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In-eye contact lens care products need data from 30 patients to support approval -- FDA.

This article was originally published in The Tan Sheet

Executive Summary

IN-EYE LENS CARE PRODUCT 510(k)s NEED DATA FROM AT LEAST 30 PATIENTS, FDA says in its recently released final 510(k) (abbreviated approval) guidance for the devices/products. The guidance covers contact lens care products such as rigid gas permeable (RGP) and soft contact lens solutions, contact lens cases and heat disinfection units. Although the guidance is final, FDA says "comments and suggestions may be submitted at any time for agency consideration."
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