FDA finalizes guidance allowing some contact lens sponsors 510(k) predicate leeway

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.

Other contact lenses, such as those intended to treat presbyopia, enhance or alter the apparent color of the eye, or act as a bandage or therapeutic lens are not eligible for the pathway, according to the guidance. The final guidance also clarifies that contact lenses with special optical performance beyond that of correcting ametropia and those with special health performance characteristics such as for relieving dry eye are also not covered by the guidance. The draft guidance, issued in 2020, was not as specific (RELATED: Contact Lenses: CDRH Drafts Guidance on Performance Criteria to Support 510(k)s, Regulatory Focus, 3 March 2020).

“Consistent with FDA policy for all 510(k) submissions, for all 510(k) submissions under the Safety and Performance Based Pathway, FDA may request and review underlying data demonstrating that a new device meets the FDA-identified performance criteria and testing methodology, as necessary,” the agency added.

Besides clarifying what devices fall under the guidance and what don’t, FDA has also added a number of new standards that sponsors can use to show their product fulfills requirements such as those to demonstrate certain mechanical properties, sterilization, and biocompatibility. In particular, the agency added standards that address cytotoxicity, sensitization, and ocular irritation to demonstrate their biocompatibility.

Final Guidance

FDA finalizes guidance allowing some contact lens sponsors 510(k) predicate leeway

Related topics

Recommended content

Welcome to the new RAPS Digital Experience