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FDA Issues Final Guidance on Surveying, Leveling, and Alignment Laser Products

By MedTech Intelligence Staff
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The guidance defines SLA and non-SLA laser products and provides information on how to request a variance or exemption from SLA class limits.

On January 30, the FDA issued its final guidance on Surveying, Leveling, and Alignment (SLA) Laser Products for manufacturers of laser products. The final guidance outlines the FDA’s approach on the applicability of the FDA’s performance standard regulations to surveying, leveling, and alignment (SLA) laser products, and covers:

  • The definition of an SLA laser product
  • Considerations for what is an SLA laser product
  • Examples of SLA and non-SLA laser products
  • SLA laser product class limits
  • Requesting a variance or exemption from SLA laser product class limits

The guidance defines an SLA as “Any laser product manufactured, designed, intended, or promoted to transmit laser radiation through open space outside a protective housing for a surveying, leveling, or alignment use … FDA would consider design features that allow the laser product to be portable (e.g., handheld, battery operated) and transmit through open space (e.g., lacking features for a protective housing or optical fiber connections) to be factors supporting that the product is manufactured, designed, or intended for SLA laser product purposes.”

Products that are not considered SLA include laser products that are manufactured, designed, intended, and promoted only as general purpose laser light sources or for laboratory research purposes such as fluorescence-based applications, flow cytometry, confocal microscopy, and multi-array readers, or for bench research purposes.

Download the final guidance here.



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