FDA to Amend Standards for Laser Products

The Food and Drug Administration (FDA) is proposing to amend the performance standard for laser products to achieve harmonization between the current standard and the International Electrotechnical Commission (IEC) standard for laser products and medical laser products.

FDA is proposing additional changes that reflect FDA's understanding of how photobiological and behavioral factors, such as involuntary eye and body motion, affect the risk of injury from exposure. In addition, FDA is clarifying the requirement that manufacturers provide certain information to servicers. Generally, the proposed amendments will reduce the regulatory burden on affected manufacturers and improve the effectiveness of FDA's regulation of laser products.

Submit written comments by June 22, 1999, to the Dockets Management Branch (HFA-305), Food and Drug Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852.

For more information, contact Jerome E. Dennis, Center for Devices and Radiological Health (HFZ-342), Food and Drug Administration, 2094 Oak Grove Rd., Rockville, MD 20850; Tel: 301-594-4654, ext. 135.