Medical devices; hearing aids; technical data amendments. Direct final rule.
The Food and Drug Administration (FDA) is amending its regulations governing hearing aid labeling to reference the most recent version of the consensus standard used to determine the technical data to be included in labeling for hearing aids. We are amending the regulations to require that manufacturers may use state-of-the-art methods to provide technical data in hearing aid labeling. FDA is also amending the regulations to update an address and remove an outdated requirement. FDA is amending the regulations in accordance with its direct final rule procedures. Elsewhere in this issue of the Federal Register, we are publishing a companion proposed rule under FDA's usual procedures for notice and comment rulemaking to provide a procedural framework to finalize the rule in the event we receive a significant adverse comment and withdraw this direct final rule.
D006310:Hearing Aids / Q000592:standards*; D006801:Humans; D011356:Product Labeling / Q000331:legislation & jurisprudence* / Q000592:standards; D014481:United States; D014486:United States Food and Drug Administration