FDA Proposed Rule to Amend the Laser Products Performance Standard
On Monday, June 24, 2013, the Food and Drug Administration (FDA) issued a proposed rule to amend the performance standard for laser products. This will achieve closer harmonization between the current standard and the International Electrotechnical Commission (IEC) standards for laser products and medical laser products, to reduce the economic burden on affected manufacturers, and to improve the effectiveness of FDA’s regulation of laser products. In addition, this amendment to the performance standard addresses laser technology advancements and concomitant risks and benefits in order to more effectively protect and promote the public health. Currently, firms producing laser products for sale within the United States and abroad have to follow both IEC and FDA standards. Aligning such standards would mean that firms currently complying with two different sets of standards would generally need to comply with only one, except where the standards differ (e.g., collateral radiation limit).
The FDA will take comments on the proposed rule within 90 days of publication in the Federal Register.
For more information:
Federal Register Notice
FDA Radiation-Emitting Products Web site
Thank you for your support,
Food and Drug Administration
Center for Devices and Radiological Health