Change Overdue for Lens-Related Guidance
BY JASON J. NICHOLS, OD, MPH, PHD, FAAO
If you think back in time regarding the history of contact lens introductions, the first soft lens was introduced (in the United States) in the early 1970s. Multipurpose care solutions as we know them today were introduced in the mid-1990s, and we have seen many enter (and a few leave) the market since that time. The U.S. Food and Drug Administration (FDA) regulates both daily wear soft contact lenses and care solutions as Class II medical devices. The FDA issued guidance documents to industry for soft lenses in 1991 (20 years after it approved the first soft lens in the United States) and in 1997 for care solutions.
The guidance document for contact lens care systems is titled “Premarket Notification (510(k)) Guidance Document for Contact Lens Care Products,” and it covers the range of associated products including salines, cleaners, chemical disinfecting/multipurpose solutions, lubricating/rewetting drops, heat disinfection, contact lens cases, and contact lens accessories (such as cleaning aids and pads). The document provides recommended test methods in terms of chemistry, microbiology, toxicology, shelf-life, and clinical testing.
With all of this in mind, I think it is important to point out that we’ve had significant changes in the product landscape associated with both contact lens materials and care solutions since these guidance documents were published. We’ve had entirely new contact lens materials (e.g., silicone hydrogels) introduced in addition to fairly significant changes in the formulations of contact lens care systems. Unfortunately, it seems to have taken two care solution product recalls associated with Fusarium and Acanthamoeba keratitis outbreaks to initiate the process of updating these perhaps dated documents. And although this process is ongoing, to date the end appears nowhere in sight. While we appreciate that the FDA needs to be thorough, it would be beneficial if the process could be expedited so that we can have updated guidance in place.