Document ID: FDA-2006-D-0094-0003
Agency: fda
Document Type: Notice
Title: Guidance for Industry and Food and Drug Administration Staff; Availability: Class II Special Controls Guidance Document: Topical Oxygen Chamber for Extremities
Posted Date: 2011-04-25T04:00Z

[Federal Register Volume 76, Number 79 (Monday, April 25, 2011)]
[Notices]
[Pages 22906-22907]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2011-9898]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2006-D-0094]

Guidance for Industry and Food and Drug Administration Staff; 
Class II Special Controls Guidance Document: Topical Oxygen Chamber for 
Extremities; 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: Topical Oxygen Chamber for Extremities.'' This 
guidance document was developed as a special control to support the 
reclassification of the topical oxygen chamber for extremities (TOCE) 
from class III (premarket approval) into class II (special controls). 
This guidance document describes a means by which manufacturers of TOCE 
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 reclassifying these devices from class III 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: 
Topical Oxygen Chamber for Extremities,'' 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 http://www.regulations.gov. Identify comments with the docket number 
found in brackets in the heading of this document.

FOR FURTHER INFORMATION CONTACT: Charles N. Durfor, 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

    In the Federal Register of April 6, 2006 (71 FR 17390), FDA's 
Center for Devices and Radiological Health (CDRH) published a proposed 
rule to reclassify the TOCE device type from class III (premarket 
approval) into class II (special controls) after reviewing current 
technological and scientific developments. To support the 
reclassification, CDRH issued a draft class II special controls 
guidance document entitled ``Class II Special Controls Guidance 
Document: Topical Oxygen Chamber for Extremities'' (71 FR 17476). 
Interested persons were invited to comment on the proposed rule and 
guidance by July 5, 2006. FDA received 11 comments on the proposed 
rule. The comments received discussed academic literature, clinical 
experiences, and patient outcomes that support the proposed 
reclassification's determinations of the safety and effectiveness of 
the TOCE device. The comments did not recommend any changes to the 
proposed regulation.
    FDA is now identifying the guidance document entitled ``Class II 
Special Controls Guidance Document: Topical Oxygen Chamber for 
Extremities'' as the special control for these devices. This guidance 
document provides a means by which manufacturers of TOCE devices may 
comply with the requirement of special controls for class II devices. 
Following the effective date of the final reclassification rule, any 
manufacturer submitting a premarket notification submission under 
section 510(k) of the Federal Food, Drug, and Cosmetic Act (the FD&C 
act) (21 U.S.C. 360(k)) for a TOCE device will need to address the 
issues covered in the special controls guidance document. However, the 
manufacturer need only show that its device meets the recommendations 
in the guidance document or in some other way provides equivalent 
assurances of safety and effectiveness.

II. Significance of Special Controls Guidance

    FDA believes that adherence to the recommendations described in 
this guidance document, in addition to the general controls, will 
provide reasonable assurance of the safety and effectiveness of TOCE 
classified under Sec.  878.5650 (21 CFR 878.5650). The final rule 
establishing this guidance document as a special control will be 
effective May 25, 2011. Following the effective date of the final rule, 
TOCE classified under Sec.  878.5650 must comply with the requirement 
of special controls; manufacturers must address the issues requiring 
special controls as identified in the guidance, either by following the 
recommendations in the guidance or by some other means that provides 
equivalent assurances of safety and effectiveness.

III. Electronic Access

    Persons with access to the Internet may obtain the document at 
either http://www.fda.gov/RegulatoryInformation/Guidances/default.htm 
or http://www.regulation.gov. Always access an FDA guidance document by 
using FDA's Web site listed previously to find the most current version 
of the guidance.

IV. Paperwork Reduction Act of 1995

    This guidance refers to previously approved collections of 
information found in FDA regulations. These collections of information 
were subject to review by the Office of Management and Budget (OMB) 
under the Paperwork Reduction Act of 1995 (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 801 have been approved under OMB control 
number 0910-0485; 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; and the collections of information in 21 CFR parts 50 
and

[[Page 22907]]

56 have been approved under OMB control number 0910-0130.

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: April 19, 2011.
Leslie Kux,
Acting Assistant Commissioner for Policy.
[FR Doc. 2011-9898 Filed 4-22-11; 8:45 am]
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