Q. What regulations apply to sports

Q. What regulations apply to sports goggles, such as skiing, swimming, and snorkeling?A. Sports goggles with prescription lenses are regulated as devices. Manufacturers must meet all applicable device regulations, including impact resistance (21 CFR 801.410), establishment registration (21 CFR Part 807), device listing (21 CFR Part 807), quality system regulation (21 CFR Part 820), and medical device reporting (21 CFR Part 803). Prescription sports goggles should also meet the appropriate safety standards for the sport. Non-corrective sports goggles that do not make any sun protection claims are not regulated as devices. Therefore, no device regulations, such as registration or listing, apply.18. Q. What regulations apply if sports goggles use the following claims: "Blocks UV,” “Blocks Sunrays," or makes other sunglass claims?A. FDA regulates goggles, including sports goggles and tanning bed goggles, that make such claims as sunglasses. Therefore, goggles making such claims must meet the same regulations as sunglasses, including impact resistance. 21 CFR 801.410.19. Q. What regulations apply to demonstration lenses used in eyeglasses and sunglasses for retail display?A. Demonstration lenses are typically not rendered impact resistant as they are not intended to be sold to consumers. You should take precautions to assure that display units containing demonstration lenses that are not impact-resistant are not sold to the consumer. Manufacturers of eyeglass or sunglass frames with demonstration lenses can use various options to ensure these units are not used by consumers. The options include the following:1. You may have the word “demonstration” etched in the lower quadrant of at least one lens in each pair of eyeglasses. The letters should be large enough to be seen easily with normal vision.