Hearing aid user brochures
This article was originally published in The Gray Sheet
Executive SummaryFDA accepts an estimate made by the Hearing Industries Association that 136 hours are needed to prepare a new brochure, the agency says in a Feb. 4 Federal Register notice. However, "an estimate of half that time, or 68 hours, is more appropriate for preparing a revised brochure," FDA says. HIA submitted its comments in late August in response to FDA's proposed estimate of the annual reporting burden associated with its requirement that manufacturers provide hearing aid users with instructional brochures ("The Gray Sheet" Sept. 21, 1998, In Brief)
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