What is the Pioneering Role in Laser Safety Regulations

This paper discusses FDA’s role in developing product standards and other activities such as informative brochures for physicians and public information for consumers. 150mW blue Laser Pointer 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.
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.
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.
Now decades later, the FDA programs have implemented reporting requirements for the manufacturers and safety standards for equipment. This powerful laser pointer 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.