Document ID: FDA-2009-D-0473-0001
Agency: fda
Document Type: Notice
Title: Guidance for Industry and Food and Drug Administration Staff; Class II Special Controls Guidance Document
Posted Date: 2009-10-21T04:00Z

[Federal Register: October 21, 2009 (Volume 74, Number 202)]
[Notices]               
[Page 54055-54056]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr21oc09-63]                         

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2009-D-0473]

 
Guidance for Industry and Food and Drug Administration Staff; 
Class II Special Controls Guidance Document: Cardiac Allograft Gene 
Expression Profiling Test Systems; 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: Cardiac Allograft Gene 
Expression Profiling Test Systems.'' This guidance document describes a 
means by which cardiac allograft gene expression profiling test systems 
may comply with the requirement of special controls for class II 
devices. It includes recommendations for validation of performance 
characteristics and recommendations for product labeling. Elsewhere in 
this issue of the Federal Register, FDA is publishing a final rule 
codifying the classification of cardiac allograft gene expression 
profiling test systems into class II (special controls), and 
establishing this guidance document as the special control for this 
device.

DATES: Submit 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: 
Cardiac Allograft Gene Expression Profiling Test Systems'' 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 to http://www.regulations.gov. 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. Identify comments with the docket number 
found in brackets in the heading of this document.

FOR FURTHER INFORMATION CONTACT: Kellie B. Kelm, Center for Devices and 
Radiological Health, Food and Drug Administration, 10903 New Hampshire 
Ave., Bldg. 66, rm. 5625, Silver Spring, MD 20993, 301-796-6145.

SUPPLEMENTARY INFORMATION:

I. Background

    Elsewhere in this issue of the Federal Register, FDA is publishing 
a final rule codifying the classification of cardiac allograft gene 
expression profiling test systems 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 this guidance 
document as the special control for cardiac allograft gene expression 
profiling test systems 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 August 26, 2008, FDA by order 
classified into class II, subject to this special control guidance 
document, the XDx AlloMap Test.

[[Page 54056]]

II. Significance of Special Controls Guidance Documents

    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 cardiac 
allograft gene expression profiling test systems classified under Sec.  
862.1163 (21 CFR 862.1163). In order to be classified as a class II 
device under Sec.  862.1163, a cardiac allograft gene expression 
profiling test system 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 the guidance may do so by 
using the Internet. To receive ``Class II Special Controls Guidance 
Document: Cardiac Allograft Gene Expression Profiling Test Systems,'' 
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 1686 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. 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 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 cardiac allograft 
gene expression profiling test systems the guidance document that is 
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 this 
guidance document.

V. Comments

    Interested persons may submit to the Division of Dockets Management 
(see ADDRESSES) electronic or written 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. Received comments may be seen in the 
Division of Dockets Management between 9 a.m. and 4 p.m., Monday 
through Friday.

    Dated: October 9, 2009.
Jeffrey Shuren,
Acting Director, Center for Devices and Radiological Health.
[FR Doc. E9-25313 Filed 10-20-09; 8:45 am]

BILLING CODE 4160-01-S