Nonprescription sunglasses remain subject to regulations such as those identified as "general controls", which are applicable to all class I medical devices, and impact resistant lens requirements. ITB HOLDINGS LLC 390 North Orange Avenue, Suite 2300 Orlando, FL 32801 United States T: +1 855 389 7344 T: +1 855 510 2240 T: +44 800 610 1577 https://www.fda.itbhdg.com/product/medical-devices/