U.S. Regulations & Manufacturing Standards Covering Medical Devices Sold in the U.S.
The Guide to U.S. Regulations & Manufacturing Standards Covering Eyeglass Frames, Prescription Lenses and Finished Eyewear Sold in the U.S. (May 2013) is intended for manufacturers, exporters, importers, retailers, and eye care professionals. This document provides pertinent information about the U.S. regulations and national manufacturing standards that affect the manufacture and sale of eyeglasses, eyeglass frames and prescription lenses (products regulated as "medical devices") in the United States.