[Federal Register Volume 66, Number 221 (Thursday, November 15, 2001)]
[Notices]
[Pages 57470-57471]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 01-28562]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket Nos. 00D-1557 and 00D-1558]


Medical Devices; Class II Special Controls Guidance Document: 
Indwelling Blood Gas Analyzers; Final Guidance for Industry and FDA; 
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: Indwelling Blood Gas Analyzers; Final Guidance for 
Industry and FDA.'' This guidance document describes the controls FDA 
believes will provide reasonable assurance of the safety and 
effectiveness of three anesthesiology devices. Elsewhere in this issue 
of the Federal Register, FDA is publishing a final rule reclassifying 
indwelling blood gas analyzers from class III to class II (special 
controls).

DATES: Submit written or electronic comments on the guidance at any 
time. General comments on agency guidance documents 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: Indwelling Blood Gas Analyzers; Final Guidance for 
Industry and FDA'' to the Division of Small Manufacturers, 
International, and Consumer Assistance (HFZ-220), Center for Devices 
and Radiological Health (CDRH), 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: Christy Foreman, Center for Devices 
and Radiological Health (HFZ-450), Food and Drug Administration, 9200

[[Page 57471]]

Corporate Blvd., Rockville, MD 20850, 301-443-8609.

SUPPLEMENTARY INFORMATION:

I. Background

    This guidance document was developed as a special controls guidance 
to support the reclassification of three anesthesiology devices from 
class III (premarket approval) to class II (special controls). The 
three devices are:
      Indwelling blood carbon dioxide partial pressure 
(Pco2) analyzer (21 CFR 868.1150),
      Indwelling blood hydrogen ion concentration (pH) analyzer 
(21 CFR 868.1170), and
      Indwelling blood oxygen partial pressure (Po2) 
analyzer (21 CFR 868.1200).
    The guidance document combines and supersedes the guidances 
entitled ``Guidance for Electrical Safety, Electromagnetic 
Compatibility and Mechanical Testing for Indwelling Blood Gas Analyzer 
Premarket Notification Submissions'' and ``Guidance for Indwelling 
Blood Gas Analyzer 510(k) Submissions'' which, in turn, incorporated 
the special controls listed separately in the March 15, 1999 (64 FR 
12774), proposal to reclassify these devices. In the Federal Register 
of November 22, 2000 (65 FR 70357), FDA announced the availability of 
the two guidance documents that were intended to serve as special 
controls and invited interested persons to comment on the guidances by 
February 20, 2001. In that same issue of the Federal Register (65 FR 
70325), FDA reopened the comment period for 90 days to allow comments 
regarding the proposed reclassification of the three anesthesiology 
devices from class III into class II. FDA received no comments on the 
proposed reclassification of the three devices.
    FDA received one comment on the document entitled ``Guidance for 
Indwelling Blood Gas Analyzer 510(k) Submissions'' that was proposed as 
a special control for the devices. The comment, submitted by Diametrics 
Medical Ltd., disagreed that all clinical studies should be designated 
``significant risk'' and be conducted under an investigational device 
exemption (IDE).
    FDA agrees with the comment and has modified the guidance. With the 
exception of devices employing new technology, studies of the device 
are nonsignificant risk. These nonsignificant risk studies are exempt 
from IDE requirements in accordance with Sec. 812.2(c)(2) (21 CFR 
812.2(c)(2)), but must be performed in accordance with parts 50 and 56 
(21 CFR parts 50 and 56). However, if the device employs new technology 
(i.e., technology different from that used in a legally marketed 
indwelling blood gas analyzers), FDA has determined that studies of 
this device are significant risk, as defined in 21 CFR 812.3(m)(4) and, 
therefore, do not qualify for the abbreviated requirements of Sec.  
812.2(b). In addition to the requirement of having an FDA-approved IDE, 
sponsors of such trials must comply with the regulations governing 
institutional review boards (part 56) and informed consent (part 50).
    Designation of this guidance as a special control means that 
manufacturers attempting to establish that their device is 
substantially equivalent to a predicate indwelling blood gas analyzer 
should demonstrate that the proposed device complies with either the 
specific recommendations of this guidance or some alternate control 
that provides equivalent assurance of safety and effectiveness.

II. Significance of Guidance

    This guidance document represents the agency's current thinking 
concerning indwelling blood gas analyzers. 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 applicable statute and regulations.
    The agency has adopted good guidance practices (GGPs) and published 
the final rule, which set forth the agency's regulations for the 
development, issuance, and use of guidance documents (21 CFR 10.115). 
This guidance document is issued as a level 2 guidance in accordance 
with the GGP regulations.

III. Electronic Access

    In order to receive ``Class II Special Controls Guidance Document: 
Indwelling Blood Gas Analyzers; Final 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 (1126) 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 the civil money penalty 
guidance documents package, 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. Comments

    Interested persons may submit to the Dockets Management Branch 
(address above) written or electronic comments regarding this guidance 
at any time. Submit two copies of any comments, except that individuals 
may submit one copy. Comments should 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: November 5, 2001.
Linda S. Kahan,
Deputy Director, Center for Devices and Radiological Health.
[FR Doc. 01-28562 Filed 11-14-01; 8:45 am]
BILLING CODE 4160-01-S