Document ID: FDA-2009-D-0118-0001
Agency: fda
Document Type: Notice
Title: Guidances for Industry and Food and Drug Administration Staff; Class II Special Controls Guidance Documents: Respiratory Viral Panel Multiplex Nucleic Acid Assay; and Testing for Human Metapneumovirus Using Nucleic Acid Assays; and Testing for Detection and Differentiation of Influenza A Virus Subtypes Using Multiplex Nucleic Acid Assays; Availability
Posted Date: 2009-10-09T04:00Z

[Federal Register: October 9, 2009 (Volume 74, Number 195)]
[Notices]               
[Page 52244-52245]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr09oc09-73]                         

[[Page 52244]]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2009-D-0118]

 
Guidances for Industry and Food and Drug Administration Staff; 
Class II Special Controls Guidance Documents: Respiratory Viral Panel 
Multiplex Nucleic Acid Assay; and Testing for Human Metapneumovirus 
Using Nucleic Acid Assays; and Testing for Detection and 
Differentiation of Influenza A Virus Subtypes Using Multiplex Nucleic 
Acid 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 special controls guidance document entitled ``Class 
II Special Controls Guidance Document: Respiratory Viral Panel 
Multiplex Nucleic Acid Assay,'' and two companion special controls 
guidance documents entitled ``Class II Special Controls Guidance 
Document: Testing for Human Metapneumovirus (hMPV) Using Nucleic Acid 
Assays'' and ``Class II Special Controls Guidance Document: Testing for 
Detection and Differentiation of Influenza A Virus Subtypes Using 
Multiplex Nucleic Acid Assays.'' These guidance documents describe a 
means by which respiratory viral panel multiplex nucleic acid assays 
may comply with the requirement of special controls for class II 
devices. The guidance documents include recommendations for performance 
evaluation, labeling, and measures to address the effects of ancillary 
reagents (specific reagents required under instructions for use of the 
assay but not provided) on safety and effectiveness of the device. 
Elsewhere in this issue of the Federal Register, FDA is publishing a 
final rule codifying the classification of the respiratory viral panel 
multiplex nucleic acid assay into class II (special controls), and 
establishing these guidance documents as the special controls for those 
devices.

DATES:  Submit written or electronic comments on the 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 
documents entitled ``Class II Special Controls Guidance Document: 
Respiratory Viral Panel Multiplex Nucleic Acid Assay,'' ``Class II 
Special Controls Guidance Document: Testing for Human Metapneumovirus 
(hMPV) Using Nucleic Acid Assays,'' or ``Class II Special Controls 
Guidance Document: Testing for Detection and Differentiation of 
Influenza A Virus Subtypes Using Multiplex Nucleic Acid Assay'' 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. 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 written comments concerning these guidances 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.regulations.gov. Identify comments with the docket number 
found in brackets in the heading of this document.

FOR FURTHER INFORMATION CONTACT: Zivana Tezak, Center for Devices and 
Radiological Health, Food and Drug Administration, 10903 New Hampshire 
Ave., Bldg. 66, rm. 5550, Silver Spring, MD 20993, 301-796-6204.

SUPPLEMENTARY INFORMATION:

I. Background

    Elsewhere in this issue of the Federal Register, FDA is publishing 
a final rule codifying the classification of the respiratory viral 
panel multiplex nucleic acid assay into class II (special controls) 
under section 513(f)(2) of the Federal Food, Drug, and Cosmetic Act 
(the act) (21 U.S.C. 360c(f)(2)), and establishing these guidance 
documents as the special controls for respiratory viral panel multiplex 
nucleic acid assay devices classified under that regulation. Section 
513(f)(2) of the act provides that any person who submits a premarket 
notification under section 510(k) of the act (21 U.S.C. 360(k)) for a 
device that has not previously been classified may, within 30 days 
after receiving an order classifying the device in class III under 
section 513(f)(1), request FDA to classify the device under the 
criteria set forth in section 513(a)(1). FDA shall, within 60 days of 
receiving such a request, classify the device by written order. This 
classification shall be the initial classification of the device. 
Within 30 days after the issuance of an order classifying the device, 
FDA must publish a notice in the Federal Register announcing such 
classification.
    Under this authority, on January 3, 2008, FDA by order classified 
into class II, subject to these special control guidance documents, the 
Luminex Molecular Diagnostics, Inc., xTAG\TM\ RVP (Respiratory Viral 
Panel).

II. Significance of Special Controls Guidance Documents

    FDA believes that adherence to the recommendations described in 
these guidance documents, in addition to the general controls, will 
provide reasonable assurance of the safety and effectiveness of 
respiratory viral panel multiplex nucleic acid assays classified under 
Sec.  866.3080. In order to be classified as a class II device under 
Sec.  866.3080, an RVP device must comply with the requirement of 
special controls; manufacturers must address the issues requiring 
special controls as identified in the guidance documents, either by 
following the recommendations in the guidance documents or by some 
other means that provides equivalent assurances of safety and 
effectiveness.

III. Electronic Access

    Persons interested in obtaining a copy of any of the guidance 
documents may do so by using the Internet. To receive ``Class II 
Special Controls Guidance Document: Respiratory Viral Panel Multiplex 
Nucleic Acid Assay,'' (document number 1669); ``Class II Special 
Controls Guidance Document: Testing for Human Metapneumovirus (hMPV) 
Using Nucleic Acid Assays,'' (document number 1673); or ``Class II 
Special Controls Guidance Document: Testing for Detection and 
Differentiation of Influenza A Virus Subtypes Using Multiplex Nucleic 
Acid Assays,'' (document number 1672); 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 numbers shown in parentheses in the previous 
sentence 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, and other device-oriented 
information.

[[Page 52245]]

The CDRH Web site may be accessed at http://www.fda.gov/MedicalDevices/
default.htm. 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 on the Division of Dockets Management 
Internet site at http://www.regulations.gov.

IV. Paperwork Reduction Act of 1995

    Elsewhere in this issue of the Federal Register, FDA is publishing 
a final rule establishing as special controls for the respiratory viral 
panel multiplex nucleic acid assay the three guidance documents that 
are the subject of this notice. The preamble to that rule addresses the 
application of the Paperwork Reduction Act of 1995 (44 U.S.C. 3501-
3520) to the information collection provisions referenced in these 
guidance documents.

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. Revised comments may be seen in the 
Division of Dockets Management between 9 a.m. and 4 p.m., Monday 
through Friday.

    Dated: October 1, 2009.
Jeffrey Shuren,
Acting Director, Center for Devices and Radiological Health.
[FR Doc. E9-24431 Filed 10-8-09; 8:45 am]

BILLING CODE 4160-01-S