Document ID: FDA-2009-D-0328-0001
Agency: fda
Document Type: Notice
Title: Guidance for Industry and Food and Drug Administration Staff; Class II Special Controls Guidance Document: Wound Dressing With Poly (Diallyl Dimethyl Ammonium Chloride) Additive; Availability
Posted Date: 2009-10-16T04:00Z

[Federal Register: October 16, 2009 (Volume 74, Number 199)]
[Notices]               
[Page 53269-53270]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr16oc09-81]                         

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2009-D-0328]

 
Guidance for Industry and Food and Drug Administration Staff; 
Class II Special Controls Guidance Document: Wound Dressing With Poly 
(Diallyl Dimethyl Ammonium Chloride) Additive; 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: Wound Dressing With Poly (Diallyl Dimethyl Ammonium 
Chloride) (pDADMAC) Additive.'' This guidance document describes a 
means by which wound dressing with Poly (diallyl dimethyl ammonium 
chloride) (pDADMAC) additive 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 wound dressing 
with pDADMAC additive into class II (special controls). This guidance 
document is being immediately implemented as the special control for 
wound dressing with pDADMAC additive, but it remains subject to comment 
in accordance with the agency's good guidance practices (GGPs).

DATES:  Submit written or electronic comments on the 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: Wound 
Dressing With Poly (Diallyl Dimethyl Ammonium Chloride) (pDADMAC) 
Additive'' to the Division of Small Manufacturers, International, and 
Consumer Assistance, Center for Devices and Radiological Health (CDRH), 
Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 66, rm. 
4613, Silver Spring, MD 20850. Send one self-addressed adhesive label 
to assist that office in processing your request, or fax your request 
to 301-847-8502. 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 http://www.regulations.gov. Identify comments with the docket number 
found in brackets in the heading of this document.

FOR FURTHER INFORMATION CONTACT:  Sam Arepalli, Center for Devices and 
Radiological Health (HFZ-410), Food and Drug Administration, 10903 New 
Hampshire Ave., Bldg. 66, rm. 3612, Silver Spring, MD 20993, 301-796-
6434.

SUPPLEMENTARY INFORMATION:

I. Background

    Elsewhere in this issue of the Federal Register, FDA is publishing 
a final rule classifying into class II (special controls) under section 
513(f)(2) of the Federal Food, Drug, and Cosmetic Act (the act) (21 
U.S.C. 360c(f)(2)). This guidance document will serve as the special 
control for wound dressing with pDADMAC additive. Section 513(f)(2) of 
the act provides that any person who submits a premarket notification 
under section 510(k) of the act (21 U.S.C. 360(k)) for a device that 
has not previously been classified may, within 30 days after receiving 
an order classifying the device in class III under section 513(f)(1) of 
the act, request FDA to classify the device under the criteria set 
forth in section 513(a)(1) of the act. FDA shall, within 60 days of 
receiving such a request, classify the device by written order. This 
classification shall be the initial classification of the device. 
Within 30 days after the issuance of an order classifying the device, 
FDA must publish a notice in the Federal Register announcing such 
classification. Because of the timeframes established by section 
513(f)(2) of the act, FDA has determined, under Sec.  10.115(g)(2) (21 
CFR 10.115(g)(2)), that it is not feasible to allow for public 
participation before issuing this guidance as a final guidance 
document. Thus, FDA is issuing this guidance document as a level 1 
guidance document that is immediately in effect. FDA will consider any 
comments that are received in response to this notice to determine 
whether to amend the guidance document.

II. Significance of Guidance

    This guidance is being issued consistent with FDA's GGPs regulation 
(Sec.  10.115). The guidance represents the agency's current thinking 
on wound dressings with pDADMAC additive. 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: Wound Dressing With Poly (Diallyl Dimethyl Ammonium Chloride) 
(pDADMAC) Additive,'' 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 1684 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 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 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 (the PRA) (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; and the collections of information in 21 CFR

[[Page 53270]]

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 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 2, 2009.
Jeffrey Shuren,
Acting Director, Center for Devices and Radiological Health.
[FR Doc. E9-24964 Filed 10-15-09; 8:45 am]

BILLING CODE 4160-01-S