Document ID: FDA-2008-D-0603-0001
Agency: fda
Document Type: Notice
Title: Draft Guidance for Industry and Food and Drug Administration Staff; Class II Special Controls Guidance Document: Tissue Expander; Availability
Posted Date: 2008-12-22T05:00Z

[Federal Register: December 22, 2008 (Volume 73, Number 246)]
[Notices]
[Page 78372-78373]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr22de08-90]

[[Page 78372]]

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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Draft Guidance for Industry and Food and Drug Administration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availability of the draft guidance entitled ``Class II Special Controls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 This draft guidance document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 This draft guidance is not final nor is it in effect at this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this draft guidance before it begins work on a final version of the
guidance, submit written or electronic comments on the draft guidance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ADDRESSES:  Submit written requests for single copies of the FDA draft
guidance document entitled ``Class II Special Controls Guidance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    Submit written comments concerning this draft guidance to the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 dsmica@fda.hhs.gov 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

[[Page 78373]]

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