Medical devices; warning statements for devices containing or manufactured with chlorofluorocarbons and other class I ozone-depleting substances.

21 C.F.R. § 801.63
in effectEffective: 2024-07-01
Sign in to generate a plain English summaryAsk Belisarius Agent
(a) All over-the-counter devices containing or manufactured with chlorofluorocarbons, halons, carbon tetrachloride, methyl chloride, or any other class I substance designated by the Environmental Protection Agency (EPA) shall carry one of the following warnings: (1) The EPA warning statement: (2) The alternative statement: (b) The warning statement shall be clearly legible and conspicuous on the product, its immediate container, its outer packaging, or other labeling in accordance with the requirements of 40 CFR part 82 and appear with such prominence and conspicuousness as to render it likely to be read and understood by consumers under normal conditions of purchase. This provision does not replace or relieve a person from any requirements imposed under 40 CFR part 82. Warning: Contains [or Manufactured with, if applicable] [insert name of substance], a substance which harms public health and environment by destroying ozone in the upper atmosphere.

Starting a business? Corpus forms LLCs in all 50 states and DC.