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U.S. Department of Health and Human Services

Combination Products

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Meetings, Conferences, & Workshops

Text Version of PowerPoint Presentation by Terry Sweeney, Philips Medical Systems

Slide 1 - NEMA’s Comments for the Office of Combination Products Public Hearing

Slide 2 - Question 2

Safety and Effectiveness should be considered on a component basis

  • Imaging Contrast Agent
  • Imaging Device (Magnetic Resonance, Ultrasound, etc.)

Effectiveness should be delegated to the component with the Primary Function

  • Imaging system creates the image, Imaging system has the primary function.

Slide 3 - Question 2 - cont.

Center with appropriate expertise in the primary function should lead the review of effectiveness

  • CDRH should be lead reviewer for effectiveness of imaging systems using contrast agents that have been approved for safety by CDER.

Slide 3 - Question 3

Use review process appropriate to the component

  • Contrast Agent: Drug safety: CDER
    • New drug
    • Revised dosing
  • Imaging Device: Imaging Efficacy: CDRH
    • New indication
    • Expanded indication

Slide 4 - Question 4

Use Application appropriate for the component

  • Contrast Agent: Drug Application processes
    • NDA, aNDA
  • Imaging Device: Device application processes
    • 510(k), PMA

Slide 5 - Question 5

Use Quality System appropriate for the component

  • Contrast Agent: cGMP
  • Imaging Device: QSR

Slide 6 - Question 6

Use adverse event reporting system appropriate for the cited component

  • Contrast Agent: Adverse Experience Reports
  • Imaging Device: Medical Device Reports (MDR)

Slide 8 - Question 7

Separate cross labeling requirements:

  • Use Least Burdensome provisions to set appropriate regulatory controls
  • Intended Use statements may be distinct based upon safety risk:
    • Contra-indications may be applied to only one OR both components
    • Cross-reference high-risk issues
    • De-couple component-specific issues (i.e. effectiveness)

Slide 9 - Question 7 - cont.

  • Allow manufacturers of each component of a combination product to modify labeling in line with a high degree of patient protection
    • Pharmacology: Agent manufacturer
    • Imaging effectiveness: Device manufacturer
  • Allow Center with expertise in each component to review labeling for that component
    • Contrast Agent: CDER
    • Imaging Device: CDRH