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. A certifier of a laser product is required to report the product via a Laser Product Report submitted to CDRH. 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.