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Zdrowie i gospodarka · 24.03.1999

Laser Products; Proposed Amendment to Performance Standard

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. This action is being taken under the Federal Food, Drug, and Cosmetic Act as amended by Radiation Control for Health and Safety Act of 1968.

Source: Federal Register — Food and Drug AdministrationOpen original release →