[Federal Register Volume 75, Number 187 (Tuesday, September 28, 2010)]
[Notices]
[Pages 59726-59727]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2010-23640]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2010-D-0428]
Draft Guidance for Industry and Food and Drug Administration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availability of the draft guidance entitled ``Class II Special Controls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 This draft guidance document describes a means by which the
herpes simplex virus (HSV) serological assay device type 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 designate this guidance as the class II special
control. This draft guidance is not final nor is it in effect at this
time.
DATES: Although you can comment on any guidance at any time (see 21 CFR
10.115(g)(5)), to ensure that the agency considers your comment of this
draft guidance before it begins work on the final version of the
guidance, submit either electronic or written comments on the draft
guidance by December 27, 2010.
ADDRESSES: Submit written requests for single copies of the draft
guidance document entitled ``Class II Special Controls Guidance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
[[Page 59727]]
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 20993-0002.
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Submit electronic comments on the draft guidance to http://www.regulations.gov.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 draft guidance document provides recommendations on the types
of information and data that FDA believes needs to be included in a
premarket notification 510(k) submission for 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 herpes simplex virus in serum. Additionally, some of the
assays consist of herpes simplex virus antisera conjugated with a
fluorescent dye (immunofluorescent assays) used to identify herpes
simplex virus directly from clinical specimens or tissue culture
isolates derived from clinical specimens. The identification aids in
the diagnosis of diseases caused by herpes simplex viruses 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 have revised the
existing guidance by rewriting the method comparison section and the
sample selection inclusion and exclusion criteria section. The
revisions defined and differentiated the required studies and the study
populations for the assessment of the safety and effectiveness of the
different types of HSV 1 and HSV 2 serological assays. Additionally, we
made several corrections and clarifications throughout the document to
ensure accuracy, consistency, and ease of reading. Elsewhere in this
issue of the Federal Register, FDA is proposing to designate this
guidance as the class II special control for HSV types 1 and 2
serological assays. If this classification rule is finalized, FDA
intends that this guidance document will serve as the special control
for this device.
Following the effective date of any final classification rule based
on this proposal, any firm submitting a premarket notification (510(k))
for HSV types 1 and 2 serological assays will need to address the
issues covered in the special controls guidance document. However, the
firm need only show that its device meets the recommendations of the
guidance document or in some other way provides equivalent assurances
of safety and effectiveness.
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 HSV types 1
and 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
Persons interested in obtaining a copy of the draft guidance may do
so by using the Internet. To receive ``Class II Special Controls
Guidance Document: Herpes Simplex Virus Types 1 and 2 Serological
Assays,'' you may either send an email 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. 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.
IV. Paperwork Reduction Act of 1995
This draft 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: September 16, 2010.
Leslie Kux,
Acting Assistant Commissioner for Policy.
[FR Doc. 2010-23640 Filed 9-27-10; 8:45 am]
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