# Medical Devices; Radiology Devices; Reclassification of Bone Sonometers
> **Food and Drug Administration** · Final rule. · Published 2008-07-17 · Effective 2008-08-18 · 73 FR 40967
## Document
- **Document number:** E8-16354
- **Category:** fda-device
- **Sub-agency:** Food and Drug Administration
- **Federal Register citation:** 73 FR 40967
- **CFR reference:** 21 CFR 892
- **Publication date:** 2008-07-17
- **Effective date:** 2008-08-18
- **HHS docket:** Docket No. FDA-2005-N-0346
## Abstract

The Food and Drug Administration (FDA) is issuing a final rule to reclassify bone sonometer devices from class III into class II, subject to special controls. FDA is taking this action on its own initiative after reviewing recent scientific and technological studies regarding bone sonometer devices. Elsewhere in this issue of the Federal Register, FDA is announcing the availability of a guidance document entitled "Guidance for Industry and FDA Staff; Class II Special Controls Guidance Document: Bone Sonometers" that will serve as the special control for these devices.

## Source
- [Federal Register document](https://www.federalregister.gov/documents/2008/07/17/E8-16354/medical-devices-radiology-devices-reclassification-of-bone-sonometers)
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