FDA Laser Notice 50 Withdrawal for Laser Certifications

On June 7, 2023, the U.S. FDA issued a bulletin announcing that, by the end of 2024, Laser Notice 50 will be withdrawn. Laser Notice 50, issued in June 2007, is the Laser Notice that allows manufacturers to use portions of IEC 60825-1:2007 (Ed. 2) in lieu of similar requirements in the 21 CFR 1040.10 and 1040.11. Laser product manufacturers are required to certify that their laser products meet these requirements, and submit an appropriate report to the FDA, prior to introducing the product into U.S. commerce.

The reason for the Laser Notice 50 withdrawal is that there is a newer version of the IEC standard – IEC 60825-1:2014 (Ed. 3), and the use of the previous version from 2007 has become outdated. Laser Notice 56, issued in May 2019, describes how the FDA will allow manufacturers to use portions of the most recent IEC 60825-1:2014 in lieu of similar requirements in the 21 CFR 1040.10 and 1040.11. From May 2019 to December 2024, manufacturers may either use Laser Notice 50 (pointing to IEC 60825-1:2007) or Laser Notice 56 (pointing to IEC 60825-1:2014).

What is the impact?

Because of this Laser Notice 50 withdrawal, laser product manufacturers currently using Laser Notice 50 will need to transition to Laser Notice 56 by the end of 2024. Laser products manufactured in 2024, certified to the FDA requirements using Laser Notice 50, and labeled with a 2024 manufacturing date, are acceptable after 2024. However, the same laser product manufactured in 2025 and labeled with a 2025 manufacturing date cannot use Laser Notice 50 — they will need to use Laser Notice 56 or the 21 CFR 1040.10/1040.11 requirements.

The impact of this transition from Laser Notice 50 to 56 (and thus the transition from requirements in IEC 60825-1:2007 to IEC 60825-1:2014) on laser products can vary depending on the product type, configuration, and scenario. The impact may be as simple as an updated FDA/CDRH Certification Label pointing to the newer Laser Notice 56, or it could be more detailed since there are other changes in the IEC 60825-1 standard between the 2007 and 2014 versions. Regardless of the impact, the compliance post-Laser Notice 50 would need to be documented and submitted to the FDA through the appropriate report type (e.g., Supplemental report).

Also note that UL Certified products may use compliance with the FDA laser product safety requirements to address potential laser radiation hazards from the product. For those products that were UL Certified based on the use of Laser Notice 50, the UL Certification and UL Report may also need to be updated to address the transition to Laser Notice 56. Similar to the above, this impact may be as simple as describing an updated FDA/CDRH Certification Label in the UL Report pointing to the newer Laser Notice 56, or it could be more detailed since there are other changes in the IEC 60825-1 standard between the 2007 and 2014 versions.

How can UL Solutions help?

We can offer assistance to laser product manufacturers as they work to transition from Laser Notice 50 to Laser Notice 56 (or to 21 CFR 1040.10 and 1040.11). For manufacturers that need to update their FDA certifications as a result of these changes, we can assist manufacturers with any questions and we can assist with preparing the necessary reporting to send to the FDA.

Also, for manufacturers that need to update existing UL Certifications, we can assist in updating the necessary UL Reports to reflect the changes.

More information on UL Solutions optical radiation/laser services can be found here.

Please contact us with any questions or needs you may have on the Laser Notice 50 withdrawal.

Other related links

• Laser Notice 50 withdrawal announcement – Prepare to transition to Laser Notice No. 56 (govdelivery.com)
• Laser Notice 50 – Laser Products - Conformance with IEC 60825-1 and IEC 60601-2-22; (Laser Notice No. 50) | FDA
• Laser Notice 56 – Laser Products - Conformance with IEC 60825-1 Ed. 3 and IEC 60601-2-22 Ed. 3.1 (Laser Notice No. 56) - Guidance for Industry and Food and Drug Administration Staff (fda.gov)

About the author

Winn Henderson serves as UL Solutions principal engineer for optical radiation, which includes laser, LED/lamp and UV radiation product safety. He graduated from NC State University with a Bachelor of Science in electrical engineering and has been working in optical radiation–related product safety at UL Solutions since 1997. Winn actively participates on IEC TC76 and CTL ETF11.