
[Federal Register Volume 79, Number 151 (Wednesday, August 6, 2014)]
[Notices]
[Pages 45813-45814]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2014-18538]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

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


In Vitro Companion Diagnostic Devices; Guidance for Industry and 
FDA Staff; 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 guidance entitled ``In Vitro Companion Diagnostic 
Devices.'' This guidance is intended to assist sponsors who are 
planning to develop a therapeutic product for which the use of an in 
vitro companion diagnostic device is essential for the therapeutic 
product's safe and effective use as well as sponsors planning to 
develop an in vitro companion diagnostic device that is intended to be 
used with a corresponding therapeutic product.

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: An electronic copy of the guidance document is available for 
download from the Internet. See the SUPPLEMENTARY INFORMATION section 
for information on electronic access to the guidance. Submit written 
requests for a single hard copy of the guidance document entitled ``In 
Vitro Companion Diagnostic Devices'' to the Office of the Center 
Director, Guidance and Policy Development, Center for Devices and 
Radiological Health, Food and Drug Administration, 10903 New Hampshire 
Ave., Bldg. 66, Rm. 5431, Silver Spring, MD 20993-0002. Send one self-
addressed adhesive label to assist that office in processing your 
request. Alternatively, you may submit written requests for single 
copies of the 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, Center for Biologics 
Evaluation and Research, Food and Drug Administration, 10903 New 
Hampshire Ave., Bldg. 71, Rm. 3128, Silver Spring, MD 20993-0002. Send 
one self-addressed adhesive label to the office that you are ordering 
from to assist in processing your request.
    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: Elizabeth Mansfield, Center for 
Devices and Radiologic Health, Food and Drug Administration, 10903 New 
Hampshire Ave., Bldg. 66, Rm. 5676, Silver Spring, MD 20993-0002, 301-
796-4664; or Christopher Leptak, Center for Drug Evaluation and 
Research, Food and Drug Administration, Bldg. 22, Rm. 6462, 10903 New 
Hampshire Ave., Silver Spring, MD 20993-0002, 301-796-0017; or Stephen 
Ripley, Center for Biologics Evaluation and Research, Food and Drug 
Administration, 10903 New Hampshire Ave., Bldg. 71, Rm. 7301, Silver 
Spring, MD 20993-0002, 240-402-7911.

SUPPLEMENTARY INFORMATION:

I. Background

    The Food and Drug Administration (FDA) is announcing the 
availability of a guidance document for industry and FDA staff entitled 
``In Vitro Companion Diagnostic Devices.'' This guidance is intended to 
assist: (1) Sponsors who are planning to develop a therapeutic product 
(either a novel product or an existing product with a new indication) 
for which the use of an in vitro companion diagnostic device (or test) 
is essential for the therapeutic product's safe and effective use and 
(2) sponsors planning to develop an in vitro companion diagnostic 
device that is intended to be used with a corresponding therapeutic 
product. The guidance defines ``in vitro companion diagnostic device'' 
(also referred to as ``IVD companion diagnostic device'') and clarifies 
that in most circumstances, an IVD companion diagnostic device and its 
corresponding therapeutic product should be approved or cleared 
contemporaneously by FDA for the use indicated in the therapeutic 
product labeling.
    Diagnostic tests have been used for many years to enhance the use 
of therapeutic products. Tests are also used during therapeutic product 
development to obtain the data FDA uses to make regulatory 
determinations. After a therapeutic product is commercially available 
for use, health care professionals may use a relevant diagnostic test, 
for example, to select the appropriate therapy for a particular patient 
or to optimize a dosing regimen. Recently, the development of 
therapeutic products for which the use of a diagnostic test is 
essential for the products to meet their labeled safety and 
effectiveness claims has become more common. For example, such a test 
can identify appropriate subpopulations for treatment or identify 
populations who should not receive a particular treatment because of an 
increased risk of a serious side effect. These new technologies are 
making it increasingly possible to individualize, or personalize, 
medical therapy by identifying patients who are most likely to respond, 
or who are at varying degrees of risk for a particular side effect.
    FDA believes that use of an IVD companion diagnostic device with a 
therapeutic product raises important concerns about the safety and 
effectiveness of both the device and the therapeutic product. An 
erroneous test result could lead to withholding appropriate therapy or 
to administering inappropriate therapy. Health care professionals must 
be able to rely on information from IVD companion diagnostic devices to 
help make critical treatment decisions. FDA oversight of IVD companion 
diagnostic devices will help protect patients from treatment risks that 
could arise from IVD

[[Page 45814]]

companion diagnostic devices that have inadequate performance 
characteristics.
    When an appropriate scientific rationale supports such an approach, 
FDA encourages the joint development of therapeutic products and 
diagnostic devices that are essential for the safe and effective use of 
those therapeutic products. To facilitate the development and approval 
of therapeutic products that are intended for use with IVD companion 
diagnostic devices, as well as the development of the IVD companion 
diagnostic devices themselves, FDA is clarifying relevant policies 
related to these devices and products.
    In the Federal Register of July 14, 2011 (76 FR 41506), FDA 
announced the availability of the draft guidance document. Interested 
persons were invited to comment by October 12, 2011 (76 FR 51993). 
Thirty two sets of comments were received and reviewed by FDA. The 
guidance was updated to address comments where appropriate.

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 IVD 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 guidance may do so by 
downloading an electronic copy from the Internet. A search capability 
for all Center for Devices and Radiological Health guidance documents 
is available at http://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/GuidanceDocuments/default.htm, and a search 
capability for all CBER guidance documents is available at http://www.fda.gov/BiologicsBloodVaccines/GuidanceComplianceRegulatoryInformation/default.htm. Guidance documents 
are also available at http://www.regulations.gov. Persons unable to 
download an electronic copy of ``In Vitro Companion Diagnostic 
Devices,'' may send an email request to CDRH-Guidance@fda.hhs.gov to 
receive an electronic copy of the document. Please use the document 
number 1737 to identify the guidance you are requesting.

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 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 number 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 801 and 21 CFR 809.10 have been approved under 
OMB control number 0910-0485; and the collections of information in 21 
CFR 201.56 and 21 CR 201.57 have been approved under OMB control number 
0910-0572.

V. Comments

    Interested persons may submit either electronic comments regarding 
this document to http://www.regulations.gov or written comments to the 
Division of Dockets Management (see ADDRESSES). It is only necessary to 
send one set of 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, and will be posted to the docket at http://www.regulations.gov.

    Dated: July 30, 2014.
Leslie Kux,
Assistant Commissioner for Policy.
[FR Doc. 2014-18538 Filed 8-5-14; 8:45 am]
BILLING CODE 4164-01-P


