TEPRSSC Meeting CDRH Update

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TEPRSSC Meeting CDRH Update

• Lillian Gill
• October 1, 2003

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Current Issues

• Wireless telephones
• Laser standard
• CT safety
• Future direction of program

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Wireless Telephones

• Cooperative Research and Development Agreement
  (CRADA)
• CTIA and FDA
• Funds health effects research
• 2001 micronucleus studies
• 2003 epidemiology studies
• 2004 Scientific meeting

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Wireless Telephones

• Natl Toxicology Program
• Large animal study
• Toxicology and carcinogenicity of radio frequency
  radiation (RFR)
• CDRH Research
• Enzymes prompted by RF

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Wireless Telephones

• Collaboration w/ other Agencies
• Radio Frequency Inter-Agency
• Work Group (RF-IWG)
• Forum for health/regulatory issues

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Laser Products

• Harmonizing FDA requirements w/IEC Standard
  (960825-1 and 60601-2-22)
• July 2001 guidance document
• Conditions for use of IEC
• Additional FDA requirements
• FDA proposal on hold

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Computed Tomography

• Reduction of CT radiation dose 50
• Display and recording of dose
• Exposure based on patient
• Limiting field to reduce over-beaming

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Computed Tomography

• Stakeholder interaction
• 5/02 Natl Conf. on Radiation Control
• 12/02 Radiological Device Panel
• 2/03 Diag. Imaging Conf. on New
• Modalities and Radiation Safety
• CT Dosimetry Task Group of AAPM

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Computed Tomography

• Other FDA approaches
• Recognition of the IEC CT standard
• Voluntary declaration of conformity in PMAs
• Develop manufacturer and review guidance

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Future Directions

• Definition of roles/responsibilities
• Assessment of CDRH current/future activities
• Redirection of focus to medical ionizing
• Mandatory vs. consensus standards

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Future Directions

• Roles and responsibilities
• Assess quality
• Guidance, standards, product quality
• Acquire and manage data
• Educate and inform
• Assess emerging technology

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Future Directions

• Medical ionizing
• Accelerators, CT, Fluoro, dental, mammography
• Medical non-ionizing
• PRK lasers, MRI, ultrasound, sunlamps
• Non-medical ionizing
• Cabinet x-ray, security screening, TV
• Non-medical/non-ionizing
• Cell phones, video display, microwave ovens

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Future Directions

• New uses and emerging technology
• New design and used of diagnostic x-ray equipment
• New spiral scanning technology
• Transition from analog to digital
• Complex fluoro, digital imaging and CT x-ray
  systems
• Use of ultra sound and diagnostic lasers for
  diagnosis and treatment of cancers

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Future Directions

• Focus efforts on
• Quality standards for performance and use
• Understanding risks and benefits between dose
  levels and imaging performance
• Partner in educating manufacturers and users of
  dose intensive equipment technologies