[Federal Register Volume 76, Number 135 (Thursday, July 14, 2011)]
[Notices]
[Pages 41506-41507]
From the Federal Register Online via the Government Publishing 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Draft Guidance for Industry and FDA Staff on In Vitro Companion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availability of a draft guidance entitled ``In Vitro Companion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 This draft guidance is not final, nor is it in effect at this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draft guidance before it begins work on the final version of the
guidance, submit either electronic or written comments on the draft
guidance by September 12, 2011.
ADDRESSES: Submit written requests for single copies of the draft
guidance document entitled ``In Vitro Companion Diagnostic Devices'' to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 [email protected] 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