[Federal Register Volume 73, Number 246 (Monday, December 22, 2008)]
[Notices]
[Pages 78372-78373]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: E8-30440]



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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2008-D-0603]


Draft Guidance for Industry and Food and Drug Administration 
Staff; Class II Special Controls Guidance Document: Tissue Expander; 
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availability of the draft guidance entitled ``Class II Special Controls 
Guidance Document: Tissue Expander.'' This draft guidance document 
describes a means by which the tissue expander device type may comply 
with the requirement of special controls for class II devices. 
Elsewhere in this issue of the Federal Register, FDA is publishing a 
proposed rule to classify this device type into class II (special 
controls). This draft guidance is not final nor is it in effect at this 
time.

DATES:  Although you can comment on any guidance at any time (see 21 
CFR 10.115 (g)(5)), to ensure that the agency considers your comment on 
this draft guidance before it begins work on a final version of the 
guidance, submit written or electronic comments on the draft guidance 
by March 23, 2009.

ADDRESSES:  Submit written requests for single copies of the FDA draft 
guidance document entitled ``Class II Special Controls Guidance 
Document: Tissue Expander'' 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    Submit written comments concerning this draft guidance to the 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.regulations.gov. Identify comments with the 
docket number found in brackets in the heading of this document.

FOR FURTHER INFORMATION CONTACT: Nada Hanafi, Center for Devices and 
Radiological Health (HFZ-4), Food and Drug Administration, 7520 
Standish Pl., Rockville, MD 20855, 240-276-8848

SUPPLEMENTARY INFORMATION:

I. Background

    A tissue expander is a device intended for temporary (less than 6 
months) subdermal implantation to stretch the skin for surgical 
applications, specifically to develop surgical flaps and additional 
tissue coverage. It is made of an inflatable silicone elastomer shell 
filled with Normal Physiological Saline (injection grade). On August 25 
and 26, 2005, the General and Plastic Surgery Devices Panel (the Panel) 
recommended that the tissue expander be classified into class II and 
that the special control should be a special controls guidance document 
and labeling. The Panel also considered the types of information the 
agency should include in a class II special controls guidance document. 
FDA considered the Panel's recommendations and, elsewhere in this issue 
of the Federal Register, FDA is proposing to classify the tissue 
expander into class II. If this classification rule is finalized, FDA 
intends that this guidance document will serve as the special control 
for this device.
    Following the effective date of any final classification rule based 
on this proposal, any firm submitting a premarket notification (510(k)) 
for a tissue expander will need to address the issues covered in the 
special controls guidance document. However, the firm need only show 
that its device meets the recommendations of the guidance document or 
in some other way provides equivalent assurances of safety and 
effectiveness.

II. Significance of Guidance

    This draft guidance is being issued consistent with FDA's good 
guidance practices regulation (21 CFR 10.115). The draft guidance, when 
finalized, will represent the agency's current thinking on the tissue 
expander device type. 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: Tissue Expander,'' 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 1628 to identify the guidance you are 
requesting.
    The Center for Devices and Radiological Health (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 at http://www.regulations.gov.

IV. Paperwork Reduction Act of 1995

    This draft 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 (44 U.S.C. 3501-3520). The 
collections of information in 21 CFR part 807, subpart E, have been 
approved under OMB control no. 0910-0120; the collections of 
information in 21 CFR part 820 have been approved under OMB control no. 
0910-0073; the collections of information in 21 CFR part 812 have been 
approved under OMB control no. 0910-0078; the collections of 
information in 21 CFR parts 50 and 56 have been approved under OMB 
control no. 0910-0130; 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 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.
    Please note that on January 15, 2008, the FDA Division of Dockets

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Management Web site transitioned to the Federal Dockets Management 
System (FDMS). FDMS is a Government-wide, electronic docket management 
system. Electronic comments or submissions will be accepted by FDA only 
through FDMS at http://www.regulations.gov.

    Dated: December 16, 2008.
Jeffrey Shuren,
Associate Commissioner for Policy and Planning.
[FR Doc. E8-30440 Filed 12-19-08; 8:45 am]
BILLING CODE 4160-01-S