Update Jan. 17, 06

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Update Jan. 17, 06

FDA Issues Guidance “Exemption from Reporting and Recordkeeping Requirements for Low Power Laser Products”

With this guidance, FDA provides notification of exemption of specified low power laser products from certain reporting requirements because of the low risk of exposure to laser radiation and minimal risk to health posed by the products identified in this document.

The following Class I products are exempted:

Optical disc products, such as CD or DVD players, readers, or recorders, whether the products are stand-alone units, installed into other systems (such as computers or automobiles), or intended to be installed into other systems.
Laser printers
Fax machines
Other similar products for which the maximum accessible laser radiation emitted by the product under any condition of operation, maintenance, service, or failure does not exceed the class I accessible emission limits in 21 CFR 1040.10(d), as determined in accordance with 21 CFR 1040.10(e)

Manufacturers of the class I laser products described above are exempted from:

Certain product reports required by 21 CFR 1002.10
All supplemental reports required by 21 CFR 1002.11
Certain recordkeeping requirements described in 21 CFR 1002.30(b), 1002.40 and 1002.41

For a complete copy of this guidance, please visit: http://www.fda.gov/cdrh/comp/guidance/1592.pdf

If you have any comments regarding this update, please email: info@mdiconsultants.com

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