FDA

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FDAs Critical Path to New Medical Product
Development

Opportunities from the Center for Devices and
Radiological Health Larry Kessler, Sc.D.,
Director Office of Science and Engineering
Laboratories, CDRH
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Outline

• Devices are different and varied
• Our vision and the critical path
• Device opportunities
• Directions for the future
• Evaluative tools The techniques methodologies
  needed to evaluate the safety, efficacy quality
  of medical products as they move down the path

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Examples of some of these medical devices
Heart Valve
Patient Examination Table
Blood Pressure Cuff
Contact Lens
Stethoscope
Infusion pump
Pacemaker
Hip Implant
Biopsy Device
Test Strips
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CDRHs Vision
Ensuring the Health of the Public Throughout the
Total Product Life Cycle -- It's Everybody's
Business

• Underlying Assumptions
• Covering products from concept to obsolescence
• Connected global public health community
• Stakeholders are our partners
• Science fuels the regulatory engine
• Meeting all statutory responsibilities
• Meeting our own standards for quality

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Areas that FDAs Critical Path Can Impact
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Imaging and the ROC curve

• Digital mammography
• Initial studies ignored reader variability
• True clinical trials too big
• Multiple-reader multiple-case ROC analysis
  developed by FDA (and others)
• Studies became accessible
• Products on the market!

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Imaging of Peripheral Vasculature

• Drug eluting stents proven for coronary
• Will standard imaging of lower extremities
  provide adequate data?
• Requires independent study to establish data and
  methods for later trials

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Ablative Therapies

• Ablative therapies for atrial fibrillation
• AF commonly diagnosed
• Problem in demonstrating true patient benefit
• Requires large patient series
• Requires agreement on endpoints and data analysis
  from co-sponsored study

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Cataractous Crystalline Lens

• Intraocular lens (IOLs)
• Successful but has limits
• Single focal length unlike human lens
• Critical path issues assessment of
• Optical quality
• Material properties
• Biocompatibility

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Genomic and proteomic devices

• Microarray expression discovery phase
• For multiple expression profile an algorithm is
  needed for interpretation
• Current algorithms are learning
• FDA products require reliability and consistency
• No standards yet for these algorithms

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Future Directions

• Identify key problems in devices
• Prioritize scientific efforts
• Pursue collaborations
• Within FDA
• With NIH (e.g., NIBIB, NCI)
• With industry