Document ID: FDA-2005-N-0346-0003
Agency: fda
Document Type: Notice
Title: Medical Devices; Radiology Devices; Reclassification of Bone Sonometers
Posted Date: 2008-08-14T04:00Z

[Federal Register: August 14, 2008 (Volume 73, Number 158)]
[Rules and Regulations]               
[Page 47523]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr14au08-1]                         

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[[Page 47523]]

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

21 CFR Part 892

[Docket No. FDA-2005-N-0346] (formerly 2005N-0467)

 
Medical Devices; Radiology Devices; Reclassification of Bone 
Sonometers

AGENCY: Food and Drug Administration, HHS.

ACTION: Final rule; correction.

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SUMMARY: The Food and Drug Administration (FDA) is correcting a final 
rule that appeared in the Federal Register of July 17, 2008 (73 FR 
40967). The final rule reclassified bone sonometer devices from class 
III into class II, subject to special controls. The document contained 
an inadvertent error regarding the impact of the final rule on small 
businesses. This document corrects that error.

FOR FURTHER INFORMATION CONTACT: Domini Cassis, Center for Devices and 
Radiological Health (HFZ-215), Food and Drug Administration, 1350 
Piccard Dr., Rockville, MD 20850, 240-276-2342.

SUPPLEMENTARY INFORMATION: In FR Doc. E8-16354, appearing on page 40969 
in the Federal Register of Thursday, July 17, 2008, there was an error 
regarding the impact of the final rule on small businesses. 
Specifically, language certifying that the final rule meets the 
requirements of the Regulatory Flexibility Act (5 U.S.C. 601-612) was 
inadvertently omitted during document preparation. Accordingly, the 
following correction is made:
    1. On page 40969, in the middle column, under section ``VI. 
Analysis of Impacts,'' in the second full paragraph, the third sentence 
is revised to read: ``The agency certifies that the final rule will not 
have a significant economic impact on a substantial number of small 
entities.''

    Dated: August 8, 2008.
Jeffrey Shuren,
Associate Commissioner for Policy and Planning.
[FR Doc. E8-18792 Filed 8-13-08; 8:45 am]

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