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Guidance for Industry and Food and Drug Administration Staff; Class II Special Controls Guidance Document: Topical Oxygen Chamber for Extremities; Availability

Document Details

Information about this document as published in the Federal Register.

Published Document

This document has been published in the Federal Register. Use the PDF linked in the document sidebar for the official electronic format.

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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.

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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.

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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 § 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 § 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 Start Printed Page 2290756 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.

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Dated: April 19, 2011.

Leslie Kux,

Acting Assistant Commissioner for Policy.

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[FR Doc. 2011-9898 Filed 4-22-11; 8:45 am]

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