[Federal Register Volume 71, Number 31 (Wednesday, February 15, 2006)]
[Notices]
[Pages 7976-7977]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: E6-2078]


-----------------------------------------------------------------------

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. 2003D-0420]


Draft Guidance for Industry and Food and Drug Administration 
Staff; Medical Devices: Radiology Devices; Class II Special Controls 
Guidance Document: Bone Sonometers; Availability

AGENCY: Food and Drug Administration, HHS.

[[Page 7977]]


ACTION: Notice.

-----------------------------------------------------------------------

SUMMARY: The Food and Drug Administration (FDA) is announcing the 
availability of a draft guidance for industry and FDA staff entitled 
``Class II Special Controls Guidance Document: Bone Sonometers.'' The 
draft guidance was developed to support the reclassification of bone 
sonometers from class III (premarket approval) into class II (special 
controls). Elsewhere in this issue of the Federal Register, FDA is 
publishing a proposed rule to reclassify these devices accordingly. 
This draft guidance is neither final nor is it in effect at this time.

DATES: Submit written or electronic comments on the draft guidance by 
May 16, 2006.

ADDRESSES: Submit written requests for single copies on a 
3.5 diskette of the draft guidance document entitled ``Class 
II Special Controls Guidance Document: Bone Sonometers'' to the 
Division of Small Manufacturers, International, and Consumer Assistance 
(HFZ-220), Center for Devices and Radiological Health, Food and Drug 
Administration, 1350 Piccard Dr., Rockville, MD 20850. Send one self-
addressed adhesive label to assist that office in processing your 
request, or fax your request to 301-443-8818. See the SUPPLEMENTARY 
INFORMATION section for information on electronic access to the 
guidance.
    Submit written comments concerning this draft guidance to the 
Division of Dockets Management (HFA-305), Food and Drug Administration, 
5630 Fishers Lane, rm. 1061, Rockville, MD 20852. Submit electronic 
comments to http://www.fda.gov/dockets/ecomments. Identify comments 
with the docket number found in brackets in the heading of this 
document.

FOR FURTHER INFORMATION CONTACT: Robert A. Phillips, Center for Devices 
and Radiological Health (HFZ-470), Food and Drug Administration, 9200 
Corporate Blvd., Rockville, MD 20850, 301-594-1212, ext. 130.

SUPPLEMENTARY INFORMATION:

I. Background

    This draft guidance provides FDA's recommendations to manufacturers 
of bone sonometers for identifying risks to health and mitigation 
measures that can be taken to offset those risks. Bone sonometers are 
devices that transmit ultrasound energy into the human body to measure 
acoustic properties of bone that indicate overall bone health and 
fracture risk. These devices were classified into class III by statute 
(section 513(f)(1) of the Federal Food, Drug, and Cosmetic (the act) 
(21 U.S.C. 360e(f)(i))), however, FDA believes that sufficient 
information exists to establish special controls that, when followed 
and combined with the general controls of the act, would provide 
reasonable assurance of the safety and effectiveness of these devices.

II. Significance of the Guidance

    This draft guidance is being issued consistent with FDA's good 
guidance practice regulation (21 CFR 10.115). The draft guidance, if 
finalized, would represent the agency's current thinking on bone 
sonometers. It would not create or confer any rights for or on any 
person and would not operate to bind FDA or the public. An alternative 
approach may be used if such approach satisfies the requirements of the 
applicable statute and regulations.

III. Paperwork Reduction Act of 1995

    This draft guidance contains information collection provisions that 
are subject to review by the Office of Management and Budget (OMB) 
under the Paperwork Reduction Act of 1995 (the PRA) (44 U.S.C. 3501-
3520). The collections of information addressed in the draft guidance 
have been approved by OMB in accordance with the PRA under the 
regulations governing premarket notification submissions (21 CFR part 
807, subpart E, OMB control number 0910-0120), which expires May 31, 
2007. The labeling provisions addressed in the draft guidance have been 
approved by OMB under the PRA under OMB control number 0910-0485 and 
expires June 30, 2008.

IV. Comments

    Interested persons may submit written or electronic comments on the 
draft guidance to the Division of Dockets Management (see ADDRESSES). 
Submit a single copy of electronic comments or two paper copies of any 
mailed comments, except that an individual may submit one paper copy. 
Identify comments with the docket number found in brackets in the 
heading of this document. The draft guidance and received comments are 
available for public examination in the Division of Dockets Management 
between 9 a.m. and 4 p.m., Monday through Friday.

V. Electronic Access

    The Center for Devices and Radiological Health (CDRH) Web site may 
be accessed at http://www.fda.gov/cdrh. A search capability for all 
CDRH guidance documents is also available on the Division of Dockets 
Management Internet site at http://www.fda.gov/ohrms/dockets.
    To receive a copy of ``Class II Special Controls Guidance Document: 
Bone Sonometers,'' by fax, call the CDRH Facts-On-Demand system at 800-
899-0381 or 301-827-0111 from a touch-tone telephone. Press 1 to enter 
the system. At the second voice prompt, press 1 to order a document. 
Enter the document number (1547) followed by the pound sign 
(). Follow the remaining voice prompts to complete your 
request.
    Persons interested in obtaining a copy of the draft guidance may 
also do so by using the Internet. CDRH maintains a site on the Internet 
for easy access to information including text, graphics, and files that 
may be downloaded to a personal computer with Internet access. Updated 
on a regular basis, the CDRH home page includes device safety alerts, 
Federal Register reprints, information on premarket submissions 
(including lists of approved applications and manufacturers' 
addresses), small manufacturer's assistance, information on video 
conferencing and electronic submissions, Mammography Matters, and other 
device-oriented information.

    Dated: January 17, 2006.
Linda S. Kahan,
Deputy Director, Center for Devices and Radiological Health.
[FR Doc. E6-2078 Filed 2-14-06; 8:45 am]
BILLING CODE 4160-01-S