Nonprescription sunglasses remain subject to regulations such as those identified as “general controls”, which are applicable to all class I devices, and impact resistant lens requirements. In addition, there are limitations placed on the exemption of nonprescription sunglasses, as described in 21 CFR 886.9 and in the February 2, 1998 Federal notice. To avoid unnecessary or inadvertent violations of the Act, thelimitations of the exemption must be clearly understood prior to marketing sunglasses in the United States without a determination of substantial equivalence from FDA through the 510(k) process.
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