FDA Proposes Improving Contact Lens Product Testing and Advocating Universal Lens-care Guidelines


At the US Food and Drug Administration meeting in Washington last week, the eye experts have recommended some improved contact lens product testing. They also advocated universal lens-care guidelines to improve contact lens safety. A coalition of US ophthalmic organizations recommended the FDA to work closely with industry to expand and strengthen contact lens solution to protect consumers.

According to the panel of eye experts, there should be updated lens solution guidelines. A standardized and validated testing protocol should be adopted to ensure that all contact lens products are meeting the same demands. CL solution testing should be more rigorous to include standardized real-world scenarios. Also the panel of eye experts suggested that the FDA should re-examine the equivalency testing to determine if new products are substantially similar to existing approved products, when a revised formula is submitted. Each product should be evaluated on its own.

The organizations recommended the FDA to consider the feasibility of developing a mechanism to monitor contact lens infections. Contact lens solution testing should be updated to ensure that products are effective against a more diverse and representative set of infectious organisms, including Acanthamoeba.

In a statement, the American Academy of Ophthalmology, spokesman Elmer Tu, director of the cornea and external disease service at the University of Illinois, said: "Now is the time to tighten the safety net around contact lens products. While improved testing and consumer awareness of lens-care guidelines may not prevent future outbreaks of eye infections, they will provide an important additional layer of safety for contact lens wearers."

Source: The Optician

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