2011-20117. 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.

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 20993-0002. 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 [e-mail] 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.