I was reminded this month that the FDA is the regulatory body for a wide variety of radiation-emitting products available in the U.S. when I received this notice of the final guidance “Classification and Requirements for Laser Illuminated Projectors”. That’s right, this is guidance for projectors that use lasers instead of conventional lamps for illumination. The guidance points out that such projectors “may be used in locations such as indoor or outdoor cinema theaters, laser shows, presentations at conventions, as image/data projectors in an office setting, or in a home”. The guidance clarifies the requirements for projectors based on their optical safety risk group.  These risk groups are defined in the international standard “International Electrotechnical Commission (IEC) 60825-1 Ed. 3.0: Safety of laser products – Part 1: Equipment classification, and requirements”.  While such projectors are not medical devices, CDRH is the governing division under the law. 

The laws for regulation of radiation emitting products cover the more obvious medical scanning devices such as X-ray or MRI equipment, ultrasound equipment, and lasers used for research and surgery. They also cover a wide range of commercially available products such as TVs and monitors, cell phones, and microwave ovens. Take a look at a current list of radiation emitting products (including a diagram showing the laws governing their regulation and how they overlap) at this page.

Text Copyright © 2019 Katrina Rogers