02-31441. Medical Devices; Class II Special Controls Guidance Document: Cutaneous Carbon Dioxide and Oxygen Monitors; 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: Cutaneous Carbon Dioxide (PcCO₂) and Oxygen (PcO₂) Monitors; Guidance for Industry and FDA.” This guidance document describes a means by which PcCO₂ monitors and the PcO₂ monitor 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 the PcCO₂ monitor from class II (performance standards) into class II (special controls), the PcO₂ monitor for an infant patient who is not under gas anesthesia from class II (performance standards) into class II (special controls), and the PcO₂ monitor for all other uses from class III (premarket approval) into class II (special controls).

DATES:

Submit written or electronic comments on this guidance at any time. General comments on agency guidances 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: Cutaneous Carbon Dioxide (PcCO2) and Oxygen (PcO2) Monitors; Guidance for Industry and FDA” 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 301-443-8818. See the SUPPLEMENTARY INFORMATION section for information on electronic access to the guidance.

Submit written comments concerning this guidance to the Dockets Management Branch (HFA-305), Food and Drug Administration, 5630 Fishers Lane, rm. 1061, Rockville, MD 20852. Comments should be identified with the docket number found in brackets in the heading of this document. Submit electronic comments to http://www.fda.gov/​dockets/​ecomments.

FOR FURTHER INFORMATION CONTACT:

William A. Noe, Center for Devices and Radiological Health (HFZ-450), Food and Drug Administration, 9200 Corporate Blvd., Rockville, MD 20850, 301-443-8609, ext. 174.

SUPPLEMENTARY INFORMATION:

I. Background

In the Federal Register of February 12, 2002 (67 FR 6444), FDA published a proposed rule to reclassify the PcCO₂ monitor from class II (performance standards) into class II (special controls), the PcO₂ monitor for an infant patient who is not under gas anesthesia from class II (performance standards) into class II (special controls), and the PcO₂ monitor for all other uses from class III (premarket approval) into class II (special controls).

In the Federal Register of February 12, 2002 (67 FR 6544), FDA also identified the document “Class II Special Controls Guidance Document: Cutaneous Carbon Dioxide (PcCO₂) and Oxygen (PcO₂) Monitors; Draft Guidance for Industry and FDA” as the special control capable of providing reasonable assurance of safety and effectiveness for these devices. This guidance document describes a means by which PcCO₂ and PcO₂ monitors may comply with the requirement of special controls for class II devices. Designation of this guidance document as a special control means that a manufacturer attempting to establish that its device is substantially equivalent to a predicate class II monitor must demonstrate that the proposed device complies with either the specific recommendations of this guidance or some alternate control that provides equivalent assurances of safety and effectiveness.

Interested persons were invited to comment on the draft guidance by May 13, 2002. FDA received two comments on the draft guidance document. The comments, from manufacturers, suggested that the draft guidance does not cite current voluntary consensus standards applicable to the devices subject to this guidance. FDA considered the comments and revised the guidance where we believe appropriate. FDA also clarified the description of the risks to health, in order to relate the risks more directly to the recommended mitigation measures.

II. Significance of Guidance

This guidance is being issued consistent with FDA's good guidance practices regulation (21 CFR 10.115). The guidance represents the agency's current thinking on “Class II Special Controls Guidance Document: Cutaneous Carbon Dioxide (PcCO₂) and Oxygen (PcO₂) Monitors; Guidance for Industry and FDA.” 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

In order to receive “Class II Special Controls Guidance Document: Cutaneous Carbon Dioxide (PcCO₂) and Oxygen (PcO₂) Monitors; Guidance for Industry and FDA,” via your fax machine, 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 (1335) 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 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 manufacturers' assistance, information on video conferencing and electronic submissions, Mammography Matters, and other device-oriented information. The CDRH home page 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 Dockets Management Branch Internet site at http://www.fda.gov/​ohrms/​dockets.

IV. Paperwork Reduction Act of 1995

The premarket notification information collections addressed in the guidance have been approved by the Office of Management and Budget (OMB) under the Paperwork Reduction Act of 1995 (PRA) under OMB control number 0910-0120. The labeling provisions addressed in the guidance have been approved by OMB under the PRA under OMB control number 0910-0485.

V. Comments

Interested persons may submit to the Dockets Management Branch (see ADDRESSES) written or electronic comments on the guidance. Two copies of any comments are to be submitted, except that individuals may submit one copy. Comments are to be identified with the docket number found in brackets in the heading of this document. The guidance document and received comments may be seen in the Dockets Management Branch between 9 a.m. and 4 p.m., Monday through Friday.

Dated: December 2, 2002.

Linda S. Kahan,

Deputy Director, Center for Devices and Radiological Health.