[Federal Register Volume 71, Number 210 (Tuesday, October 31, 2006)]
[Notices]
[Pages 63774-63775]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: E6-18318]


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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Draft Guidance for Industry and Food and Drug Administration 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availability of the draft guidance entitled ``Class II Special Controls 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 The draft guidance 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 This draft 
guidance is not final, nor is it being implemented at this time.

DATES:  Submit written or electronic comments on this draft guidance by 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ADDRESSES:  Submit written requests for single copies of the draft 
guidance document entitled ``Class II Special Controls Guidance 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    Submit written comments concerning this draft guidance to the 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://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 [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

[[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://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 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