TEPRSSC Meeting CDRH Update

Lillian GillOctober 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 (960825-1 and 60601-2-22)

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”