A Brief Overview of Laser Regulations and Compliance
17 May 2019
Does your company manufacture or import products that contain lasers? If so, you must comply with the regulations under the Federal Food, Drug and Cosmetic Act (FFDCA), Chapter V, Subchapter C – Electronic Product Radiation Control, that applies to manufacturers of Laser products. Therefore, you need an accession number from the FDA.
In the USA, laser safety is dealt with by regulations which are part of federal law (as opposed to Europe where manufacturers self certify to various product standards). CDRH, which is part of FDA, has the task of enforcing the regulations. The laser product regulation is known as 21 CFR 1040.10.
* To legally enter the USA a laser product must have an accession number which needs to be quoted on the ‘importers declaration’ (click here to download). In other words, to obtain the accession number, a ‘laser product report’ must be submitted to the FDA.
* Anyone can submit the ‘laser product report’. However, compilation of the report is time consuming and confusing for those who are not used to it. In addition, unless you are familiar with the regulation it is likely that the report will contain inaccuracies which can cause a problem with the FDA.
*RT Technologies will compile and submit the report on your behalf. After that, the accession number will be issued by the FDA. This happens some time later (usually within 1 month) and forwarded to you, the customer. Have a professional tackle this for you. Moreover, we will save you time, money, and headaches.
Laser Notice 50
In 2001 the FDA issued ‘Laser Notice 50‘. The FDA will accept classification and labeling to IEC 60825-1 as opposed to the classification and labeling detailed in 21 CFR 1040.10 which is different. (IEC 60825-1:2001 is the international standard dealing with the optical safety of laser products and is identical to EN 60825-1:2001). Manufacturers can use one classification and one set of labeling for their laser products, instead of two.
In conclusion, if this seems like a daunting task, leave it to us. RT Technologies has years of experience with FDA Regulations and our CLSO can make it seemingly painless. Please feel free to contact us with any questions you may have. We look forward to working with you!