Document ID: FDA-2010-D-0428-0003
Agency: fda
Document Type: Notice
Title: Guidance for Industry and Staff; Availability: Class II Special Controls Guidance Document, Herpes Simplex Virus Types 1 and 2 Serological Assays
Posted Date: 2011-08-09T04:00Z

[Federal Register Volume 76, Number 153 (Tuesday, August 9, 2011)]
[Notices]
[Pages 48870-48871]
From the Federal Register Online via the Government Printing 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 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.

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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