Zdrowie i gospodarka · 25/02/2000
Medical Devices; Hearing Aids; Technical Data Amendments; Confirmation of Effective Date
The Food and Drug Administration (FDA) is confirming the effective date of March 17, 2000, for the final rule that appeared in the Federal Register of November 3, 1999 (64 FR 59618). The direct final rule amends regulations governing hearing aid labeling to reference the most recent version of the consensus standard used to determine technical data to be included in labeling for hearing aids. This amendment allows manufacturers to use state-of-the-art methods to address technical data in labeling for hearing aids. This document confirms the effective date of the direct final rule.