FDA's New Laser Safety Standards: What You Need to Know

On June 7, 2023, the U.S. Food and Drug Administration (FDA) Center for Devices and Radiological Health (CDRH) issued a significant notice regarding the forthcoming withdrawal of Laser Notice No. 50 by the conclusion of 2024—precisely on December 31, 2024. This bulletin outlined significant regulatory changes that would impact manufacturers and distributors of laser products. 

Laser Notice No. 50 had been a regulatory guideline or standard that manufacturers of laser products were required to adhere to. This notice provided specific requirements and safety guidelines related to laser products in order to ensure consumer safety and product quality. 

The replacement for Laser Notice No. 50 is Laser Notice No. 56, which is based on: IEC 60825-1 Ed. 3 and IEC 60601-2-22 Ed 3.1. These are international standards that pertain to the safety of laser products and medical electrical equipment, respectively. Manufacturers of laser products are now required to transition their products to conform to the guidelines outlined in Laser Notice No. 56, ensuring that their products meet the safety and quality standards specified in IEC 60825-1 Ed. 3 and IEC 60601-2-22 Ed 3.1.

Manufacturers are advised that these changes may require various actions, including updating product files, modifying accession numbers, revising labeling, updating documentation, and potentially re-testing their products to ensure compliance with the new standards.

Importantly, the bulletin emphasizes that there will be no "grandfathering" of products under the previous Laser Notice No. 50. This means that manufacturers cannot simply continue to market or distribute products that were compliant under the old guidelines; instead, they must ensure that their products conform to the updated Laser Notice No. 56 and the associated international standards.

Manufacturers are strongly advised to undertake necessary measures to align their laser products with these updated regulations, ensuring both consumer safety and adherence to quality standards. Contact us if you have any questions about how the change may affect your products.