
[Federal Register Volume 76, Number 135 (Thursday, July 14, 2011)]
[Notices]
[Pages 41506-41507]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2011-17671]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2011-D-0215]


Draft Guidance for Industry and FDA Staff on In Vitro Companion 
Diagnostic Devices; 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availability of a draft guidance entitled ``In Vitro Companion 
Diagnostic Devices.'' This guidance is intended to assist sponsors 
planning to develop a therapeutic product that depends on the use of an 
in vitro companion diagnostic device for its safe and effective use or 
an in vitro diagnostic device that is intended for use with a 
corresponding therapeutic product and included in the instructions for 
use in the labeling of those products. This guidance defines in vitro 
companion diagnostic devices; explains the need for FDA oversight of 
companion diagnostic devices; clarifies that, in most circumstances, if 
use of a companion diagnostic device is essential for the safe and 
effective use of a therapeutic product, the diagnostic device and 
therapeutic product should be approved or cleared contemporaneously by 
FDA for the use indicated in the therapeutic product labeling; provides 
guidance for industry and FDA staff on possible premarket regulatory 
pathways and FDA's regulatory enforcement policy; and describes certain 
statutory and regulatory approval requirements relevant to therapeutic 
product labeling that stipulate concomitant use of a companion 
diagnostic device to ensure safety and effectiveness of the therapeutic 
product. This draft guidance is not final, nor is it in effect at this 
time.

DATES: Although you can comment on any guidance at any time (see 21 CFR 
10.115(g)(5)), to ensure that the Agency considers your comment on this 
draft guidance before it begins work on the final version of the 
guidance, submit either electronic or written comments on the draft 
guidance by September 12, 2011.

ADDRESSES: Submit written requests for single copies of the draft 
guidance document entitled ``In Vitro Companion Diagnostic Devices'' to 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 a fax request to 301-827-8149 to receive a 
hard copy. Alternatively, you may submit written requests for single 
copies of the draft guidance to the Division of Drug Information, 
Center for Drug Evaluation and Research, Food and Drug Administration, 
10903 New Hampshire Ave., Bldg. 51, rm. 2201, Silver Spring, MD 20993-
0002, or Office of Communication, Outreach and Development (HFM-40), 
1401 Rockville Pike, suite 200N, Rockville, MD 20852. Send one self-
addressed adhesive label to the office that you are ordering from to 
assist in processing your requests. See the SUPPLEMENTARY INFORMATION 
section for information on electronic access to the guidance.
    Submit electronic comments on the draft 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: Elizabeth Mansfield, Center for 
Devices and Radiologic Health, Food and Drug Administration, Bldg. 66, 
rm. 5676, 10903 New Hampshire Ave., Silver Spring, MD 20993, 301-796-
4664; or Christopher Leptak, Office of Translational Sciences, Center 
for Drug Evaluation and Research, Food and Drug Administration, Bldg. 
22, rm. 5102, 10903 New Hampshire Ave., Silver Spring, MD 20993, 301-
796-0017; or Stephen Ripley, Center for Biologics Evaluation and 
Research (HFM-17), Food and Drug Administration, 1401 Rockville Pike, 
suite 200N, Rockville, MD 20852, 301-827-6210.

SUPPLEMENTARY INFORMATION: 

I. Background

    The Food and Drug Administration (FDA) is announcing the 
availability of a draft guidance for industry and FDA staff entitled 
``In Vitro Companion Diagnostic Devices.'' This guidance is intended to 
provide assistance both to sponsors developing therapeutic products, 
which for purposes of this guidance includes therapeutic, preventive, 
or prophylactic drugs and biological products that depend on the use of 
and are labeled for use with an in vitro diagnostic device, and to 
sponsors of the companion diagnostics. This guidance defines 
``companion diagnostic device'' and clarifies that in most 
circumstances, if use of a companion diagnostic device is essential for 
the safe and effective use of a therapeutic product, the diagnostic 
device and therapeutic product should be approved or cleared 
contemporaneously by FDA for the use indicated in the therapeutic 
product labeling.
    Diagnostic tests have been employed for many years to enhance the 
use of therapeutic products. Recently, therapeutic products that depend 
on the use of a diagnostic test to meet their labeled safety and 
effectiveness claims have become more common. For example, a test could 
identify or limit appropriate populations for treatment or identify 
populations who should not receive a particular treatment because of

[[Page 41507]]

the increased risk of a serious side effect. Another reason for this 
increasing interest is the emergence of new technologies that are 
improving our ability to individualize, or personalize, medical therapy 
by identifying patients who are more likely to respond positively or 
negatively to treatment, or who are at lower risk for a particular side 
effect.
    When an appropriate scientific rationale supports such an approach, 
FDA encourages the development and use of therapeutic products that 
depend on the use of approved or cleared companion diagnostic devices, 
and the Agency has already approved/cleared several companion 
diagnostics for use with corresponding therapeutic products. FDA 
believes that use of a companion diagnostic with a therapeutic product 
raises important concerns about the safety and effectiveness of both 
the test and the therapeutic product. An erroneous test result could 
lead to withholding an appropriate therapy or to administering an 
inappropriate therapy. Healthcare professionals must be able to rely on 
information from companion diagnostic devices to help make critical 
treatment decisions. FDA oversight of companion diagnostics will 
protect patients from treatment risks that could arise from in vitro 
companion diagnostic devices that have inadequate performance 
characteristics. To facilitate the development and clearance or 
approval of therapeutic products that are intended for use with 
companion diagnostic devices, as well as the development of the 
companion diagnostics themselves, FDA is clarifying relevant policies 
related to these devices and products.

II. Significance of Guidance

    This draft guidance is being issued consistent with FDA's good 
guidance practices regulation (21 CFR 10.115). The draft guidance, when 
finalized, will represent the Agency's current thinking on companion 
diagnostic devices. 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 statutes and regulations.

III. Electronic Access

    Persons interested in obtaining a copy of the draft guidance may do 
so by using the Internet. A search capability for all CDRH guidance 
documents is available at http://www.fda.gov/MedicalDevices/DeviceRegulationsGuidance/GuidanceDocuments/_default.htm. Guidance 
documents are also available at http://www.regulations.gov. To receive 
``In Vitro Companion Diagnostic Devices'', 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 1737 to identify the guidance you are 
requesting.

IV. Paperwork Reduction Act of 1995

    This draft 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 314 have been approved 
under OMB control number 0910-0001; the collections of information in 
21 CFR Part 312 have been approved under OMB control number 0910-0014; 
the collections of information in 21 CFR Part 601 have been approved 
under OMB control number 0910-0338; the collections of information in 
21 CFR Part 814, subparts B and E, have been approved under OMB Control 
No. 0910-0231; the collections of information in 21 CFR Part 812 have 
been approved under OMB control number 0910-0078; the collections of 
information in 21 CFR Part 801 and 21 CFR 809.10 have been approved 
under OMB Control No. 0910-0485; and the collections of information in 
21 CFR 201.56 and 21 CR 201.57 have been approved under OMB control 
number 0910-572.

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: July 8, 2011.
 Nancy K. Stade,
 Deputy Director for Policy, Center for Devices and Radiological 
Health.
[FR Doc. 2011-17671 Filed 7-12-11; 8:45 am]
BILLING CODE 4160-01-P


