[Federal Register Volume 76, Number 79 (Monday, April 25, 2011)]
[Notices]
[Pages 22906-22907]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2011-9898]
-----------------------------------------------------------------------
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.
-----------------------------------------------------------------------
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]
BILLING CODE 4160-01-P