Medical Devices; Hearing Aids; Technical Data Amendments; Confirmation of Effective Date
fda-device · Food and Drug Administration · Rule · Published 2008-10-08 · Effective 2008-10-15 · 73 FR 58874
Document
Document number
E8-23717
Federal Register citation
73 FR 58874
CFR reference
21 CFR 801
Type
Rule
Action
Direct final rule; confirmation of effective date.
Category
fda-device
Sub-agency
Food and Drug Administration
Publication date
2008-10-08
Effective date
2008-10-15
HHS docket
Docket No. FDA-2008-N-0148
Abstract
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.