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.
Recommended Actions
- Determine if proposed change requires device submission only or both device and drug submissions
- Engage in early communication with FDA to:
- Obtain feedback on required preclinical/clinical data
- Identify critical development issues
- Establish intercenter review team
- Design appropriate clinical trials considering:
- Drug class characteristics and differences
- Device settings and performance
- Safety monitoring requirements
- Prepare comprehensive submission including:
- Clinical trial data
- Preclinical test results
- Software/technology validation
- Proposed labeling changes
- Implement post-approval monitoring of:
- Drug labeling changes
- Safety reporting
- Required postmarket surveillance
- 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
- Early communication with FDA recommended
- Intercenter review team coordination needed
- Primary mode of action determines lead FDA center
- Device changes consistent with drug labeling may only need device submission
- Drug changes may require both drug and device submissions
Relevant Guidances
- Content of Premarket Submissions for Device Software Functions
- Benefit-Risk Determinations for Medical Device Premarket Review
- Postmarket Surveillance Studies Requirements for Medical Devices Under Section 522
- Requests for Feedback and Meetings for Medical Device Submissions: The Q-Submission Program
Related references and norms
- 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
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