Document ID: FDA-2010-D-0428-0001
Agency: fda
Document Type: Notice
Title: Draft Guidance for Industry and Food and Drug Administration Staff: Class II Special Controls Guidance Document; Herpes Simplex Virus Types 1 and 2 Serological Assays;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
Posted Date: 2010-09-28T04:00Z

[Federal Register: September 28, 2010 (Volume 75, Number 187)]
[Notices]               
[Page 59726-59727]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr28se10-80]                         

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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Draft Guidance for Industry and Food and Drug Administration 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availability of the draft guidance entitled ``Class II Special Controls 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 This draft guidance document describes a means by which the 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 This draft guidance is not final nor is it in effect at this 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draft guidance before it begins work on the final version of the 
guidance, submit either electronic or written comments on the draft 
guidance by December 27, 2010.

ADDRESSES: Submit written requests for single copies of the draft 
guidance document entitled ``Class II Special Controls Guidance 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 dsmica@fda.hhs.gov 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]
BILLING CODE 4160-01-S