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TEPRSSC Meeting CDRH Update

TEPRSSC Meeting CDRH Update. Lillian Gill October 1, 2003. Current Issues. Wireless telephones Laser standard CT safety Future direction of program. Wireless Telephones. Cooperative Research and Development Agreement (CRADA) CTIA and FDA Funds health effects research

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TEPRSSC Meeting CDRH Update

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  1. TEPRSSC Meeting CDRH Update Lillian Gill October 1, 2003

  2. Current Issues • Wireless telephones • Laser standard • CT safety • Future direction of program

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

  4. Wireless Telephones • Nat’l Toxicology Program • Large animal study • Toxicology and carcinogenicity of radio frequency radiation (RFR) • CDRH Research • Enzymes prompted by RF

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

  6. 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

  7. Computed Tomography • Reduction of CT radiation dose ~50% • Display and recording of dose • Exposure based on patient • Limiting field to reduce “over-beaming”

  8. Computed Tomography • Stakeholder interaction • 5/02 Nat’l 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

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

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

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

  12. 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

  13. 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

  14. 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”

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