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, 15888-15889 [E7-6168]

Agencies

• Food and Drug Administration
• DEPARTMENT OF HEALTH AND HUMAN SERVICES

[Federal Register Volume 72, Number 63 (Tuesday, April 3, 2007)]
[Notices]
[Pages 15888-15889]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: E7-6168]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

Docket No. 2005D-0468


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 document entitled ``Class II Special 
Controls Guidance Document: Herpes Simplex Virus Types 1 and 2 
Serological Assays.'' This guidance document describes a means by which 
herpes simplex virus type 1 and 2 (HSV 1 and 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 
final rule reclassifying these devices from class III (premarket 
approval) into class II (special controls).

DATES: Submit written or electronic comments on agency guidances 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 (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 240-276-3151. See the SUPPLEMENTARY 
INFORMATION section for information on electronic access to the 
guidance.
    Submit written comments concerning this 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 https://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, 240-276-0496.

SUPPLEMENTARY INFORMATION:

I. Background

    In the Federal Register of January 9, 2006 (71 FR 1399), FDA 
published a proposed rule to reclassify herpes simplex virus types 1 
and 2 serological assays from class III (premarket approval) into class 
II (special controls). In addition, FDA issued a draft class II special 
controls guidance document entitled ``Class II Special Controls 
Guidance Document: Herpes Simplex Virus Types 1 and 2 Serological 
Assays'' to support the proposed reclassification. Herpes simplex virus 
types 1 and 2 serological assays are in vitro diagnostic devices that 
test for specific antibodies. In conjunction with other clinical 
laboratory findings, the detection of these HSV type 1 and/or 2 -
specific antibodies aids in the clinical laboratory diagnosis of an 
acute or past infection by HSV type 1 and/or 2. FDA did not receive any 
comments on the proposed reclassification. FDA is now identifying the 
guidance document entitled ``Class II Special Controls Guidance 
Document: Herpes Simplex Virus Types 1 and 2 Serological Assays'' as 
the guidance document that will serve as the special control for these 
devices.
    The guidance document provides a means by which herpes simplex 
virus types 1 and 2 serological assays may comply with the requirement 
of special controls for class II devices. Following the effective date 
of the final reclassification rule, any firm submitting a premarket 
notification (510(k)) for herpes simplex virus type 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 guidance is being issued consistent with FDA's good guidance 
practices regulation (21 CFR 10.115). The guidance represents the 
agency's current thinking on herpes simplex virus 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 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 e-mail request to dsmica@fda.hhs.gov to receive an 
electronic copy of the document or send a fax request to 240-276-3151 
to receive a hard copy. Please use the document number 1305 to identify 
the guidance you are requesting.
    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,

[[Page 15889]]

and other device-oriented information. The CDRH Web site may be 
accessed at https://www.fda.gov/cdrh. A search capability for all CDRH 
guidance documents is available at https://www.fda.gov/cdrh/
guidance.html. Guidance documents are also available on the Division of 
Dockets Management Internet site at https://www.fda.gov/ohrms/dockets.

IV. Paperwork Reduction Act of 1995

    This 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 part 807 subpart E have been 
approved under OMB Control No. 0910-0120; and the collections of 
information in 21 CFR part 801 and 21 CFR 809.10 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. The guidance and received comments may 
be seen in the Division of Dockets Management between 9 a.m. and 4 
p.m., Monday through Friday.

    Dated: March 23, 2007.
Linda S. Kahan,
Deputy Director, Center for Devices and Radiological Health.
[FR Doc. E7-6168 Filed 4-2-07; 8:45 am]
BILLING CODE 4160-01-S