[Federal Register Volume 70, Number 214 (Monday, November 7, 2005)]
[Notices]
[Pages 67489-67490]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 05-22069]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. 2005G-0367]


Guidance for Industry and Food and Drug Administration Staff; 
Class II Special Controls Guidance Document: Low Energy Ultrasound 
Wound Cleaner; 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: Low Energy Ultrasound Wound Cleaner.'' This guidance 
document has been developed as a special control guidance document to 
support the classification of the low energy ultrasound wound cleaner 
into class II (special controls). The device is intended for the 
cleaning and maintenance debridement of wounds. This guidance document 
describes a means by which the low energy ultrasound wound cleaner 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 the low energy ultrasound wound cleaner into 
class II (special controls). The guidance document is immediately in 
effect as the special control for the low energy ultrasound wound 
cleaner, but it remains subject to comment in accordance with the 
agency's good guidance practices (GGPs).

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 on a 
3.5 diskette of the guidance document entitled ``Class II 
Special Controls Guidance Document: Low Energy Ultrasound Wound 
Cleaner'' 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 301-443-8818. 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.fda.gov/dockets/ecomments. Identify comments with the 
docket number found in brackets in the heading of this document.

FOR FURTHER INFORMATION CONTACT: David B. Berkowitz, Center for Devices 
and Radiological Health (HFZ-410), Food and Drug Administration, 9200 
Corporate Blvd., Rockville, MD 20850, 301-594-3090, ext. 152.

SUPPLEMENTARY INFORMATION:

I. Background

    The guidance document ``Class II Special Controls Guidance 
Document: Low Energy Ultrasound Wound Cleaner'' has been developed as a

[[Page 67490]]

special control guidance document to support the classification of the 
low energy ultrasound wound cleaner into class II (special controls). 
This device is intended for the cleaning and maintenance debridement of 
wounds. On April 29, 2004, Celleration, Inc., submitted a petition 
requesting classification of the Celleration MIST Therapy System\TM\ 
under section 513(f)(2) of the Federal Food, Drug, and Cosmetic Act 
(the act) (21 U.S.C. 360c(f)(2)).
    Elsewhere in this issue of the Federal Register, FDA is publishing 
a final rule classifying the low energy ultrasound wound cleaner into 
class II (special controls) under section 513(f)(2) of the act. This 
guidance document will serve as the special control for the low energy 
ultrasound wound cleaner device. 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 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 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 GGPs regulation 
in Sec.  10.115. The guidance represents the agency's current thinking 
on the low energy ultrasound wound cleaner for the cleaning and 
maintenance debridement of wounds. 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

    To receive ``Class II Special Controls Guidance Document: Low 
Energy Ultrasound Wound Cleaner'' by fax, call the CDRH Facts-On-Demand 
system at 800-899-0381 or 301-827-0111 from a touch-tone telephone. 
Press 1 to enter the system. At the second voice prompt, press 1 to 
order a document. Enter the document number 1302 followed by the pound 
sign (). Follow the remaining voice prompts to complete your 
request.
    Persons interested in obtaining a copy of the guidance may also do 
so by using the Internet. 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 on the Division of Dockets 
Management Internet site at http://www.fda.gov/ohrms/dockets.

IV. Paperwork Reduction Act of 1995

    This guidance contains information collection provisions that are 
subject to review by the Office of Management and Budget (OMB) under 
the Paperwork Reduction Act of 1995 (the PRA) (44 USC 3501-3520). The 
collections of information addressed in the guidance document have been 
approved by OMB in accordance with 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 5, 2005.
Linda S. Kahan,
Deputy Director, Center for Devices and Radiological Health.
[FR Doc. 05-22069 Filed 11-4-05; 8:45 am]
BILLING CODE 4160-01-S