Guidance for Industry and Food and Drug Administration Staff; In Vitro Diagnostic Devices to Detect Influenza A Viruses: Labeling and Regulatory Path; Availability

AGENCY:

Food and Drug Administration, HHS.

ACTION:

Notice.

SUMMARY:

The Food and Drug Administration (FDA) is announcing the availability of the guidance entitled “In Vitro Diagnostic Devices to Detect Influenza A Viruses: Labeling and Regulatory Path.” FDA is issuing this guidance to inform industry and agency staff of steps that are needed to ensure the safe and effective use of in vitro diagnostic (IVD) devices intended for use in the detection of influenza A (or A/B) virus directly from human specimens. FDA is taking this action because of recent significant public health concerns associated with emergence of an avian influenza A virus strain as a human pathogen in Southeast Asia. This guidance document describes recommendations for fulfilling labeling requirements applicable to all IVDs intended to generally detect influenza A (or A/B) virus directly from human specimens, and outlines the premarket regulatory path for new or modified devices intended to generally detect influenza A virus, or to detect and differentiate, specific novel influenza A viruses infecting humans. This guidance document is immediately in effect, but it remains subject to comment in accordance with the agency's good guidance practices.

DATES:

Submit written or electronic comments on this guidance at any time.

ADDRESSES:

Submit written requests for single copies of the guidance document entitled “In Vitro Diagnostic Devices to Detect Influenza A Viruses: Labeling and Regulatory Path” 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 301-443-8818. 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 http://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

The spread of the influenza A H5N1 virus within bird species, along with sporadic transmission to humans, has heightened awareness of the potential for a novel influenza A virus to cause a pandemic in humans. Novel influenza A viruses are new or re-emergent human strains of influenza A that cause cases or clusters of human disease, as opposed to those human strains commonly circulating that cause seasonal influenza and to which human populations have residual or limited immunity (either by vaccination or previous infection). All of the influenza A (or A/B) devices cleared by FDA under 21 CFR 866.3330 before February 3, 2006, are designed to generally detect influenza A viruses in human respiratory specimens (e.g., washes, aspirates, and swabs). None of these devices is designed or intended to detect a specific influenza A virus, or to detect and differentiate one specific influenza A virus from another (e.g., H5N1 from H3N2). For devices cleared on the basis of performance characteristics established when only influenza A/H3 and A/H1 viruses were circulating, there is no evidence that the devices would reliably detect novel influenza A viruses from human respiratory samples. Also, these testing devices are not intended to detect and differentiate a specific human-infecting novel influenza A virus. FDA is making this guidance document immediately available because prior public participation is not feasible given the national and global public health threat of pandemic influenza. At this time public health officials are expediting plans to prepare for and respond to this threat. Immediate implementation of this guidance is part of this preparedness effort as it clarifies the role of in vitro diagnostic devices for the detection and/or differentiation of novel influenza A viruses.

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 labeling and regulatory path for in vitro diagnostic devices to detect influenza A viruses. 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

To receive “In Vitro Diagnostic Devices to Detect Influenza A Viruses: Labeling and Regulatory Path” by fax machine, call the CDRH Facts-On-Demand system at 800-899-0381 or 301-827-0111 from a touch-tone telephone. Press 1 to enter the system. At the second voice prompt, press 1 to order a document. Enter the document number 1549 followed by the pound sign (#). Follow the remaining voice prompts to complete your request.

Persons interested in obtaining a copy of the guidance may also do so by using the Internet. 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, and other device-oriented information. The CDRH web site may be accessed at http://www.fda.gov/cdrh . A search capability for all CDRH guidance documents is available at http://www. fda.gov/cdrh/guidance.html. Guidance documents are also available on the Division of Dockets Management Internet site at http://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 809 have been approved under OMB Control No. 0910-0485; the collections of information in 21 CFR part 807 have been approved under OMB Control No. 0910-0120; the collections of information in 21 CFR part 812 have been approved under OMB Control No. 0910-0078.

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 copy. Comments are to be identified with the docket number found in brackets in the heading of this document. Comments received may be seen in the Division of Dockets Management between 9 a.m. and 4 p.m., Monday through Friday.