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

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.

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

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