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Introduction to US Federal Requirements

Introduction

The US Center for Devices and Radiological Health (CDRH), a division of the US FDA (Food and Drug Administration) is responsible for administering the regulations which apply to laser light emitting products.  These regulations can be found in CFR 21, Section I, subchapter J, parts 1002 to 1040.11.  Laser products are classified into categories depending on the level of hazard they present.  This hazard level is in turn generally based on total laser power output.

 

Certification of Laser Products

Laser Products introduced into commerce in the US must be certified by the manufacturer to be in compliance with regulations as specified in 21 CFR, Subchapter J, parts 1040.10 & 1040.11.  This is a process of self certification.  Certification must be completed prior to first introduction into commerce.  “Introduction into commerce” includes use, advertising or offering for sale and delivering any units.  Demonstration of your product at a trade exhibition is regarded by the CDRH as an example of “offering for sale.” 

 

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