[Federal Register Volume 72, Number 112 (Tuesday, June 12, 2007)]
[Notices]
[Pages 32299-32300]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: E7-11235]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. 2006D-0020]


Guidance for Industry and Food and Drug Administration Staff; 
Class II Special Controls Guidance Document: Intervertebral Body Fusion 
Device; Availability

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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SUMMARY: The Food and Drug Administration (FDA) is announcing the 
availability of the guidance document entitled ``Class II Special 
Controls Guidance Document: Intervertebral Body Fusion Device.'' It was 
developed as a special control to support the reclassification of 
intervertebral body fusion devices that contain bone grafting material 
from class III (premarket approval) into class II (special controls). 
The guidance document describes a means by which these intervertebral 
body fusion devices may comply with the requirement of special controls 
for class II devices. Elsewhere in this issue of the Federal Register, 
FDA is publishing a final rule to reclassify the intervertebral body 
fusion device that contain bone grafting material from class III into 
class II (special controls) and retain those that contain any 
therapeutic biologic (e.g., bone morphogenic protein) in class III.

DATES: Submit written or electronic comments on this guidance at any 
time.

[[Page 32300]]

General comments on agency guidance documents are welcome at any time.

ADDRESSES: Submit written requests for single copies of the guidance 
document entitled ``Class II Special Controls Guidance Document: 
Intervertebral Body Fusion Device'' 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 240-276-3151. See the SUPPLEMENTARY INFORMATION section for 
information on electronic access to the guidance.
    Submit written comments concerning this 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: Jodi N. Anderson, Center for Devices 
and Radiological Health (HFZ-410), Food and Drug Administration, 9200 
Corporate Blvd., Rockville, MD 20850, 240-276-3680.

SUPPLEMENTARY INFORMATION:

I. Background

    In the Federal Register of February 9, 2006 (71 FR 6778), FDA 
announced the availability of the draft guidance document entitled 
``Class II Special Controls Guidance Document: Class II Special 
Controls Guidance Document: Intervertebral Body Fusion Device.'' 
Interested persons were invited to comment on the draft guidance 
document by May 10, 2006.
    In the same Federal Register (71 FR 6710), FDA published a proposed 
rule to reclassify the intervertebral body fusion devices that contain 
bone grafting material, from class III (premarket approval) into class 
II (special controls), and retain those that contain any therapeutic 
biologic (e.g., bone morphogenic protein) in class III. FDA received 
twelve comments on the proposed rule and draft guidance. Ten comments 
were on the proposed rule and are addressed in the final rule published 
elsewhere in this issue of the Federal Register. The two comments on 
the draft guidance suggested that FDA clarify its discussion of device 
sterilization and mechanical testing. FDA has updated the guidance to 
clarify its recommendations about these two topics.

II. Significance of Guidance

    This guidance is being issued consistent with FDA's good guidance 
practices regulation (21 CFR 10.115). The guidance represents the 
agency's current thinking on intervertebral body fusion devices. It 
does not create or confer any rights for or on any person and does 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. Electronic Access

    Persons interested in obtaining a copy of the draft guidance may do 
so by using the Internet. To receive ``Class II Special Controls 
Guidance Document: Class II Special Controls Guidance Document: 
Intervertebral Body Fusion Device'' you may either send an e-mail 
request to [email protected] to receive an electronic copy of the 
document or send a fax request to 240-276-3151 to receive a hard copy. 
Please use the document number 1540 to identify the guidance you are 
requesting.
    CDRH maintains an entry 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. The CDRH Web site may be accessed at http://www.fda.gov/cdrh. A search capability for all CDRH guidance documents is available 
at http://www.fda.gov/cdrh/guidance.html. Guidance documents are also 
available on the Division of Dockets Management Internet site at http://www.fda.gov/ohrms/dockets.

IV. Paperwork Reduction Act of 1995

    This guidance refers to previously approved collections of 
information found in FDA regulations. These collections of information 
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 in 21 CFR part 807, subpart E 
have been approved under OMB control number 0910-0120; and the 
collections of information in 21 CFR part 801 have been approved under 
OMB control number 0910-0485.

V. Comments

    Interested persons may submit to the Division of Dockets Management 
(see ADDRESSES) written or electronic comments regarding this document. 
Submit a single copy of electronic comments or two paper copies of any 
mailed comments, except that individuals may submit one paper copy. 
Comments are to be identified with the docket number found in brackets 
in the heading of this document. Received comments may be seen in the 
Division of Dockets Management between 9 a.m. and 4 p.m., Monday 
through Friday.

    Dated: May 31, 2007.
Linda S. Kahan,
Deputy Director, Center for Devices and Radiological Health.
[FR Doc. E7-11235 Filed 6-11-07; 8:45 am]
BILLING CODE 4160-01-S