The Center for Devices and Radiological Health (CDRH) is a regulatory bureau within the U.S. Federal Food and Drug Administration (FDA) of the Department of Health and Human Services. CDRH has been chartered by Congress to standardize the performance safety of manufactured laser products. All laser products that have been manufactured and entered into commerce, after August 2, 1976, must comply with these regulations.
The regulation is known as the Federal Laser Product Performance Standard (FLPPS), and is identified as 21CFR subchapter parts 1040.10 and 1040.11. The FLPPS assigns lasers into one of four broad hazards in a manner similar to the ANSI Z136.1 (2000) Standard - Classes I, II, IIIa, IIIb and IV) depending on the potential for causing biological damage.
Class I laser product means any laser product that does not permit human access during the operation to levels of laser radiation in excess of the accessible emission limits as defined in Table I of 21 CFR Subchapter J Part 1040.10. Class I levels of laser radiation are not considered to be hazardous.
Class II laser product means any laser product that permits human access during operation to levels of visible laser radiation in excess of the accessible emission limits contained in Table II-A of 21 CFR Subchapter J Part 1040.10, but does not permit human access during operation to levels of laser radiation in excess of the accessible emission limits contained in Table II of 21 CFR Subchapter J Part 1040.10. Class II levels of laser radiation are considered to be a chronic viewing hazard.
Class IV laser product means any laser that permits human access during operation to levels of laser radiation in excess of the accessible emission limits contained in Table III-B of 21 CFR Subchapter J Part 1040.10. Class IV levels of laser radiation are considered to be an acute hazard to the skin and eyes from direct and scattered radiation. Class IV laser products may have removable panels that, when displaced, permit access to levels of laser radiation ranging from Class II to Class IV.