Lasers: FDA publishes guidance on surveying, leveling and alignment products

Regulatory NewsRegulatory News | 30 January 2023 |  By 

The US Food and Drug Administration (FDA) has finalized a 2014 guidance that lays out its thinking what is and isn’t a regulated laser product used for surveying, leveling and alignment. While certain products such as laser pointers may harm people if misused, regulators say they will refrain from regulating low-risk products such as lasers used by observatories to make atmospheric measurements.
On 30 January, the FDA finalized its Q&A guidance that answers questions such as what constitutes a laser product used for surveying, leveling and alignment (SLA) that it will regulate. The agency notes that it has the authority to regulate radiation-emitting electronic products, including all types of lasers. As part of that mandate, it sets radiation safety product performance standards that laser manufacturers must adhere to in order to market their products.
“This guidance is intended to summarize FDA’s current thinking on the applicability of FDA’s performance standards for laser products to specific purpose SLA laser products,” said the FDA. “This guidance is not intended to serve as a replacement for the performance standards themselves.”
The FDA notes that SLA laser products are characterized in statute as those manufactured, designed, intended or promoted for “determining and delineating the form, extent, or position of a point, body, or area by taking angular measurement.” They can also be used for positioning or adjusting parts in proper relation to one another, or used to defining a plane, level, elevation, or straight line.
The agency also cautions that promotion of a multi-use laser product that has other non-SLA laser uses does not preclude it from being regulated by the FDA as long as one or more uses of the product is still considered a regulated SLA product.
The FDA lists several examples of SLA products, including laser pointers, laser levelers and other such tools, lasers used in gun sights and light detection and ranging (LIDAR) lasers that it will regulate. It also lists products that it will refrain from regulating including laser guide stars used by ground-based telescopes to compensate for atmospheric distortion of light, and certain lasers used to communicate over long distances.
For non-SLA laser products, the FDA notes that regulation still requires them to have protective housing that prevents people from accessing them during operation and avoid collateral radiation.


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