FDA / CDRH Submissions

All laser products entering the USA must be registered with the FDA to legally enter the country

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, is in charge of enforcing the regulations. 21 CFR 1040.10 is the laser product regulation.

To enter the United States legally, a laser product must have an accession number, which must be quoted on the importer’s declaration. A laser product report must be submitted to the FDA in order to obtain the accession number. The FDA does not charge for receiving reports or issuing accession numbers.

The laser product report can be submitted by anyone. However, compiling the report is extremely time consuming, laborious, and confusing for those who are unaware of the requirements. Furthermore, unless you are familiar with the regulation, it is very likely that the report will contain inaccuracies that will cause an issue with the FDA.

Lasermet will compile and submit the report on your behalf to save you time and effort.

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.