E7-3254. Draft Guidance for Industry and Food and Drug Administration Staff; Class II Special Controls Guidance Document; Oxygen Pressure Regulators and Oxygen Conserving Devices; Availability

AGENCY:

Food and Drug Administration, HHS.

ACTION:

Notice.

SUMMARY:

The Food and Drug Administration (FDA) is announcing the availability of a draft guidance for industry and FDA staff entitled “Class II Special Controls Guidance Document: Oxygen Pressure Regulators and Oxygen Conserving Devices.” The draft guidance document is intended to assist manufacturers in complying with minimum performance, testing, and labeling recommendations that are being proposed for these devices. Elsewhere in this issue of the Federal Register, FDA is publishing a proposed rule to reclassify pressure regulators for use with medical oxygen into class II, subject to special controls. The proposal would also establish separate identification classifications for both oxygen pressure regulators and oxygen conserving devices, and would make those oxygen conserving devices that incorporate a built-in oxygen pressure regulator subject to special controls. This draft guidance is not final nor is it in effect at this time.

DATES:

Submit written or electronic comments on the draft guidance by May 29, 2007.

ADDRESSES:

Submit written requests for single copies of the draft guidance document entitled “Class II Special Controls Guidance Document: Oxygen Pressure Regulators and Oxygen Conserving Devices” to the Division of Small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 two self-addressed adhesive labels to assist that office in processing your request, or fax your request to 1-800-638-2041. See the SUPPLEMENTARY INFORMATION section for electronic access to the draft guidance document. Submit written comments on the draft guidance to the Division of Dockets Management (HFA-305), Food and Drug Administration, 5630 Fishers Lane, rm. 101, Rockville, MD 20852.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:

Christy Foreman, Center for Devices and Radiological Health (HFZ-340), Food and Drug Administration, 2094 Gaither Rd., Rockville, MD 20850, 240-276-0120.

SUPPLEMENTARY INFORMATION:

I. Background

This draft guidance provides FDA's recommendations to manufacturers for labeling and for determining ignition sensitivity and fault tolerance for oxygen pressure regulators. These devices are intended to convert medical oxygen pressure from a high variable pressure to a lower, more constant working pressure. The device is affixed to a pressurized container of oxygen and the regulator controls the gas flow. These devices are currently regulated as class I devices. However, FDA has received reports of fires and explosions associated with the use of oxygen pressure regulators resulting in serious injury to a number of equipment operators, including one fatality. The draft guidance, if finalized, would serve as the special control for these devices. FDA believes that conformance with the draft special controls guidance, when combined with the general controls of the Federal Food, Drug, and Cosmetic Act (the act), would address the risks associated with oxygen pressure regulators and provide reasonable assurance of their safety and effectiveness.

The draft guidance would also serve as a special control for oxygen conserving devices with a built-in oxygen pressure regulator; a device type already classified into class II under the generic device type noncontinuous ventilator (21 CFR 868.5905). FDA believes that conformance with the draft special controls guidance, when combined with the general controls of the act, will provide reasonable assurance of the safety and effectiveness of oxygen conserving devices with a built-in oxygen pressure regulator.

In the Federal Register of May 27, 2003 (68 FR 30214), FDA announced its intention to reclassify oxygen pressure regulators in its semi-annual regulatory agenda. FDA received one comment supporting the establishment of a proposed rule to reclassify these devices.

II. Significance of the Guidance

This draft guidance is being issued consistent with FDA's good guidance practices regulation (21 CFR 10.115). The draft guidance, when finalized, will represent the agency's current thinking on oxygen pressure regulators and oxygen conserving devices with a built-in oxygen pressure regulator. It does not create or confer any rights for or on any person and would 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 draft guidance may do so by using the Internet. To receive “Class II Special Controls Guidance Document: Pressure Regulators For Use With Medical Oxygen and Oxygen Conserving Devices,” you may either send an e-mail request to [e-mail] to receive an electronic copy of the document, or send a fax request to 240-276-3151 to receive a hard copy. Please use the document number 1227 to identify the guidance you are requesting.

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 draft 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 (premarket notification procedures) have been approved under OMB Control number 0910-0120. The labeling statements that would be required by this regulation are “public disclosure[s] of information originally supplied by the Federal government to the recipient for the purpose of disclosure to the public * * *” (5 CFR 1320.3(c)(2)). Accordingly, FDA concludes that the labeling requirements in this proposed rule are not subject to review by OMB under the PRA.

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. The draft guidance and received comments may be seen in the Division of Dockets Management between 9 a.m. and 4 p.m., Monday through Friday.

Dated: February 8, 2007.

Linda S. Kahan,

Deputy Director, Center for Devices and Radiological Health.