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 2001 micronucleus studies 2003 epidemiology studies 2004 Scientific meeting

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

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

Laser Products Harmonizing FDA requirements w/IEC Standard ( and ) July 2001 guidance document Conditions for use of IEC Additional FDA requirements FDA proposal on hold

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

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

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

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

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

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

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

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”