Tag Archives: 21CFR1040
FAQ: FDA Laser Notice No. 50
FAQ: FDA Laser Notice No. 50 What you need to know about Laser Safety for United States and International markets What is FDA Laser Notice No. 50? Laser Notice No. 50 is an FDA guidance document that determines what components of IEC 60825 and IEC 60601-2-22 can be used to meet requirements found in 21CFR1040... Read More
Laser and Photonics Products Have Unique Safety Requirements
When it comes to development of products with an integrated laser or photonic technology (including fiber optics), it pays to be aware of product safety regulatory and compliance requirements from an early stage. Lasers and other photonics technologies create unique risks due to their highly concentrated light. Therefore, regulations exist at various levels: Local (U.S.)... Read More