FDA's Pioneering Role in Laser Safety Regulations

S.L.B. Kent and J.E. Dennis (Food and Drug Administration)

The US Food and Drug Administration (FDA), Center for Devices and Radiological Health (CDRH) is one of the most important contributors in expertise in radiation emitted from electronic products. The Agency pioneered measurement methodologies and safety evaluations of emissions from the products and used the early science to make risk estimates to public health. In the 1960s when high-powered lasers became a source used for entertainment and artistic lighting at concerts, including outdoor events, there arose a serious potential for laser injury. In the early years before the regulatory program evolved and no national or international controls existed, FDA worked with state public health/radiation agencies, local fire departments, universities and industry to evaluate the public health impacts of these products. This laser safety concern launched legislative and regulatory events. Now decades later, the FDA programs have implemented reporting requirements for the manufacturers and safety standards for equipment. This has resulted in greatly expanded controls of domestic and imported electronic products as products with significant hazard were removed from the market. Methods have evolved such as product recalls, embargoes, import detentions and alerts, a product review process, and field inspections and investigations. Coordination with state counterparts is also a significant part of the current controls. The Agency has taken steps to harmonize US regulations with the IEC (International Electrotechnical Commission) standards for Safety of Laser Products for a consistent international approach. This paper discusses FDA's role in developing product standards and other activities such as informative brochures for physicians and public information for consumers. It traces the legislative history of the Radiation Control for Health and Safety Act of 1968 and subsequent development of the regulatory program including highlights major milestones.

Return to Session list.