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    FDA Laser Notice 50

    Prepare for Laser Notice 56: The Future of Laser Compliance

    September 12, 2024
    Safety

    On June 7, 2023, the U.S. Food and Drug Administration (FDA) announced the upcoming withdrawal of Laser Notice 50, which will officially take place on December 31, 2024. This regulatory change affects laser product manufacturers who rely on Laser Notice 50 for compliance with specific standards.

    What Is Laser Notice 50?

    Laser Notice 50, first issued in June 2007, provided manufacturers the option to use certain sections of the IEC 60825-1:2007 (Ed.2) standard in place of similar requirements in the 21 CFR 1040 (the U.S. FDA’s standard for laser products). The notice helped manufacturers align their products with international standards, making it easier to comply with both U.S. and global regulations.

    Why Is Laser Notice 50 Being Withdrawn?

    The FDA is withdrawing Laser Notice 50 to ensure all laser products adhere to the most up-to-date safety regulations. Since the issuance of Laser Notice 50, newer standards and regulations have been developed that more accurately reflect the advancements in laser technology and safety. By moving away from older standards like IEC 60825-1:2007, the FDA aims to improve user protection from laser hazards.

    What Are the Next Steps for Manufacturers?

    Laser product manufacturers who currently use Laser Notice 50 will have to transition their products to comply with either:

    • Laser Notice 56, or
    • The original 21 CFR 1040 standard.

    Manufacturers must make this transition by December 31, 2024, after which Laser Notice 50 will no longer be applicable. Non-compliance after this date could result in penalties or restrictions on product sales within the U.S. market.

    Laser Notice 56 vs. 21 CFR 1040

    • Laser Notice 56: This newer notice offers updated guidelines that better align with IEC 60825-1:2014 (Ed.3), which includes modern laser safety protocols. Manufacturers who wish to continue aligning with international standards may find this notice useful for ensuring consistency across markets.
    • 21 CFR 1040: This is the original U.S. standard for laser products, and it remains a key compliance pathway. If manufacturers opt not to use Laser Notice 56, they will need to ensure that their products meet the requirements of 21 CFR 1040 in full.

    Impact on Manufacturers

    The withdrawal of Laser Notice 50 means that laser product manufacturers must review their current compliance strategies. Those using IEC 60825-1:2007 as permitted by Laser Notice 50 will need to evaluate the new requirements and determine the best transition pathway for their products. The December 31, 2024, deadline gives manufacturers some time. However, they should start the transition as soon as possible to avoid disruptions.

    360Compliance’s Role

    360Compliance has distributed this bulletin to inform its clients about the changes, specifically targeting those with products that fall under the relevant Category Control Numbers (CCN). Clients affected by the withdrawal of Laser Notice 50 should carefully review the bulletin. They must also consider the necessary steps to transition to the newer standards or 21 CFR 1040.

    Ensure Your Laser Products Stay Compliant – Don’t Wait Until the Deadline!

    The December 31, 2024, deadline for transitioning from Laser Notice 50 is approaching fast. Start your compliance process now to avoid costly delays, fines, or product restrictions in the U.S. market.

    What’s Your Next Step?

    • Review your compliance path: Are you transitioning to Laser Notice 56 or fully adopting 21 CFR 1040?
    • Get ahead of the game: Begin your product testing and certification early to secure your place in the market.

    360Compliance can help you navigate the FDA compliance process, ensuring your laser products meet all necessary requirements. Our experts are ready to guide you through every step, from reviewing your current compliance status to assisting with testing and certification.

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