[Federal Register Volume 65, Number 226 (Wednesday, November 22, 2000)]
[Notices]
[Pages 70357-70358]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 00-29840]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

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


Guidance Documents for Premarket Notification (510(k)) 
Submissions for Indwelling Blood Gas Analyzers; 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 two guidance documents. These two guidance documents 
are intended to serve as special controls for three devices that FDA 
has proposed previously to reclassify from class III (premarket 
approval) to class II (special controls). Elsewhere in this issue of 
the Federal Register, FDA is reopening the comment period on the 
proposed reclassification of the three devices. FDA is now inviting 
comment on these two guidance documents because they were not available 
for comment at the time of the publication of the proposed 
reclassification.

DATES: Submit written comments on the agency guidances by February 20, 
2001.

ADDRESSES: Submit written comments on the agency guidances 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 for the appropriate guidance document 
found in table 1. Submit written requests for single copies on a 3.5" 
diskette of one or both of these guidance documents to the Division of 
Small Manufacturers 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 documents.

FOR FURTHER INFORMATION CONTACT: Joseph M. Sheehan, Center for Devices 
and Radiological Health (HFZ-215), Food and Drug Administration, 1350 
Piccard Dr., Rockville, MD 20850, 301-827-2974.

SUPPLEMENTARY INFORMATION:

I. Background

    In the Federal Register of March 15, 1999 (64 FR 12774), FDA 
published a proposed rule to reclassify 38

[[Page 70358]]

preamendments class III devices into class II and to establish special 
controls for these devices. FDA invited interested persons to comment 
on the proposed rule by June 14, 1999. FDA received one request to 
reopen the comment period for six devices. The request noted that FDA 
had not made the guidance documents that were proposed as special 
controls for these six devices available for comment through FDA's good 
guidance practices (GGP's) (65 FR 56468, September 19, 2000). The 
request further noted that it was impossible to comment on the proposed 
reclassification without the guidance documents being available. 
Therefore, the requester asked that FDA extend the comment period until 
at least 90 days after the guidance documents are publicly available. 
FDA agreed with the request. FDA also identified three additional 
devices for which the agency had not issued the guidance documents 
proposed as special controls in accordance with the GGP policy. These 
three devices are the Indwelling Blood Carbon Dioxide Partial Pressure 
(P<INF>co2</INF>) Analyzer (21 CFR 868.1150), the Indwelling Blood 
Hydrogen Ion Concentration (pH) Analyzer (21 CFR 868.1170), and the 
Indwelling Blood Oxygen Partial Pressure (P<INF>02</INF>) Analyzer (21 
CFR 868.1200).
    The agency is announcing the availability of the two guidance 
documents (with separate docket numbers) for these three additional 
devices; the guidance documents, with their docket numbers, and Facts-
on-Demand (FOD) numbers are as follows:

                                                    Table 1.
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                    Name of Guidance                             Docket Number          Facts-on-Demand Number
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Guidance for Indwelling Blood Gas Analyzer 510(k)         00D-1557                    1126
 Submissions
Guidance for Electrical Safety, Electromagnetic           00D-1558                    1161
 Compatibility and Mechanical Testing for Indwelling
 Blood Gas Analyzer Premarket Notification Submissions
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II. Significance of Guidance Documents

    These guidance documents represent the agency's current thinking on 
premarket notifications for these devices. These guidance documents do 
not create or confer any rights for or on any person and do not operate 
to bind FDA or the public. An alternative approach may be used if such 
approach satisfies the applicable statute, regulations, or both. Under 
FDA's GGP policy, each of these guidance documents is a Level 2 
guidance.

III. Electronic Access

    In order to receive these guidance documents via your fax machine, 
call the CDRH FOD 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 listed above 
followed by the pound sign (#). Follow the remaining voice prompts to 
complete your request. Persons interested in obtaining a copy of these 
guidance documents may do so by 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 
access to the Internet. Updated on a regular basis, the CDRH home page 
includes these guidance documents, 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.

IV. Comments

    Interested persons may submit to the Dockets Management Branch 
(address above) written comments regarding these guidance documents by 
February 20, 2001. 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 for the guidance document as listed 
in table 1. If you wish to comment on more than one guidance document, 
please submit your comments separately for each guidance document. The 
guidance documents and received comments may be seen in the Dockets 
Management Branch between 9 a.m. and 4 p.m., Monday through Friday.

    Dated: October 31, 2000.
Linda S. Kahan,
Deputy Director for Regulations Policy, Center for Devices and 
Radiological Health.
[FR Doc. 00-29840 Filed 11-21-00; 8:45 am]
BILLING CODE 4160-01-F