E8-18792. Medical Devices; Radiology Devices; Reclassification of Bone Sonometers

AGENCY:

Food and Drug Administration, HHS.

ACTION:

Final rule; correction.

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.