{"id":4544,"date":"2019-11-29T00:00:30","date_gmt":"2019-11-29T00:00:30","guid":{"rendered":"https:\/\/www.lasermetusa.com\/laser-safety-services\/fda-cdrh-registration\/"},"modified":"2025-07-18T05:33:45","modified_gmt":"2025-07-18T05:33:45","slug":"fda-cdrh-registration","status":"publish","type":"page","link":"https:\/\/www.lasermet.com\/us\/laser-safety-services\/fda-cdrh-registration\/","title":{"rendered":"FDA \/ CDRH Registration"},"content":{"rendered":"\n
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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.<\/p>\n\n\n\n

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. <\/p>\n\n\n\n

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All laser products manufactured in the USA must be registered with the FDA for legal sale and use<\/strong><\/p><\/blockquote><\/figure>\n\n\n\n

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Any laser products (or systems incorporating lasers) must have an accession number which needs to be quoted on product records \u2013 sales and regulatory documents \u2013 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.<\/p>\n\n\n\n

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.<\/p>\n\n\n\n

In order to save you time and effort Lasermet offer FDA submission services to compile and submit the report on your behalf.<\/p>\n\n\n\n

Broadly there are three main types of submissions to the FDA\/ CDRH.<\/p>\n\n\n\n

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