Guidance for Industry and Food and Drug Administration Staff; “Class II Special Controls Guidance Document: Absorbable Poly(hydroxybutyrate) Surgical Suture Produced by Recombinant DNA Technology;” Availability, 43282 [E7-15063]

Agencies

• Food and Drug Administration
• DEPARTMENT OF HEALTH AND HUMAN SERVICES

[Federal Register Volume 72, Number 149 (Friday, August 3, 2007)]
[Notices]
[Page 43282]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: E7-15063]



[[Page 43282]]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. 2007D-0268]


Guidance for Industry and Food and Drug Administration Staff; 
``Class II Special Controls Guidance Document: Absorbable 
Poly(hydroxybutyrate) Surgical Suture Produced by Recombinant DNA 
Technology;'' 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 entitled ``Class II Special Controls 
Guidance Document: Absorbable Poly(hydroxybutyrate) Surgical Suture 
Produced by Recombinant DNA Technology.'' This guidance document 
describes a means by which the absorbable poly(hydroxybutyrate) 
surgical suture produced by recombinant deoxyribonucleic acid (DNA) 
technology 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 classify these device types into class II 
(special controls).

DATES: Submit written or electronic comments on this guidance at any 
time. 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: 
Absorbable Poly(hydroxybutyrate) Surgical Suture Produced by 
Recombinant DNA Technology'' 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 https://www.fda.gov/dockets/ecomments. Identify comments with the 
docket number found in brackets in the heading of this document.

FOR FURTHER INFORMATION CONTACT: Nada O. Hanafi, Center for Devices and 
Radiological Health (HFZ-410), Food and Drug Administration, 9200 
Corporate Blvd., Rockville, MD 20850, 240-276-3555.

SUPPLEMENTARY INFORMATION:

I. Background

    This guidance describes a means by which the absorbable 
poly(hydroxybutyrate) surgical suture produced by recombinant DNA 
technology may comply with the requirement of special controls for 
class II devices. An absorbable poly(hydroxybutyrate) surgical suture 
is an absorbable surgical suture made of material isolated from 
prokaryotic cells produced by recombinant DNA technology. The device is 
intended for use in general soft tissue approximation and ligation. 
This guidance describes FDA's recommendations regarding physical and 
performance characteristics, biocompatibility, sterility, expiration 
dating, and labeling.

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 absorbable poly(hydroxybutyrate) surgical 
sutures produced by recombinant DNA technology. 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 guidance may do so by 
using the Internet. To receive ``Class II Special Controls Guidance 
Document: Absorbable Poly(hydroxybutyrate) Surgical Suture Produced by 
Recombinant DNA Technology,'' 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 1629 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 https://www.fda.gov/
cdrh. A search capability for all CDRH guidance documents is available 
at https://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 (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; the collections of 
information in 21 CFR part 820 have been approved under OMB control 
number 0910-0073; the collections of information in 21 CFR part 812 
have been approved under OMB control number 0910-0078; the collections 
of information in 21 CFR parts 56 and 50 have been approved under OMB 
control number 0910-0014.

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: July 23, 2007.
Linda S. Kahan,
Deputy Director, Center for Devices and Radiological Health.
[FR Doc. E7-15063 Filed 8-2-07; 8:45 am]
BILLING CODE 4160-01-S