FDA Center for Devices and Radiological Health / CDRH

Laser Radiation Safety

All laser devices distributed in the U.S. are subject to Mandatory Performance Standards. They must meet the Federal laser product performance standard and must submit an "initial report" to CDRH's Office of Compliance prior to distributing the product in compliance with CFR 1040.

This performance standard specifies the safety features and labeling that all laser products must have in order to provide adequate safety to users.

A laser product manufacturer must certify that each model complies with the standard before introducing the laser into U.S. commerce. This includes distribution for use during clinical investigations prior to device approval.

Certification of a laser product means that each unit has passed a quality assurance test and that it complies with the performance standard.

The firm that certifies a laser product assumes responsibility for product reporting, recordkeeping, and notification of defects, noncompliances, and accidental radiation occurrences, as specified in sections 21 CFR 1000-1010.

Reporting guides and related regulatory information are available from the DSMA web site at: http://www.fda.gov/cdrh/devadvice. Distribution of any certified laser products internationally would also require submission of the report.