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【 USA 】 FDA Laser Notice No. 50 Withdrawal

On June 7, 2023, the U.S. FDA made an announcement regarding the withdrawal for FDA Laser Notice No.50, set to take effect by the end of 2024.
Manufacturers currently utilizing FDA Laser Notice No.50 for their laser products are required to transition to FDA Laser Notice No.56 by the end of 2024.
The replacement notice, FDA Laser Notice No.56 aligns with standards outlined in IEC 60825 1 Ed. 3 and IEC 60601 2 22 Ed. 3.1.
After 2024, Laser products manufactured in 2024, certified to the FDA requirements using Laser Notice No.50, and labeled with a 2024 manufacturing date, are acceptable. However, the same laser products manufactured in 2025 and labeled with a 2025 manufacturing date cannot use Laser Notice No.50 they will need to use Laser Notice No. 56 or the 21 CFR 1040.10/1040.11 requirements instead.


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