[Federal Register: October 31, 2006 (Volume 71, Number 210)]
[Notices]
[Page 63774-63775]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr31oc06-64]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. 2006D-0363]
Draft Guidance for Industry and Food and Drug Administration
Staff; Class II Special Controls Guidance Document: Absorbable
Hemostatic 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availability of the draft guidance entitled ``Class II Special Controls
Guidance Document: Absorbable Hemostatic Device.'' The draft guidance
describes a means by which the absorbable hemostatic device 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 reclassify the absorbable hemostatic device from class
III (premarket approval) into class II (special controls). This draft
guidance is not final, nor is it being implemented at this time.
DATES: Submit written or electronic comments on this draft guidance by
January 29, 2007.
ADDRESSES: Submit written requests for single copies of the draft
guidance document entitled ``Class II Special Controls Guidance
Document: Absorbable Hemostatic 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Submit written comments concerning this draft guidance to the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://frwebgate.access.gpo.gov/cgi-bin/leaving.cgi?from=leavingFR.html&log=linklog&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: David Krause, Center for Devices and
Radiological Health (HFZ-410), Food and Drug Administration, 9200
Corporate Blvd., Rockville, MD 20850, 301-594-3090, ext. 141.
SUPPLEMENTARY INFORMATION:
I. Background
Absorbable hemostatic devices are primarily applied during surgical
procedures in order to control bleeding that is not readily controlled
via conventional means, such as cautery or ligation. At other times, an
absorbable hemostatic device may be applied due to the inaccessibility
of a site to conventional hemostatic methods.
On July 24, 2003, the General and Plastic Surgery Devices Panel
considered the types of information the agency should include in a
class II special controls guidance document for the absorbable
hemostatic device and recommended that the device be reclassified from
class III into class II. FDA considered the Panel's recommendations,
and elsewhere in this issue of the Federal Register, is proposing to
reclassify the absorbable hemostatic device into class II. If this
reclassification 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 reclassification rule
based on this proposal, any firm submitting a premarket notification
(510(k)) for an absorbable hemostatic device would 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
absorbable hemostatic device. 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 the draft guidance document
entitled ``Class II Special Controls Document: Absorbable Hemostatic
Device,'' 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
[[Page 63775]]
document number 1558 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 submissions, 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://frwebgate.access.gpo.gov/cgi-bin/leaving.cgi?from=leavingFR.html&log=linklog&to=http://www.fda.gov/cdrh A search capability for all CDRH guidance documents is available at http://frwebgate.access.gpo.gov/cgi-bin/leaving.cgi?from=leavingFR.html&log=linklog&to=http://www.fda.gov/cdrh/.
guidance.html. Guidance documents are also available on the Division of
Dockets Management Internet site at http://frwebgate.access.gpo.gov/cgi-bin/leaving.cgi?from=leavingFR.html&log=linklog&to=http://www.fda.gov/ohrms/dockets.
IV. Paperwork Reduction Act of 1995
This draft guidance contains information collection provisions that
are subject to the 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
document 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). The labeling provisions
addressed in the guidance have been approved by OMB 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: October 19, 2006.
Linda S. Kahan,
Deputy Director, Center for Devices and Radiological Health.
[FR Doc. E6-18318 Filed 10-30-06; 8:45 am]
BILLING CODE 4160-01-S