What are the FDA’s requirements for the physical properties of lenses or the design of lenses?
A. The regulation requires only that lenses be made impact resistant and are impact tested. FDA has no other device specific property or design requirements imposed on lenses by regulation. 58. Q. Are there additional requirements for rimless eyewear? A. No. Rimless eyewear must meet the same requirements as framed eyewear, including impact testing. 59. Q. What are the FDA regulations for spectacle frames? A. A spectacle frame is a device made of metal or plastic intended to hold prescription spectacle lenses worn by a patient to correct refractive errors. Spectacle frames are regulated as Class I medical devices classified under 21 CFR 886.5842. They are exempt from Premarket Notification (510(k)). You can find the regulatory requirements for spectacle frames in “Sunglasses, Spectacle Frames, Spectacle Lens and Magnifying Spectacles” on the Internet.
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