Document ID: FDA-2010-D-0515-0001
Agency: fda
Document Type: Notice
Title: Guidance for Industry and Food and Drug Administration Staff; Class II Special Controls Guidance: Non-Powered Suction Apparatus DeviceIntended for Negative Pressure Wound Therapy; Availability
Posted Date: 2010-11-17T05:00Z

[Federal Register Volume 75, Number 221 (Wednesday, November 17, 2010)]
[Notices]
[Pages 70271-70272]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2010-28872]

-----------------------------------------------------------------------

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2010-D-0515]

Guidance for Industry and Food and Drug Administration Staff; 
Class II Special Controls Guidance Document: Non-Powered Suction 
Apparatus Device Intended for Negative Pressure Wound Therapy; 
Availability

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

-----------------------------------------------------------------------

SUMMARY: The Food and Drug Administration (FDA) is announcing the 
availability of the guidance entitled ``Class II Special Controls 
Guidance Document: Non-powered Suction Apparatus Device Intended for 
Negative Pressure Wound Therapy (NPWT).'' This guidance document 
describes a means by which non-powered suction apparatus devices 
intended for NPWT 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 non-powered suction 
apparatus devices intended for NPWT into class II (special controls). 
This guidance document is immediately in effect as the special control 
for non-powered suction apparatus devices intended for NPWT, but it 
remains subject to comment in accordance with the Agency's good 
guidance practices (GGPs).

DATES: Submit either electronic or written 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: Non-
powered Suction Apparatus Device Intended for Negative Pressure Wound 
Therapy (NPWT)'' to the Division of Small Manufacturers, International, 
and Consumer Assistance, Center for Devices and Radiological Health, 
Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 66, rm. 
4617, Silver Spring, MD 20993-0002. Send one self-addressed adhesive 
label to assist that office in processing your request, or fax your 
request to 301-847-8149. See the SUPPLEMENTARY INFORMATION section for 
information on electronic access to the guidance.
    Submit electronic comments on the guidance to http://www.regulations.gov. Submit written comments to the Division of Dockets 
Management (HFA-305), Food and Drug Administration, 5630 Fishers Lane, 
Rm. 1061, Rockville, MD 20852. Identify comments with the docket number 
found in brackets in the heading of this document.

FOR FURTHER INFORMATION CONTACT: Jiyoung M. Dang, Center for Devices 
and Radiological Health, Food and Drug Administration, 10903 New 
Hampshire Ave., Bldg. 66, Rm. 3615, Silver Spring, MD 20993, 301-796-
5650.

SUPPLEMENTARY INFORMATION:

I. Background

    Elsewhere in this issue of the Federal Register, FDA is publishing 
a final rule classifying non-powered suction apparatus devices intended 
for negative pressure wound therapy into class II (special controls) 
under section 513(f)(2) of the Federal Food, Drug, and Cosmetic Act 
(the FD&C Act) (21 U.S.C. 360c(f)(2)). This guidance document will 
serve as the special control for non-powered suction apparatus devices 
intended for negative pressure wound therapy device. Section 513(f)(2) 
of the FD&C Act provides that any person who submits a premarket 
notification under section 510(k) of the FD&C 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 FD&C Act, request that FDA classify the device 
under the criteria set forth in section

[[Page 70272]]

513(a)(1) of the FD&C 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 FD&C 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. Therefore, 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 good guidance 
practices regulation (Sec.  10.115). The guidance represents the 
Agency's current thinking on non-powered suction apparatus devices 
intended for negative pressure wound therapy. 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. A search capability for all CDRH guidance documents 
is available at http://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/GuidanceDocuments/default.htm. Guidance 
documents are also available at http://www.regulations.gov. To receive 
``Class II Special Controls Guidance Document: Non-powered Suction 
Apparatus Device Intended for Negative Pressure Wound Therapy (NPWT),'' 
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 301-847-
8149 to receive a hard copy. Please use the document number 1701 to 
identify the guidance you are requesting.

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; 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 part 50 have been approved under OMB control 
number 0910-0586; the collections of information in 21 CFR 56 have been 
approved under OMB control number 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) either electronic or written comments regarding this 
document. It is only necessary to send one set of comments. It is no 
longer necessary to send two copies of mailed comments. Identify 
comments 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: November 10, 2010.
Nancy K. Stade,
Deputy Director for Policy, Center for Devices and Radiological Health.
[FR Doc. 2010-28872 Filed 11-16-10; 8:45 am]
BILLING CODE 4160-01-P