FDA / CDRH RegistrationRegistration of Laser Products with the FDA (CDRH)

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

* 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’. To obtain the accession number a ‘laser product report’ must be submitted to the FDA. The FDA do not make any charge for receiving the report or issuing the accession number.

* Anyone can submit the ‘laser product report’. However, compilation of the report is extremely laborious, time consuming and confusing for those who are not used to it. 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 will compile and submit the report on your behalf. The accession number will be issued by the FDA some time later (usually within 1 month) and forwarded to you, the customer. However, once proof of delivery of the report to the FDA is obtained the product can be legally exported to the USA. Lasermet can obtain proof of delivery within 2 days of sending the report.

Laser Notice 50

In 2001 the FDA issued ‘Laser Notice 50’. This states that the FDA will accept classification and labelling to IEC 60825-1 as opposed to the classification and labelling 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). This enables manufacturers to use one classification and one set of labelling for their laser products, instead of two. Consequently, for non-US manufacturers, we normally register laser products under 21 CFR 1040.10 in conjunction with Laser Notice 50, unless there is a specific reason for not doing so.

Worldwide Service

Whilst carrying out this service, communication between our consultants and the customer is carried out primarily by email with some telephone contact if necessary. We do not need to see the product. Consequently we are able to carry out this service for manufacturers throughout the world without being hindered by distance.

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