[Federal Register: March 10, 2005 (Volume 70, Number 46)]
[Notices]
[Page 11987-11988]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr10mr05-90]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. 2005D-0069]
Guidance for Industry and Food and Drug Administration Staff;
Class II Special Controls Guidance Document: Instrumentation for
Clinical Multiplex Test Systems; 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 document entitled ``Class II Special
Controls Guidance Document: Instrumentation for Clinical Multiplex Test
Systems.'' This guidance document describes a means by which
instrumentation for clinical multiplex test systems may comply with the
requirements of special controls for class II devices. It includes
recommendations for validation of performance characteristics and
recommendations for product labeling. Elsewhere in this issue of the
Federal Register, FDA is publishing a final rule to classify
instrumentation for clinical multiplex test systems into class II
(special controls). This guidance document is immediately in effect as
the
[[Page 11988]]
special control for instrumentation for clinical multiplex test
systems, but it remains subject to comment in accordance with the
agency's good guidance practices (GGPs).
DATES: Submit written or electronic comments on this 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: Instrumentation for Clinical Multiplex Test
Systems'' 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 one self-addressed adhesive label 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 Division of
Dockets Management (HFA-305), Food and Drug Administration, 5630
Fishers Lane, rm. 1061, Rockville, MD 20852. Submit electronic comments
to http://frwebgate.access.gpo.gov/cgi-bin/leaving.cgi?from=leavingFR.html&log=linklog&to=http://www.fda.gov/dockets/ecomments. Identify comments with the
docket number found in brackets in the heading of this document.
FOR FURTHER INFORMATION CONTACT: Courtney Harper, Center for Devices
and Radiological Health (HFZ-440), Food and Drug Administration, 2098
Gaither Rd., Rockville, MD 20850, 301-594-1243, ext. 159.
SUPPLEMENTARY INFORMATION:
I. Background
Elsewhere in this issue of the Federal Register, FDA is publishing
a final rule classifying instrumentation for clinical multiplex test
systems into class II (special controls) under section 513(f)(2) of the
Federal Food, Drug, and Cosmetic Act (the act) (21 U.S.C. 360c(f)(2)).
This guidance document will serve as the special control for
instrumentation for clinical multiplex test systems.
Section 513(f)(2) of the act provides that any person who submits a
premarket notification under section 510(k) of the act (21 U.S.C.
360(k)) for a device that has not previously been classified may,
within 30 days after receiving written notice classifying the device in
class III under section 513(f)(1) of the act, request FDA to classify
the device under the criteria set forth in section 513(a)(1) of the
act. FDA shall, within 60 days of receiving such a request, classify
the device by written order. This classification shall be the initial
classification of the device. Within 30 days after the issuance of an
order classifying the device, FDA must publish a notice in the Federal
Register announcing such classification. Because of the timeframes
established by section 513(f)(2) of the act, FDA has determined, under
Sec. 10.115(g)(2) (21 CFR 10.115(g)(2)), that it is not feasible to
allow for public participation before issuing this guidance as a final
guidance document. Therefore, FDA is issuing this guidance document as
a level 1 guidance document that is immediately in effect. FDA will
consider any comments that are received in response to this notice to
determine whether to amend the guidance document.
II. Significance of Guidance
This guidance is being issued consistent with FDA's GGPs regulation
(Sec. 10.115). The guidance represents the agency's current thinking
on instrumentation for clinical multiplex test systems. 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
To receive ``Class II Special Controls Guidance Document:
Instrumentation for Clinical Multiplex Test Systems'' by fax, 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 (1546)
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 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 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 cleared submissions, approved applications, and
manufacturers' addresses), small manufacturer's assistance, information
on video conferencing and electronic submissions, Mammography Matters,
and other device-oriented information. The CDRH web site may be
accessed at http://frwebgate.access.gpo.gov/cgi-bin/leaving.cgi?from=leavingFR.html&log=linklog&to=http://www.fda.gov/cdrh A search capability for all CDRH guidance documents is available at http://frwebgate.access.gpo.gov/cgi-bin/leaving.cgi?from=leavingFR.html&log=linklog&to=http://www.fda.gov/cdrh/guidance.html.
Guidance documents are also available on the Division of
Dockets Management Internet site at http://frwebgate.access.gpo.gov/cgi-bin/leaving.cgi?from=leavingFR.html&log=linklog&to=http://www.fda.gov/ohrms/dockets.
IV. Paperwork Reduction Act of 1995
This guidance contains information collection provisions that are
subject to review by the Office of Management and Budget (OMB) under
the Paperwork Reduction Act of 1995 (the PRA) (44 U.S.C. 3501-3520) .
The collections of information addressed in the guidance document have
been approved by OMB in accordance with the PRA under the regulations
governing premarket notification submissions (21 CFR part 807, subpart
E, OMB control number 0910-0120). The labeling provisions addressed in
the guidance have been approved by OMB under OMB control number 0910-
0485.
V. Comments
Interested persons may submit to the Division of Dockets Management
(see ADDRESSES) written or electronic comments regarding this document.
Submit a single copy of electronic comments or two paper copies of any
mailed comments, except that individuals may submit one paper copy.
Comments are to be identified with the docket number found in brackets
in the heading of this document. Received comments may be seen in the
Division of Dockets Management between 9 a.m. and 4 p.m., Monday
through Friday.
Dated: March 2, 2005.
Linda S. Kahan,
Deputy Director, Center for Devices and Radiological Health.
[FR Doc. 05-4759 Filed 3-9-05; 8:45 am]
BILLING CODE 4160-01-S