Investigational In Vitro Diagnostics Used in Clinical Investigations of Therapeutic Products; Draft Guidance for Industry, Food and Drug Administration Staff, Sponsors, and Institutional Review Boards; Availability, 60022-60024 [2017-27155]
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Federal Register / Vol. 82, No. 241 / Monday, December 18, 2017 / Notices
FOR FURTHER INFORMATION CONTACT:
daltland on DSKBBV9HB2PROD with NOTICES
Michael Pacanowski, Center for Drug
Evaluation and Research, Food and
Drug Administration, 10903 New
Hampshire Ave., Bldg. 71, Rm. 7301,
Silver Spring, MD 20993–0002, 301–
796–3919; 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
FDA is announcing the availability of
a draft guidance for industry entitled
‘‘Developing Targeted Therapies in
Low-Frequency Molecular Subsets of a
Disease.’’ This guidance is intended to
assist sponsors in designing drug
development programs to generate the
evidence needed to demonstrate efficacy
of a targeted therapy across subsets of
patients with different underlying
molecular alterations within a disease,
where some molecular alterations may
occur at low frequencies.
In recent years, advances in our
understanding of the molecular
pathology of many diseases have led to
the development of targeted therapies.
Although variability in drug response
has long been recognized in drug
development, targeted therapies present
new challenges in addressing the
heterogeneity in drug response because
the pharmacological effect of a targeted
therapy is often related to a particular
molecular alteration (e.g., a mutation,
gene fusion, epigenetic change, etc.).
Many clinically defined diseases are
caused by a range of different molecular
alterations, some of which may occur at
low frequencies, that impact a common
protein or pathway involved in the
disease pathogenesis. In a population of
patients with the same clinical disease,
the heterogeneity in the molecular
etiology may result in different
responses to a particular therapy.
However, certain targeted therapies may
be effective in multiple groups of
patients that have different underlying
molecular alterations. Therefore, FDA is
providing guidance on the type and
quantity of evidence that can
demonstrate efficacy across molecular
subsets within a disease.
This guidance addresses the following
important topics in evaluating the
benefits and risks of targeted
therapeutics within a disease where
some molecular alterations may occur at
low frequencies:
• Identification of patients for inclusion
in clinical trials
• Interpretation of study results and
generalizability of findings
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17:53 Dec 15, 2017
Jkt 244001
• Benefit-risk determination and
therapeutic product labeling
• Refining the indicated population
after the initial approval
In addition to comments on the
general content of the draft guidance,
FDA requests input on whether the
principles described for grouping
molecular subsets for clinical trial
enrollment should be limited to diseases
with low-frequency molecular
alterations or whether they could be
broadly applicable to all targeted
therapies.
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 current thinking of FDA
on ‘‘Developing Targeted Therapies in
Low-Frequency Molecular Subsets of a
Disease.’’ It does not establish any rights
for any person and is not binding on
FDA or the public. You can use an
alternative approach if it satisfies the
requirements of the applicable statutes
and regulations. This guidance is not
subject to Executive Order 12866.
II. Electronic Access
Persons with access to the internet
may obtain the draft guidance at either
https://www.fda.gov/Drugs/Guidance
ComplianceRegulatoryInformation/
Guidances/default.htm, https://
www.fda.gov/BiologicsBloodVaccines/
GuidanceComplianceRegulatory
Information/Guidances/default.htm, or
https://www.regulations.gov.
Dated: December 12, 2017.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2017–27156 Filed 12–15–17; 8:45 am]
BILLING CODE 4164–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2017–N–6356]
Investigational In Vitro Diagnostics
Used in Clinical Investigations of
Therapeutic Products; Draft Guidance
for Industry, Food and Drug
Administration Staff, Sponsors, and
Institutional Review Boards;
Availability
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Notice of availability.
The Food and Drug
Administration (FDA or Agency) is
announcing the availability of the draft
guidance entitled ‘‘Investigational IVDs
Used in Clinical Investigations of
SUMMARY:
PO 00000
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Fmt 4703
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Therapeutic Products.’’ This draft
guidance is intended to assist sponsors
of clinical investigations of therapeutic
products that also include
investigational in vitro diagnostics
(IVDs) and institutional review boards
(IRBs) that review such investigations in
complying with the Investigational
Device Exemption (IDE) regulation. This
draft guidance is also intended to assist
FDA staff participating in the review of
these investigations. This draft guidance
is not final nor is it in effect at this time.
DATES: Submit either electronic or
written comments on the draft guidance
by March 19, 2018 to ensure that the
Agency considers your comment on this
draft guidance before it begins work on
the final version of the guidance.
ADDRESSES: You may submit comments
on any guidance at any time as follows:
Electronic Submissions
Submit electronic comments in the
following way:
• Federal eRulemaking Portal:
https://www.regulations.gov. Follow the
instructions for submitting comments.
Comments submitted electronically,
including attachments, to https://
www.regulations.gov will be posted to
the docket unchanged. Because your
comment will be made public, you are
solely responsible for ensuring that your
comment does not include any
confidential information that you or a
third party may not wish to be posted,
such as medical information, your or
anyone else’s Social Security number, or
confidential business information, such
as a manufacturing process. Please note
that if you include your name, contact
information, or other information that
identifies you in the body of your
comments, that information will be
posted on https://www.regulations.gov.
• If you want to submit a comment
with confidential information that you
do not wish to be made available to the
public, submit the comment as a
written/paper submission and in the
manner detailed (see ‘‘Written/Paper
Submissions’’ and ‘‘Instructions’’).
Written/Paper Submissions
Submit written/paper submissions as
follows:
• Mail/Hand delivery/Courier (for
written/paper submissions): Dockets
Management Staff (HFA–305), Food and
Drug Administration, 5630 Fishers
Lane, Rm. 1061, Rockville, MD 20852.
• For written/paper comments
submitted to the Dockets Management
Staff, FDA will post your comment, as
well as any attachments, except for
information submitted, marked and
identified, as confidential, if submitted
as detailed in ‘‘Instructions.’’
E:\FR\FM\18DEN1.SGM
18DEN1
daltland on DSKBBV9HB2PROD with NOTICES
Federal Register / Vol. 82, No. 241 / Monday, December 18, 2017 / Notices
Instructions: All submissions received
must include the Docket No. FDA–
2017–N–6356 for ‘‘Investigational IVDs
Used in Clinical Investigations of
Therapeutic Products.’’ Received
comments will be placed in the docket
and, except for those submitted as
‘‘Confidential Submissions,’’ publicly
viewable at https://www.regulations.gov
or at the Dockets Management Staff
between 9 a.m. and 4 p.m., Monday
through Friday.
• Confidential Submissions—To
submit a comment with confidential
information that you do not wish to be
made publicly available, submit your
comments only as a written/paper
submission. You should submit two
copies total. One copy will include the
information you claim to be confidential
with a heading or cover note that states
‘‘THIS DOCUMENT CONTAINS
CONFIDENTIAL INFORMATION.’’ The
Agency will review this copy, including
the claimed confidential information, in
its consideration of comments. The
second copy, which will have the
claimed confidential information
redacted/blacked out, will be available
for public viewing and posted on
https://www.regulations.gov. Submit
both copies to the Dockets Management
Staff. If you do not wish your name and
contact information to be made publicly
available, you can provide this
information on the cover sheet and not
in the body of your comments and you
must identify this information as
‘‘confidential.’’ Any information marked
as ‘‘confidential’’ will not be disclosed
except in accordance with 21 CFR 10.20
and other applicable disclosure law. For
more information about FDA’s posting
of comments to public dockets, see 80
FR 56469, September 18, 2015, or access
the information at: https://www.gpo.gov/
fdsys/pkg/FR-2015-09-18/pdf/201523389.pdf.
Docket: For access to the docket to
read background documents or the
electronic and written/paper comments
received, go to https://
www.regulations.gov and insert the
docket number, found in brackets in the
heading of this document, into the
‘‘Search’’ box and follow the prompts
and/or go to the Dockets Management
Staff, 5630 Fishers Lane, Rm. 1061,
Rockville, MD 20852.
You may submit comments on any
guidance at any time (see 21 CFR
10.115(g)(5)).
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 draft guidance
VerDate Sep<11>2014
17:53 Dec 15, 2017
Jkt 244001
document entitled ‘‘Investigational IVDs
Used in Clinical Investigations of
Therapeutic Products’’ 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; or the 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
assist that office in processing your
request.
FOR FURTHER INFORMATION CONTACT:
David Litwack, Center for Devices and
Radiological Health, Food and Drug
Administration, 10903 New Hampshire
Ave., Bldg. 66, Rm. 4548, Silver Spring,
MD 20993–0002, 301–796–6697 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, 240–402–
7911.
SUPPLEMENTARY INFORMATION:
I. Background
This draft guidance is intended to
assist sponsors of clinical investigations
of therapeutic products that also include
investigational IVDs and IRBs that
review such investigations in complying
with the IDE regulation. This draft
guidance is also intended to assist FDA
staff participating in the review of these
investigations.
This draft guidance describes when
the IDE regulation may apply to certain
clinical investigations of therapeutic
products; certain regulatory
requirements that sponsors should be
aware of as they develop and conduct
such investigations; recommendations
for determining the risk of
investigational IVD use in a therapeutic
product investigation; recommendations
for IRBs in reviewing such
investigations; and recommendations
for content to provide in an IDE
application, when required.
Additionally, FDA is seeking feedback
on the policy in the draft guidance
regarding the need for an IDE for a
significant risk study of an
investigational IVD device with a
therapeutic product under an IND.
Specifically, FDA requests stakeholder
perspectives on whether it would be
beneficial to allow submission of all IDE
components to an IND rather than
require both an IDE and an IND. If such
an approach would be beneficial, please
PO 00000
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Fmt 4703
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60023
identify any specific circumstances, for
example a companion diagnostic and
the associated therapeutic product,
where efficiency may be improved or
burden may be decreased, or both,
without compromising patient safety.
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 investigational IVDs used in clinical
investigations of therapeutic products. It
does not establish any rights for any
person and is not binding on FDA or the
public. You can use an alternative
approach if it satisfies the requirements
of the applicable statutes and
regulations. This guidance is not subject
to Executive Order 12866.
III. Electronic Access
Persons interested in obtaining a copy
of the draft 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 https://www.fda.gov/MedicalDevices/
DeviceRegulationandGuidance/
GuidanceDocuments/default.htm. This
draft guidance is also available at
https://www.regulations.gov. Persons
unable to download an electronic copy
of ‘‘Investigational IVDs Used in
Clinical Investigations of Therapeutic
Products’’ may send an email request to
CDRH-Guidance@fda.hhs.gov to receive
an electronic copy of the document.
Please use the document number
1400025 to identify the guidance you
are requesting.
IV. Paperwork Reduction Act of 1995
This draft guidance refers to currently
approved collections of information.
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 809 have
been approved under OMB control
number 0910–0485; the collections of
information in parts 50 and 56 have
been approved under OMB control
number 0910–0755; the collections of
information in 21 CFR 56.115 have been
approved under OMB control number
0910–0130; the collections of
information in 21 CFR 50.23 have been
approved under OMB control number
0910–0586; 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 820 have
E:\FR\FM\18DEN1.SGM
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Federal Register / Vol. 82, No. 241 / Monday, December 18, 2017 / Notices
been approved under OMB control
number 0910–0073; the collections of
information in 21 CFR part 312 have
been approved under OMB control
number 0910–0014; and the collections
of information in 21 CFR part 314 have
been approved under OMB control
number 0910–0001. The collections of
information in the guidance document
entitled ‘‘Requests for Feedback on
Medical Device Submissions: The PreSubmission Program and Meetings with
Food and Drug Administration Staff’’
have been approved under OMB control
number 0910–0756.
Dated: December 12, 2017.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2017–27155 Filed 12–15–17; 8:45 am]
BILLING CODE 4164–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2017–D–6765]
Replacement Reagent and Instrument
Family Policy for In Vitro Diagnostic
Devices; Draft Guidance for Industry
and Food and Drug Administration
Staff; Availability
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Notice of availability.
The Food and Drug
Administration (FDA or Agency) is
announcing the availability of the draft
guidance entitled ‘‘Replacement Reagent
and Instrument Family Policy for In
Vitro Diagnostic Devices.’’ FDA is
issuing this draft guidance document to
update and clarify the policy for a
manufacturer’s application of an assay
that was previously cleared for use
based on performance characteristics
with a specified instrument, to an
additional instrument that was
previously cleared or that is a member
of an instrument family from which
another member has been previously
cleared. When finalized, this document
will supersede ‘‘Replacement Reagent
and Instrument Family Policy,’’ issued
on December 11, 2003. This draft
guidance is not final nor is it in effect
at this time.
DATES: Submit either electronic or
written comments on the draft guidance
by March 19, 2018 to ensure that the
Agency considers your comment on this
draft guidance before it begins work on
the final version of the guidance.
ADDRESSES: You may submit comments
on any guidances at any time as follows:
daltland on DSKBBV9HB2PROD with NOTICES
SUMMARY:
VerDate Sep<11>2014
17:53 Dec 15, 2017
Jkt 244001
Electronic Submissions
Submit electronic comments in the
following way:
• Federal eRulemaking Portal:
https://www.regulations.gov. Follow the
instructions for submitting comments.
Comments submitted electronically,
including attachments, to https://
www.regulations.gov will be posted to
the docket unchanged. Because your
comment will be made public, you are
solely responsible for ensuring that your
comment does not include any
confidential information that you or a
third party may not wish to be posted,
such as medical information, your or
anyone else’s Social Security number, or
confidential business information, such
as a manufacturing process. Please note
that if you include your name, contact
information, or other information that
identifies you in the body of your
comments, that information will be
posted on https://www.regulations.gov.
• If you want to submit a comment
with confidential information that you
do not wish to be made available to the
public, submit the comment as a
written/paper submission and in the
manner detailed (see ‘‘Written/Paper
Submissions’’ and ‘‘Instructions’’).
Written/Paper Submissions
Submit written/paper submissions as
follows:
• Mail/Hand delivery/Courier (for
written/paper submissions): Dockets
Management Staff (HFA–305), Food and
Drug Administration, 5630 Fishers
Lane, Rm. 1061, Rockville, MD 20852.
• For written/paper comments
submitted to the Dockets Management
Staff, FDA will post your comment, as
well as any attachments, except for
information submitted, marked and
identified, as confidential, if submitted
as detailed in ‘‘Instructions.’’
Instructions: All submissions received
must include the Docket No. FDA–
2017–D–6765 for ‘‘Replacement Reagent
and Instrument Family Policy for In
Vitro Diagnostic Devices; Draft
Guidance for Industry and Food and
Drug Administration Staff.’’ Received
comments will be placed in the docket
and, except for those submitted as
‘‘Confidential Submissions,’’ publicly
viewable at https://www.regulations.gov
or at the Dockets Management Staff
between 9 a.m. and 4 p.m., Monday
through Friday.
• Confidential Submissions—To
submit a comment with confidential
information that you do not wish to be
made publicly available, submit your
comments only as a written/paper
submission. You should submit two
copies total. One copy will include the
PO 00000
Frm 00025
Fmt 4703
Sfmt 4703
information you claim to be confidential
with a heading or cover note that states
‘‘THIS DOCUMENT CONTAINS
CONFIDENTIAL INFORMATION.’’ The
Agency will review this copy, including
the claimed confidential information, in
its consideration of comments. The
second copy, which will have the
claimed confidential information
redacted/blacked out, will be available
for public viewing and posted on
https://www.regulations.gov. Submit
both copies to the Dockets Management
Staff. If you do not wish your name and
contact information to be made publicly
available, you can provide this
information on the cover sheet and not
in the body of your comments and you
must identify this information as
‘‘confidential.’’ Any information marked
as ‘‘confidential’’ will not be disclosed
except in accordance with 21 CFR 10.20
and other applicable disclosure law. For
more information about FDA’s posting
of comments to public dockets, see 80
FR 56469, September 18, 2015, or access
the information at: https://www.gpo.gov/
fdsys/pkg/FR-2015-09-18/pdf/201523389.pdf.
Docket: For access to the docket to
read background documents or the
electronic and written/paper comments
received, go to https://
www.regulations.gov and insert the
docket number, found in brackets in the
heading of this document, into the
‘‘Search’’ box and follow the prompts
and/or go to the Dockets Management
Staff, 5630 Fishers Lane, Rm. 1061,
Rockville, MD 20852.
You may submit comments on any
guidance at any time (see 21 CFR
10.115(g)(5)).
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 draft guidance
document entitled ‘‘Replacement
Reagent and Instrument Family Policy
for In Vitro 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.
Avis
Danishefsky, Center for Devices and
Radiological Health, Food and Drug
Administration, 10903 New Hampshire
Ave., Bldg. 66, Rm. 5620, Silver Spring,
MD 20993–0002, 301–796–6142.
FOR FURTHER INFORMATION CONTACT:
E:\FR\FM\18DEN1.SGM
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]]>Agencies
[Federal Register Volume 82, Number 241 (Monday, December 18, 2017)]
[Notices]
[Pages 60022-60024]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2017-27155]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2017-N-6356]
Investigational In Vitro Diagnostics Used in Clinical
Investigations of Therapeutic Products; Draft Guidance for Industry,
Food and Drug Administration Staff, Sponsors, and Institutional Review
Boards; Availability
AGENCY: Food and Drug Administration, HHS.
ACTION: Notice of availability.
-----------------------------------------------------------------------
SUMMARY: The Food and Drug Administration (FDA or Agency) is announcing
the availability of the draft guidance entitled ``Investigational IVDs
Used in Clinical Investigations of Therapeutic Products.'' This draft
guidance is intended to assist sponsors of clinical investigations of
therapeutic products that also include investigational in vitro
diagnostics (IVDs) and institutional review boards (IRBs) that review
such investigations in complying with the Investigational Device
Exemption (IDE) regulation. This draft guidance is also intended to
assist FDA staff participating in the review of these investigations.
This draft guidance is not final nor is it in effect at this time.
DATES: Submit either electronic or written comments on the draft
guidance by March 19, 2018 to ensure that the Agency considers your
comment on this draft guidance before it begins work on the final
version of the guidance.
ADDRESSES: You may submit comments on any guidance at any time as
follows:
Electronic Submissions
Submit electronic comments in the following way:
Federal eRulemaking Portal: https://www.regulations.gov.
Follow the instructions for submitting comments. Comments submitted
electronically, including attachments, to https://www.regulations.gov
will be posted to the docket unchanged. Because your comment will be
made public, you are solely responsible for ensuring that your comment
does not include any confidential information that you or a third party
may not wish to be posted, such as medical information, your or anyone
else's Social Security number, or confidential business information,
such as a manufacturing process. Please note that if you include your
name, contact information, or other information that identifies you in
the body of your comments, that information will be posted on https://www.regulations.gov.
If you want to submit a comment with confidential
information that you do not wish to be made available to the public,
submit the comment as a written/paper submission and in the manner
detailed (see ``Written/Paper Submissions'' and ``Instructions'').
Written/Paper Submissions
Submit written/paper submissions as follows:
Mail/Hand delivery/Courier (for written/paper
submissions): Dockets Management Staff (HFA-305), Food and Drug
Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852.
For written/paper comments submitted to the Dockets
Management Staff, FDA will post your comment, as well as any
attachments, except for information submitted, marked and identified,
as confidential, if submitted as detailed in ``Instructions.''
[[Page 60023]]
Instructions: All submissions received must include the Docket No.
FDA-2017-N-6356 for ``Investigational IVDs Used in Clinical
Investigations of Therapeutic Products.'' Received comments will be
placed in the docket and, except for those submitted as ``Confidential
Submissions,'' publicly viewable at https://www.regulations.gov or at
the Dockets Management Staff between 9 a.m. and 4 p.m., Monday through
Friday.
Confidential Submissions--To submit a comment with
confidential information that you do not wish to be made publicly
available, submit your comments only as a written/paper submission. You
should submit two copies total. One copy will include the information
you claim to be confidential with a heading or cover note that states
``THIS DOCUMENT CONTAINS CONFIDENTIAL INFORMATION.'' The Agency will
review this copy, including the claimed confidential information, in
its consideration of comments. The second copy, which will have the
claimed confidential information redacted/blacked out, will be
available for public viewing and posted on https://www.regulations.gov.
Submit both copies to the Dockets Management Staff. If you do not wish
your name and contact information to be made publicly available, you
can provide this information on the cover sheet and not in the body of
your comments and you must identify this information as
``confidential.'' Any information marked as ``confidential'' will not
be disclosed except in accordance with 21 CFR 10.20 and other
applicable disclosure law. For more information about FDA's posting of
comments to public dockets, see 80 FR 56469, September 18, 2015, or
access the information at: https://www.gpo.gov/fdsys/pkg/FR-2015-09-18/pdf/2015-23389.pdf.
Docket: For access to the docket to read background documents or
the electronic and written/paper comments received, go to https://www.regulations.gov and insert the docket number, found in brackets in
the heading of this document, into the ``Search'' box and follow the
prompts and/or go to the Dockets Management Staff, 5630 Fishers Lane,
Rm. 1061, Rockville, MD 20852.
You may submit comments on any guidance at any time (see 21 CFR
10.115(g)(5)).
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 draft guidance document entitled
``Investigational IVDs Used in Clinical Investigations of Therapeutic
Products'' 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; or the 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
assist that office in processing your request.
FOR FURTHER INFORMATION CONTACT: David Litwack, Center for Devices and
Radiological Health, Food and Drug Administration, 10903 New Hampshire
Ave., Bldg. 66, Rm. 4548, Silver Spring, MD 20993-0002, 301-796-6697 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, 240-402-7911.
SUPPLEMENTARY INFORMATION:
I. Background
This draft guidance is intended to assist sponsors of clinical
investigations of therapeutic products that also include
investigational IVDs and IRBs that review such investigations in
complying with the IDE regulation. This draft guidance is also intended
to assist FDA staff participating in the review of these
investigations.
This draft guidance describes when the IDE regulation may apply to
certain clinical investigations of therapeutic products; certain
regulatory requirements that sponsors should be aware of as they
develop and conduct such investigations; recommendations for
determining the risk of investigational IVD use in a therapeutic
product investigation; recommendations for IRBs in reviewing such
investigations; and recommendations for content to provide in an IDE
application, when required.
Additionally, FDA is seeking feedback on the policy in the draft
guidance regarding the need for an IDE for a significant risk study of
an investigational IVD device with a therapeutic product under an IND.
Specifically, FDA requests stakeholder perspectives on whether it would
be beneficial to allow submission of all IDE components to an IND
rather than require both an IDE and an IND. If such an approach would
be beneficial, please identify any specific circumstances, for example
a companion diagnostic and the associated therapeutic product, where
efficiency may be improved or burden may be decreased, or both, without
compromising patient safety.
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
investigational IVDs used in clinical investigations of therapeutic
products. It does not establish any rights for any person and is not
binding on FDA or the public. You can use an alternative approach if it
satisfies the requirements of the applicable statutes and regulations.
This guidance is not subject to Executive Order 12866.
III. Electronic Access
Persons interested in obtaining a copy of the draft 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 https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/GuidanceDocuments/default.htm. This draft
guidance is also available at https://www.regulations.gov. Persons
unable to download an electronic copy of ``Investigational IVDs Used in
Clinical Investigations of Therapeutic Products'' may send an email
request to [email protected] to receive an electronic copy of
the document. Please use the document number 1400025 to identify the
guidance you are requesting.
IV. Paperwork Reduction Act of 1995
This draft guidance refers to currently approved collections of
information. 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 809 have been approved under OMB control number 0910-0485; the
collections of information in parts 50 and 56 have been approved under
OMB control number 0910-0755; the collections of information in 21 CFR
56.115 have been approved under OMB control number 0910-0130; the
collections of information in 21 CFR 50.23 have been approved under OMB
control number 0910-0586; 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 820 have
[[Page 60024]]
been approved under OMB control number 0910-0073; the collections of
information in 21 CFR part 312 have been approved under OMB control
number 0910-0014; and the collections of information in 21 CFR part 314
have been approved under OMB control number 0910-0001. The collections
of information in the guidance document entitled ``Requests for
Feedback on Medical Device Submissions: The Pre-Submission Program and
Meetings with Food and Drug Administration Staff'' have been approved
under OMB control number 0910-0756.
Dated: December 12, 2017.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2017-27155 Filed 12-15-17; 8:45 am]
BILLING CODE 4164-01-P
