Medical Devices; Hearing Aids; Technical Data Amendments; Confirmation of Effective Date
fda-device · Food and Drug Administration · Rule · Published 2000-02-25 · Effective 2000-03-17 · 65 FR 10012
Document
Document number
00-4404
Federal Register citation
65 FR 10012
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
2000-02-25
Effective date
2000-03-17
HHS docket
Docket No. 99N-2550
Abstract
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.