Laser safety is addressed by regulations that are part of federal law in the United States (as opposed to Europe, where manufacturers self-certify to various product standards). The CDRH, which is part of the FDA (Food and Drugs Administration), has the task of enforcing the regulations. The laser product regulation is known as 21 CFR 1040.10.
The Center for Devices and Radiological Health (CDRH) is the agency responsible for ensuring the safety and effectiveness of medical devices and regulating radiation-emitting electronic products, both medical and non-medical.
All laser products manufactured in the USA must be registered with the FDA for legal sale and use
Any laser products (or systems incorporating lasers) must have an accession number which needs to be quoted on product records – sales and regulatory documents – assuring your customers that the laser product is certified for U.S. sale and use. To obtain the accession number a laser product report must be submitted to the FDA. This is the duty of the laser manufacturer.
Any representative from the manufacturer can submit the laser product report. However, compilation of the report is extremely laborious, time consuming and confusing for those who are not informed of the requirements. In addition, unless you are familiar with the regulation it is quite likely that the report will contain inaccuracies which may cause a problem with the FDA.
In order to save you time and effort Lasermet offer FDA submission services to compile and submit the report on your behalf.
Laser Notice 56
The FDA issued Laser Notice 56 in 2019. This states that the FDA will accept IEC 60825-1 classification and labeling rather than the classification and labeling detailed in 21 CFR 1040.10, which differs significantly.
The international standard dealing with the optical safety of laser products, IEC 60825-1, is identical to EN 60825-1. This allows manufacturers to use a single classification and labeling set for their laser products rather than two. As a result, unless there is a specific reason not to, we normally register laser products for non-US manufacturers under 21 CFR 1040.10 in conjunction with Laser Notice 56.
Worldwide Service
Communication between our consultants and the customer during this service is primarily via email, with some phone contact as needed. To complete FDA submissions, no sample product is required. As a result, we can provide this service to manufacturers all over the world without being constrained by geography.
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