[Federal Register: January 9, 2006 (Volume 71, Number 5)]
[Notices]
[Page 1432-1433]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr09ja06-37]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. 2005D-0468]
Draft Guidance for Industry and Food and Drug Administration
Staff; Class II Special Controls Guidance Document: Herpes Simplex
Virus Types 1 and 2 Serological Assays; 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availability of the draft guidance entitled ``Class II Special Controls
Guidance Document: Herpes Simplex Virus Types 1 and 2 Serological
Assays.'' This draft guidance document
[[Page 1433]]
describes a means by which herpes simplex virus types 1 and/or 2 (HSV 1
and/or 2) serological assays may comply with the requirement of special
controls for class II devices. Elsewhere in this issue of the Federal
Register, FDA is publishing a proposed rule to reclassify these devices
from class III into class II (special controls).
DATES: Submit written or electronic comments on this draft guidance by
April 10, 2006.
ADDRESSES: Submit written requests for single copies on a 3.5''
diskette of the draft guidance document entitled ``Class II Special
Controls Guidance Document: Herpes Simplex Virus Types 1 and 2
Serological Assays'' 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Submit written comments concerning this draft guidance to the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: Sally Hojvat, Center for Devices and
Radiological Health (HFZ-440), Food and Drug Administration, 9200
Corporate Blvd., Rockville, MD 20850, 301-594-2096.
SUPPLEMENTARY INFORMATION:
I. Background
FDA developed this draft guidance document as a special control to
support the classification of in vitro diagnostic devices for the
laboratory diagnosis of herpes simplex virus (HSV) infection into class
II (special controls). HSV (types 1 and/or 2) serological assays are
intended for testing specimens from individuals who have signs and
symptoms of infection consistent with HSV 1 and/or 2; determining if an
individual has been previously infected with HSV 1 and/or 2; or
providing epidemiological information about these infections. The
detection of these antibodies aids in the clinical diagnosis of an
infection by HSV 1 and/or 2 in conjunction with other clinical
laboratory findings.
This draft guidance document identifies the classification
regulation and product codes for HSV 1 and/or 2 serological assays. In
addition, other sections of this guidance document list the risks to
health identified by FDA and describe measures that, if followed by
manufacturers and combined with the general controls, will generally
address the risks associated with these assays and lead to a timely
premarket notification (510(k)) review and clearance. This document
supplements other FDA documents regarding the specific content of a
premarket notification submission.
II. Significance of Guidance
This draft guidance is being issued consistent with FDA's good
guidance practices regulation (21 CFR 10.115). The draft guidance, when
finalized, will represent the agency's current thinking on class II
special controls for HSV 1 and/or 2 serological assays. 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: Herpes
Simplex Virus Types 1 and 2 Serological Assays'' by 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 (1305)
followed by the pound sign (). Follow the remaining voice
prompts to complete your request.
To receive ``Class II Special Controls Guidance Document: Herpes
Simplex Virus Types 1 and 2 Serological Assays,'' you may either send a
fax request to 301-443-8818 to receive a hard copy of the document, or
send an e-mail request to gwa@cdrh.fda.gov to receive a hard copy or an
electronic copy. Please use the document number (1305) to identify the
guidance you are requesting.
Persons interested in obtaining a copy of the draft 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 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 draft guidance refers to previously approved collections of
information found in FDA regulations. These collections of information
are subject to review by the Office of Management and Budget (OMB)
under the Paperwork Reduction Act of 1995 (44 U.S.C. 3501-3520). The
collections of information in 21 CFR 807.87 have been approved under
OMB Control No. 0910-0120; the collections of information in 21 CFR
801.109 have been approved under OMB Control No. 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. Comments received may be
seen in the Division of Dockets Management between 9 a.m. and 4 p.m.,
Monday through Friday.
Dated: December 21, 2005.
Linda S. Kahan,
Deputy Director, Center for Devices and Radiological Health.
[FR Doc. 06-174 Filed 1-6-06; 8:45 am]
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