The US Food and Drug Administration has finalized a guidance that allows some manufacturers to submit 510(k) applications for soft contact lenses based on their performance criteria rather than by comparison to a predicate device.
“FDA recognizes that in some cases, it may be more burdensome for a submitter to conduct testing against an appropriate predicate device to demonstrate equivalence for the necessary set of performance and technological characteristics than to demonstrate their device meets appropriate performance criteria established by FDA,” FDA wrote in the final guidance issued 28 March. “Accordingly, we concluded that the optional device-specific Safety and Performance Based Pathway utilizing the performance criteria identified in this guidance provides a less burdensome policy consistent with the public health.”
The guidance outlines what kinds of soft contact lenses are eligible to use the alternative pathway. More specifically, the agency says soft daily wear prescription contacts that are meant to be worn directly against the cornea and adjacent limbal and scleral areas of the eye for myopia or hyperopia with or without astigmatism could qualify…
