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Combination Products

Combination Products. NEMA’s Comments for the Office of Combination Products Public Hearing. Terry Sweeney, Philips Medical Systems. Question 2. Safety and Effectiveness should be considered on a component basis Imaging Contrast Agent Imaging Device (Magnetic Resonance, Ultrasound, etc.)

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Combination Products

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  1. Combination Products NEMA’s Comments for the Office of Combination Products Public Hearing Terry Sweeney, Philips Medical Systems

  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.

  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.

  4. 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

  5. Question 4 • Use Application appropriate for the component • Contrast Agent: Drug Application processes • NDA, aNDA • Imaging Device: Device application processes • 510(k), PMA

  6. Question 5 • Use Quality System appropriate for the component • Contrast Agent: cGMP • Imaging Device: QSR

  7. Question 6 • Use adverse event reporting system appropriate for the cited component • Contrast Agent: Adverse Experience Reports • Imaging Device: Medical Device Reports (MDR)

  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)

  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

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