[Federal Register: November 15, 2001 (Volume 66, Number 221)]
[Notices]
[Page 57470-57471]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr15no01-74]
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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