Document ID: FDA-2008-N-0148-0004
Agency: fda
Document Type: Rule
Title: Medical Devices; Hearing Aids; Technical Data Amendments; Confirmation of Effective Date
Posted Date: 2008-10-08T04:00Z

[Federal Register: October 8, 2008 (Volume 73, Number 196)]
[Rules and Regulations]               
[Page 58874-58875]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr08oc08-6]                         

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

21 CFR Part 801

[Docket No. FDA-2008-N-0148]

 
Medical Devices; Hearing Aids; Technical Data Amendments; 
Confirmation of Effective Date

AGENCY:  Food and Drug Administration, HHS.

ACTION:  Direct final rule; confirmation of effective date.

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SUMMARY:  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.

DATES: Effective date confirmed: October 15, 2008.

FOR FURTHER INFORMATION CONTACT: Eric A. Mann, Center for Devices and 
Radiological Health (HFZ-460), Food and Drug Administration,9200 
Corporate Blvd., Rockville, MD 20850, 240-276-4242.

SUPPLEMENTARY INFORMATION: In the Federal Register of June 2, 2008 (73 
FR 31358), FDA solicited comments concerning the direct final rule for 
a 75-day period ending August 18, 2008. FDA stated that the effective 
date of the direct final rule would be on October 15, 2008, 60 days 
after the end of the comment period, unless any significant adverse 
comment was submitted to FDA during the comment period. FDA received 
one letter of comment on the direct final rule. However, this comment 
does not constitute a significant adverse comment. Therefore, FDA is 
confirming the effective date of the direct final rule. The comment 
received and FDA's response to the comment are discussed as follows:
    The only comment on the direct final rule requested clarification 
regarding the applicability of the proposed change in the standard of 
the American National Standards Institute to hearing aid models that 
were tested and characterized prior to the effective date

[[Page 58875]]

of the direct final rule on October 15, 2008. The comment interpreted 
the proposed change as being only prospectively applied to new models 
undergoing test procedures on or after the effective date of the 
proposed change. FDA agrees that the proposed change applies only to 
new hearing aid models undergoing characterization on or after the 
effective date of October 15, 2008; hearing aid models tested prior to 
this date are subject only to the characterization standard cited in 
the regulation at the time they were tested.

    Authority: Therefore, under the Federal Food, Drug, and Cosmetic 
Act and the Public Health Service Act, and under authority delegated 
to the Commissioner of Food and Drugs, the amendments issued thereby 
become effective on October 15, 2008.

    Dated: October 2, 2008.
Jeffrey Shuren,
Associate Commissioner for Policy and Planning.
[FR Doc. E8-23717 Filed 10-7-08; 8:45 am]

BILLING CODE 4160-01-S