Zdrowie i gospodarka · 08/10/2008
Medical Devices; Hearing Aids; Technical Data Amendments; Confirmation of Effective Date
The Food and Drug Administration (FDA) is confirming the effective date of October 15, 2008, for the final rule that appeared in the Federal Register of June 2, 2008 (73 FR 31358). The direct final rule amends the 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. This document confirms the effective date of the direct final rule.