[Federal Register Volume 76, Number 153 (Tuesday, August 9, 2011)]
[Notices]
[Pages 48870-48871]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2011-20117]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2010-D-0428]
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 guidance entitled ``Class II Special Controls
Guidance Document: Herpes Simplex Virus Types 1 and 2 Serological
Assays.'' This guidance document describes a means by which the herpes
simplex virus types 1 and 2 serological assay device type may comply
with the requirement of special controls for class II devices.
DATES: Submit either electronic or written 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 of the 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, Center for
Devices and Radiological Health, Food and Drug Administration, 10903
New Hampshire Ave., Bldg. 66, rm. 4613, Silver Spring, MD 20993-
[[Page 48871]]
0002. Send one self-addressed adhesive label to assist that office in
processing your request, or fax your request to 301-847-8149. See the
SUPPLEMENTARY INFORMATION section for information on electronic access
to the guidance.
Submit electronic comments on the guidance to http://www.regulations.gov. Submit written comments to the Division of Dockets
Management (HFA-305), Food and Drug Administration, 5630 Fishers Lane,
rm. 1061, Rockville, MD 20852. Identify comments with the docket number
found in brackets in the heading of this document.
FOR FURTHER INFORMATION CONTACT: Haja Sittana El Mubarak, Center for
Devices and Radiological Health, Food and Drug Administration, 10903
New Hampshire Ave., Bldg. 66, rm. 5519, Silver Spring, MD 20993-0002,
301-796-6193.
SUPPLEMENTARY INFORMATION:
I. Background
This guidance document provides recommendations on the types of
information and data that FDA believes needs to be included in a 510(k)
for herpes simplex virus (HSV) types 1 and 2 serological assays. HSV
serological assays are devices that consist of antigens and antisera
used in various serological tests to identify antibodies to HSV in
serum. Additionally, some of the assays consist of HSV antisera
conjugated with a fluorescent dye (immunofluorescent assays) used to
identify HSV directly from clinical specimens or tissue culture
isolates derived from clinical specimens. The identification aids in
the diagnosis of diseases caused by HSVs and provides epidemiological
information on these diseases. Herpes simplex viral infections range
from common and mild lesions of the skin and mucous membranes to a
severe form of encephalitis (inflammation of the brain). Neonatal
herpes virus infections range from a mild infection to a severe
generalized disease with a fatal outcome. We revised the existing
guidance by rewriting the method comparison section and the sample
selection inclusion and exclusion criteria section. The revisions
define and differentiate the required studies and the study populations
for the assessment of the safety and effectiveness of the different
types of HSV types 1 and 2 serological assays. Additionally, the
revisions include several corrections and clarifications throughout the
document to ensure accuracy, consistency, and ease of reading. The
draft of this guidance issued on September 28, 2010 (75 FR 59726) and
the comment period closed on December 27, 2010. We received no comments
on the draft guidance. Elsewhere in this issue of the Federal Register,
FDA is finalizing the amendment of the special controls guidance
document and designating this guidance as the class II special control
for HSV types 1 and 2 serological assays. Following the effective date
in the final rule finalizing the amendment of the special controls
guidance document, this revised guidance document will serve as the
special control for this device and supersedes the guidance with the
same name that issued on April 3, 2007 (72 FR 15888).
II. Significance of Special Controls Guidance Document
FDA believes that adherence to the recommendations described in
this guidance document, in addition to the general controls, will
provide reasonable assurance of the safety and effectiveness of the HSV
types 1 and 2 serological assays classified under 21 CFR 866.3305. In
order to be classified as a class II device, HSV types 1 and 2
serological assays must comply with the requirements of special
controls; manufacturers must address the issues requiring special
controls as identified in the guidance document, either by following
the recommendations in the guidance document or by some other means
that provides equivalent assurances of safety and effectiveness.
III. Electronic Access
Persons interested in obtaining a copy of the guidance may do so by
using the Internet. A search capability for all CDRH guidance documents
is available at http://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/GuidanceDocuments/default.htm. Guidance
documents are also available at http://www.regulations.gov. To receive
``Class II Special Controls Guidance Document: Herpes Simplex Virus
Types 1 and 2 Serological Assays,'' you may either send an e-mail
request to [email protected] to receive an electronic copy of the
document or send a fax request to 301-847-8149 to receive a hard copy.
Please use the document number 1713 to identify the guidance you are
requesting.
IV. Paperwork Reduction Act
This guidance refers to previously approved collections of
information found in FDA regulations and guidance documents. 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 part
807, subpart E, have been approved under OMB control number 0910-0120;
the collections of information in 21 CFR part 812 have been approved
under OMB control number 0910-0078; and the collections of information
in 21 CFR part 801 and 21 CFR 809.10 have been approved under OMB
control number 0910-0485.
V. Comments
Interested persons may submit to the Division of Dockets Management
(see ADDRESSES), either electronic or written comments regarding this
document. It is only necessary to send one set of comments. It is no
longer necessary to send two copies of mailed comments. Identify
comments 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: August 3, 2011.
Nancy K. Stade,
Deputy Director for Policy, Center for Devices and Radiological Health.
[FR Doc. 2011-20117 Filed 8-8-11; 8:45 am]
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