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.”…
