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