Laser products; amendments to performance standard--FDA. Final rule

The Food and Drug Administration (FDA) is amending the performance standard for laser products to widen the wavelength range that defines laser radiation, to establish a new "Class IIIa" laser product, and to add new reporting and recordkeeping requirements for sales of original equipment manufacturer (OEM) components. The amendments relax the current performance requirements for safety interlocks, viewing optics, remote control connectors, emission delay, key controls, and beam attenuators. Also, the amendments simplify and make clear the protective housing requirements for any laser product, the definitions for "human access," and the existing laser product classes. Additionally, FDA is modifying the requirements for certain radiation measurement parameters, scanning failure safeguards, manual reset mechanisms, and emission indicators on certain laser products. FDA's experience in administering the laser product standard has shown the need to implement these changes.