[Federal Register: November 22, 2000 (Volume 65, Number 226)]
[Notices]
[Page 70357-70358]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr22no00-71]
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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
(Pco2) Analyzer (21 CFR 868.1150), the Indwelling Blood
Hydrogen Ion Concentration (pH) Analyzer (21 CFR 868.1170), and the
Indwelling Blood Oxygen Partial Pressure (P02) 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://frwebgate.access.gpo.gov/cgi-bin/leaving.cgi?from=leavingFR.html&log=linklog&to=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