Medical Devices; Radiology Devices; Reclassification of Bone Sonometers
fda-device · Food and Drug Administration · Rule · Published 2008-08-14 · 73 FR 47523
Document
Document number
E8-18792
Federal Register citation
73 FR 47523
CFR reference
21 CFR 892
Type
Rule
Action
Final rule; correction.
Category
fda-device
Sub-agency
Food and Drug Administration
Publication date
2008-08-14
HHS docket
Docket No. FDA-2005-N-0346
Abstract
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.