Key Considerations

Clinical testing

  • Clinical trials should be appropriately designed to use both imaging drug and device
  • Type and volume of data may vary based on indication, patient population, safety questions
  • Trial designs should address differences within drug/device classes as appropriate
  • Early studies should establish imaging drug dosing and device energy differences needed for labeling

Non-clinical testing

  • Preclinical test results should be provided
  • Device software or new technology validation when appropriate

Software

  • Software validation required for device modifications
  • Software changes that affect drug characteristics need additional review

Labeling

  • Device and drug labeling should be generally consistent
  • Labeling should reflect essential information establishing imaging contrast indication
  • Indication statements should include clinical study description, device characteristics/settings, drug dosing regimen, target organ

Safety

  • Safety profile of drug class should be considered in trial design
  • Monitoring of approved drug’s labeling and changes required post-approval
  • Postmarket surveillance may be required

Other considerations

  • 21 CFR Part 3: Definition of Primary Mode of Action of a Combination Product
  • 21 CFR 201.57: Labeling Requirements
  • 21 CFR 814.20: Premarket Approval Application Content
  • 21 CFR Part 803: Medical Device Reporting
  • 21 CFR Part 822: Postmarket Surveillance

Original guidance

  • Adding Imaging Contrast Indications to Medical Devices Used with Approved Imaging Drugs
  • HTML / PDF
  • Issue date: 2010-01-06
  • Last changed date: 2020-05-14
  • Status: FINAL
  • Official FDA topics: Medical Devices, Combination Products, Drugs, Biologics
  • ReguVirta summary file ID: a95a484490787fc390778b317b699b8f
This post is licensed under CC BY 4.0 by the author.