Pilot Program for Early Feasibility Study Investigational Device Exemption Applications, 70152-70154 [2011-29116]
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70152
Federal Register / Vol. 76, No. 218 / Thursday, November 10, 2011 / Notices
jlentini on DSK4TPTVN1PROD with NOTICES
and Drug Administration, 10903 New
Hampshire Ave., Bldg. 66, rm. 4613,
Silver Spring, MD 20993–0002; or to the
Office of Communication, Outreach and
Development (HFM–40), Center for
Biologics Evaluation and Research
(CBER), Food and Drug Administration,
1401 Rockville Pike, Rockville, MD
20852–1448. 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 on the
draft guidance to https://
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:
Owen Faris, Center for Devices and
Radiological Health, Food and Drug
Administration, 10903 New
Hampshire Ave., Bldg. 66, rm. 1108,
Silver Spring, MD 20993–0002, (301)
796–6356; 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.
I. Background
FDA approval of an IDE submission
allows the initiation of a clinical
investigation of a significant risk device.
This guidance is intended to provide
clarification regarding the regulatory
implications of the decisions that FDA
may render based on review of an IDE
and to provide a general explanation of
the reasoning and implications of those
decisions. FDA has traditionally
referred to IDE approvals that have
conditions as ‘‘Conditional Approvals.’’
FDA believes that the term ‘‘Approval
with Conditions’’ is more appropriate
because the term conveys that the IDE
has been approved and may begin
without awaiting further FDA review.
An IDE may be approved with
conditions if FDA has determined,
despite outstanding issues, that the
information provided is sufficient to
justify human clinical evaluation of the
device, and that the proposed study
design is generally acceptable. FDA may
now also include ‘‘future
considerations’’ in an approval or
approval with conditions letter, which
are issues and recommendations that
FDA believes the sponsor should
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16:38 Nov 09, 2011
Jkt 226001
consider in preparation for a marketing
application or a future clinical
investigation. Future considerations are
intended to provide helpful advice to
sponsors regarding important elements
of the future application that the IDE
may not specifically address.
In this guidance new mechanisms are
introduced, termed ‘‘stage approval’’
and ‘‘staged approval with conditions,’’
by which FDA may grant IDE approval
or approval with conditions, while
certain outstanding questions are being
answered in parallel with enrollment in
the clinical investigation. Staged
approval and staged approval with
conditions permit the clinical
investigation to begin in a timely
manner while maintaining appropriate
subject protections. Staged approval or
staged approval with conditions is most
common for pivotal studies in which
many subjects will be enrolled over an
extended period of time, but may be
applicable to other clinical
investigations as well.
As a result of this draft guidance,
FDA, where appropriate, seeks to offer
flexibility in how outstanding issues can
be addressed to allow clinical
investigations to commence without
unnecessary delay, while ensuring that
human subjects are adequately
protected.
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 1783 to
identify the guidance you are
requesting.
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 ‘‘FDA Decisions for Investigational
Device Exemption (IDE) Clinical
Investigations.’’ 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 statute
and regulations.
Dated: November 4, 2011.
Leslie Kux,
Acting Assistant Commissioner for Policy.
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 https://www.fda.gov/MedicalDevices/
DeviceRegulationandGuidance/
GuidanceDocuments/default.htm.
Guidance documents are also available
at https://www.regulations.gov or from
the CBER Internet site at https://
www.fda.gov/BiologicsBloodVaccines/
GuidanceComplianceRegulatory
Information/default.htm. To receive
‘‘FDA Decisions for Investigational
Device Exemption (IDE) Clinical
Investigations’’ you may either send an
email request to dsmica@fda.hhs.gov to
PO 00000
Frm 00046
Fmt 4703
Sfmt 4703
IV. Paperwork Reduction Act of 1995
This draft 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 812 have
been approved under OMB control
number 0910–0078.
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.
[FR Doc. 2011–29118 Filed 11–9–11; 8:45 am]
BILLING CODE 4160–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2011–N–0788]
Pilot Program for Early Feasibility
Study Investigational Device
Exemption Applications
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Notice.
The Food and Drug
Administration (FDA) is soliciting
nominations from sponsors of
innovative device technologies to
participate in a pilot program for early
feasibility study investigational device
exemption (IDE) applications. The pilot
program will conform to the approaches
outlined in the draft guidance entitled
‘‘Investigational Device Exemptions
(IDE) for Early Feasibility Medical
Device Clinical Studies, Including
Certain First in Human (FIH) Studies.’’
Under the pilot program, FDA’s review
SUMMARY:
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Federal Register / Vol. 76, No. 218 / Thursday, November 10, 2011 / Notices
jlentini on DSK4TPTVN1PROD with NOTICES
of IDE applications for an early
feasibility study, including a first in
human study, is expected to be based on
less nonclinical data than would be
expected for a traditional feasibility or
a pivotal study. The pilot will also
involve new approaches to IDE review
to facilitate timely device and clinical
protocol modifications during an early
feasibility study.
DATES: FDA will begin accepting
nominations for participation in the
voluntary pilot program on December
12, 2011.
FOR FURTHER INFORMATION CONTACT:
Sheila Brown, Center for Devices and
Radiological Health, Food and Drug
Administration, 10903 New Hampshire
Ave. Bldg. 66, rm. 1676, Sliver Spring,
MD 20993–0002, (301) 796–5640.
SUPPLEMENTARY INFORMATION:
I. Background
Early feasibility studies allow for
early clinical evaluation of significant
risk devices to provide proof of
principle and initial clinical safety data.
During these studies, iterative device
modifications are likely to be made
based on clinical experience. Early
feasibility studies may be appropriate
early in the device development process
in a limited number of subjects when
nonclinical testing methods are not
available or adequate to provide the
information needed to advance the
development process, making clinical
experience necessary. As with all
clinical studies, the initiation of an early
feasibility study must be justified by an
appropriate risk-benefit analysis and
adequate human subject protection
measures. Because these studies are
performed early in the device
development process before the device
design is finalized and are only
appropriate where additional
nonclinical testing is not available or
adequate to provide the information
needed to advance device development,
the information included in the IDE
application may vary from the
information typically included in IDE
applications for traditional feasibility or
pivotal studies. To address the unique
challenge of early feasibility studies,
elsewhere in this issue of the Federal
Register, FDA is announcing the
availability of the early feasibility study
draft guidance.
The anticipated benefits of this pilot
program include facilitating
development of innovative products in
the United States and evaluating the
new approaches for modifications made
during early feasibility studies, which
are outlined in the early feasibility
study draft guidance. The information
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16:38 Nov 09, 2011
Jkt 226001
learned and experiences gained from the
pilot program will help inform the final
guidance document.
II. Early Feasibility Study IDE Pilot
Program
FDA has developed a pilot program
that presents a streamlined process to
interested sponsors/requesters. This
notice outlines: (1) The guiding
principles underlying the pilot program,
(2) appropriate candidates for the pilot
program, and (3) the procedures FDA
intends to follow in the pilot program
for early feasibility IDEs.
70153
C. Procedures
FDA has developed the following
procedures to ensure adequate
information to assess a candidate’s
suitability for the pilot program is
provided to FDA without creating a
burdensome new application process:
1. Nomination
The following basic principles
underline the early feasibility study IDE
pilot program described in this notice.
FDA intends that these principles create
a common understanding between the
sponsor and FDA about the goals and
parameters of the early feasibility study
IDE application pilot program:
1. FDA will not publicly disclose
participation of a sponsor in the early
feasibility IDE pilot program, unless the
sponsor consents or has already made
this information public, or disclosure is
required by law.
2. Participating in this pilot program
does not guarantee approval of an IDE
application, nor is a sponsor precluded
from withdrawing from the pilot
program and pursuing traditional IDE
review.
3. Due to FDA resource issues, FDA
intends to limit the pilot program to
nine candidates.
The sponsor/requester of an
innovative therapeutic or diagnostic
device may nominate their study for
participation in the pilot program by
submitting a nomination to the CDRH
Document Mail Center (Food and Drug
Administration, Center for Devices and
Radiological Health, Document Mail
Center, Bldg. 66, rm. G609, 10903 New
Hampshire Ave., Silver Spring, MD
20993–0002), with a duplicate copy sent
to the Investigational Device Exemption
Section (see FOR FURTHER INFORMATION
CONTACT). FDA intends to acknowledge
receipt of nominations via email. The
following information will assist FDA in
processing and responding to
nominations:
• Name of the sponsor/requester and
relevant contact information,
• Name of the product,
• Succinct description of the
technology and disease or condition the
device is intended to diagnose or treat,
and
• A brief statement explaining why
the device is an appropriate candidate
for the pilot program as described in
this document in section B. Appropriate
Candidates.
B. Appropriate Candidates
2. FDA Consideration
Appropriate candidates for the pilot
program are medical devices for which:
1. The sponsor has not already
submitted an IDE application.
2. An application for premarket
review or approval would require the
submission of clinical data.
3. Limited clinical study of the device
(e.g., generally fewer than 10 initial
subjects) is necessary because additional
nonclinical testing is unlikely to
provide the insights necessary to further
the development of the device, or
appropriate nonclinical tests are
unavailable.
FDA encourages any interested
sponsors who believe their device and/
or study are appropriate candidates to
contact FDA through the Center for
Devices and Radiological Health
(CDRH), Investigational Device
Exemption Section at (301) 796–5640,
before initiating the procedures
referenced in this document in section
C. Procedures.
FDA intends to consider each
nomination within 30 days of receiving
the complete information described in
this document in section C. Procedures.
FDA may contact the sponsor/requester
to request supplemental information
during the 30-day review period.
A. Guiding Principles
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3. Sponsor/Requester Notification
FDA intends to notify the sponsor/
requester whether or not the product is
an appropriate candidate for the early
feasibility study IDE pilot program
within 30 days from receiving the
complete information described in this
document in section C. Procedures.
4. Acceptance Meeting
If the nominee is deemed an
appropriate candidate, FDA intends to
meet with the product sponsor/
requester, either in person or by
telephone, within 30 days of notifying
the sponsor/requester that its nominee
was accepted.
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70154
Federal Register / Vol. 76, No. 218 / Thursday, November 10, 2011 / Notices
jlentini on DSK4TPTVN1PROD with NOTICES
5. FDA Review
Under the pilot program, early
feasibility study IDE applications will
be reviewed according to the
approaches outlined in the early
feasibility study draft guidance. The
essential elements announced in the
early feasibility study draft guidance
are:
• FDA may approve an IDE
application for an early feasibility study,
including certain first in human studies,
based on less nonclinical data than
would be expected for a traditional
feasibility or a pivotal study. This is
because early feasibility studies are only
appropriate where additional
nonclinical testing is not available or
adequate to provide the information
needed to advance the developmental
process. Identification of the data
necessary to support an early feasibility
study should be based on a thorough
device evaluation strategy that describes
the device and procedure-related
attributes and addresses the potential
failure modes. Appropriate human
subject protection measures and risk
mitigation strategies must also be
identified. This policy is intended to
facilitate initiation of clinical studies in
the United States earlier in the device
development process than has
historically occurred, when appropriate.
• New approaches that facilitate
timely device and clinical protocol
modifications during an early feasibility
study while still requiring compliance
with the IDE regulations in 21 CFR part
812.
FDA has provided additional
information regarding its expectations
for early feasibility study IDE
applications in the early feasibility
study draft guidance.
D. Duration of the Pilot
FDA intends to accept requests for
participation in the pilot program for
180 days from the date of publication of
this notice. FDA may decide to
terminate the pilot program before the
close of the 180-day period or extend
the pilot program beyond the 180-day
period. The decision to terminate or
extend the pilot will be announced in
the Federal Register. FDA may also
decide to modify the pilot program
while it is in effect. Any modifications
will also be announced in the Federal
Register. FDA intends to terminate the
pilot program when the early feasibility
study draft guidance is finalized.
E. Evaluation
FDA intends to use the experience
gained from the pilot program to inform
the final version of the early feasibility
study draft guidance.
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16:38 Nov 09, 2011
Jkt 226001
Dated: November 4, 2011.
Leslie Kux,
Acting Assistant Commissioner for Policy.
[FR Doc. 2011–29116 Filed 11–9–11; 8:45 am]
BILLING CODE 4160–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
National Institutes of Health
National Heart, Lung, and Blood
Institute; Notice of Closed Meetings
Pursuant to section 10(d) of the
Federal Advisory Committee Act, as
amended (5 U.S.C. App.), notice is
hereby given of the following meetings.
The meetings will be closed to the
public in accordance with the
provisions set forth in sections
552b(c)(4) and 552b(c)(6), Title 5 U.S.C.,
as amended. The grant applications and
the discussions could disclose
confidential trade secrets or commercial
property such as patentable material,
and personal information concerning
individuals associated with the grant
applications, the disclosure of which
would constitute a clearly unwarranted
invasion of personal privacy.
Name of Committee: National Heart, Lung,
and Blood Institute Special Emphasis Panel,
Life after Linkage: The Future of Family
Studies.
Date: December 1–2, 2011.
Time: 8:30 a.m. to 5:30 p.m.
Agenda: To review and evaluate grant
applications.
Place: Hilton Garden Inn, 7301 Waverly
Street, Bethesda, MD 20814.
Contact Person: YingYing Li-Smerin, MD,
Ph.D., Scientific Review Officer, Office of
Scientific Review/DERA, National Heart,
Lung, and Blood Institute, 6701 Rockledge
Drive, Room 7184, Bethesda, MD 20892–
7924. (301) 435–0277.
lismerin@nhlbi.nih.gov.
Name of Committee: National Heart, Lung,
and Blood Institute Special Emphasis Panel,
COPD Case Finding Methodology.
Date: December 1, 2011.
Time: 9 a.m. to 2 p.m.
Agenda: To review and evaluate grant
applications.
Place: Marriott Wardman Park Washington
DC Hotel, 2660 Woodley Road NW.,
Washington, DC 20008.
Contact Person: Stephanie J Webb, Ph.D.,
Scientific Review Officer, Review Branch/
DERA, National Heart, Lung, and Blood
Institute, 6701 Rockledge Drive, Room 7196,
Bethesda, MD 20892. (301) 435–0291.
stephanie.webb@nih.gov.
Name of Committee: National Heart, Lung,
and Blood Institute Special Emphasis Panel,
PPG Review: Endothelium and
cardiovascular function.
Date: December 2, 2011.
Time: 8:30 a.m. to 4:30 p.m.
Agenda: To review and evaluate grant
applications.
PO 00000
Frm 00048
Fmt 4703
Sfmt 4703
Place: Hyatt Regency Crystal City, 2799
Jefferson Davis Highway, Arlington, VA
22202.
Contact Person: Tony L Creazzo, Ph.D.,
Scientific Review Officer.
(Catalogue of Federal Domestic Assistance
Program Nos. 93.233, National Center for
Sleep Disorders Research; 93.837, Heart and
Vascular Diseases Research; 93.838, Lung
Diseases Research; 93.839, Blood Diseases
and Resources Research, National Institutes
of Health, HHS)
Dated: November 4, 2011.
Jennifer S. Spaeth,
Director, Office of Federal Advisory
Committee Policy.
[FR Doc. 2011–29142 Filed 11–9–11; 8:45 am]
BILLING CODE 4140–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
National Institutes of Health
National Cancer Institute; Notice of
Closed Meeting
Pursuant to section 10(d) of the
Federal Advisory Committee Act, as
amended (5 U.S.C. App.), notice is
hereby given of the following meeting.
The meeting will be closed to the
public in accordance with the
provisions set forth in sections
552b(c)(4) and 552b(c)(6), Title 5 U.S.C.,
as amended. The grant applications and
the discussions could disclose
confidential trade secrets or commercial
property such as patentable material,
and personal information concerning
individuals associated with the grant
applications, the disclosure of which
would constitute a clearly unwarranted
invasion of personal privacy.
Name of Committee: National Cancer
Institute Special Emphasis Panel, Small
Grants Program for Cancer Epidemiology.
Date: November 17–18, 2011.
Time: 8:30 a.m. to 5 p.m.
Agenda: To review and evaluate grant
applications.
Place: Bethesda North Marriott Hotel &
Conference Center, 5701 Marinelli Road,
Bethesda, MD 20852.
Contact Person: Jeffrey E. DeClue, Ph.D.,
Scientific Review Officer, Special Review
and Logistics Branch, Division of Extramural
Activities, National Cancer Institute, NIH,
6116 Executive Boulevard, Room 8059,
Bethesda, MD 20892–8329, (301) 496–7904,
decluej@mail.nih.gov.
This notice is being published less than 15
days prior to the meeting due to scheduling
conflicts.
Information is also available on the
Institute’s/Center’s home page: https://
deainfo.nci.nih.gov/advisory/sep/sep.htm,
where an agenda and any additional
information for the meeting will be posted
when available.
(Catalogue of Federal Domestic Assistance
Program Nos. 93.392, Cancer Construction;
E:\FR\FM\10NON1.SGM
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]]>Agencies
[Federal Register Volume 76, Number 218 (Thursday, November 10, 2011)]
[Notices]
[Pages 70152-70154]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2011-29116]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2011-N-0788]
Pilot Program for Early Feasibility Study Investigational Device
Exemption Applications
AGENCY: Food and Drug Administration, HHS.
ACTION: Notice.
-----------------------------------------------------------------------
SUMMARY: The Food and Drug Administration (FDA) is soliciting
nominations from sponsors of innovative device technologies to
participate in a pilot program for early feasibility study
investigational device exemption (IDE) applications. The pilot program
will conform to the approaches outlined in the draft guidance entitled
``Investigational Device Exemptions (IDE) for Early Feasibility Medical
Device Clinical Studies, Including Certain First in Human (FIH)
Studies.'' Under the pilot program, FDA's review
[[Page 70153]]
of IDE applications for an early feasibility study, including a first
in human study, is expected to be based on less nonclinical data than
would be expected for a traditional feasibility or a pivotal study. The
pilot will also involve new approaches to IDE review to facilitate
timely device and clinical protocol modifications during an early
feasibility study.
DATES: FDA will begin accepting nominations for participation in the
voluntary pilot program on December 12, 2011.
FOR FURTHER INFORMATION CONTACT: Sheila Brown, Center for Devices and
Radiological Health, Food and Drug Administration, 10903 New Hampshire
Ave. Bldg. 66, rm. 1676, Sliver Spring, MD 20993-0002, (301) 796-5640.
SUPPLEMENTARY INFORMATION:
I. Background
Early feasibility studies allow for early clinical evaluation of
significant risk devices to provide proof of principle and initial
clinical safety data. During these studies, iterative device
modifications are likely to be made based on clinical experience. Early
feasibility studies may be appropriate early in the device development
process in a limited number of subjects when nonclinical testing
methods are not available or adequate to provide the information needed
to advance the development process, making clinical experience
necessary. As with all clinical studies, the initiation of an early
feasibility study must be justified by an appropriate risk-benefit
analysis and adequate human subject protection measures. Because these
studies are performed early in the device development process before
the device design is finalized and are only appropriate where
additional nonclinical testing is not available or adequate to provide
the information needed to advance device development, the information
included in the IDE application may vary from the information typically
included in IDE applications for traditional feasibility or pivotal
studies. To address the unique challenge of early feasibility studies,
elsewhere in this issue of the Federal Register, FDA is announcing the
availability of the early feasibility study draft guidance.
The anticipated benefits of this pilot program include facilitating
development of innovative products in the United States and evaluating
the new approaches for modifications made during early feasibility
studies, which are outlined in the early feasibility study draft
guidance. The information learned and experiences gained from the pilot
program will help inform the final guidance document.
II. Early Feasibility Study IDE Pilot Program
FDA has developed a pilot program that presents a streamlined
process to interested sponsors/requesters. This notice outlines: (1)
The guiding principles underlying the pilot program, (2) appropriate
candidates for the pilot program, and (3) the procedures FDA intends to
follow in the pilot program for early feasibility IDEs.
A. Guiding Principles
The following basic principles underline the early feasibility
study IDE pilot program described in this notice. FDA intends that
these principles create a common understanding between the sponsor and
FDA about the goals and parameters of the early feasibility study IDE
application pilot program:
1. FDA will not publicly disclose participation of a sponsor in the
early feasibility IDE pilot program, unless the sponsor consents or has
already made this information public, or disclosure is required by law.
2. Participating in this pilot program does not guarantee approval
of an IDE application, nor is a sponsor precluded from withdrawing from
the pilot program and pursuing traditional IDE review.
3. Due to FDA resource issues, FDA intends to limit the pilot
program to nine candidates.
B. Appropriate Candidates
Appropriate candidates for the pilot program are medical devices
for which:
1. The sponsor has not already submitted an IDE application.
2. An application for premarket review or approval would require
the submission of clinical data.
3. Limited clinical study of the device (e.g., generally fewer than
10 initial subjects) is necessary because additional nonclinical
testing is unlikely to provide the insights necessary to further the
development of the device, or appropriate nonclinical tests are
unavailable.
FDA encourages any interested sponsors who believe their device
and/or study are appropriate candidates to contact FDA through the
Center for Devices and Radiological Health (CDRH), Investigational
Device Exemption Section at (301) 796-5640, before initiating the
procedures referenced in this document in section C. Procedures.
C. Procedures
FDA has developed the following procedures to ensure adequate
information to assess a candidate's suitability for the pilot program
is provided to FDA without creating a burdensome new application
process:
1. Nomination
The sponsor/requester of an innovative therapeutic or diagnostic
device may nominate their study for participation in the pilot program
by submitting a nomination to the CDRH Document Mail Center (Food and
Drug Administration, Center for Devices and Radiological Health,
Document Mail Center, Bldg. 66, rm. G609, 10903 New Hampshire Ave.,
Silver Spring, MD 20993-0002), with a duplicate copy sent to the
Investigational Device Exemption Section (see FOR FURTHER INFORMATION
CONTACT). FDA intends to acknowledge receipt of nominations via email.
The following information will assist FDA in processing and responding
to nominations:
Name of the sponsor/requester and relevant contact
information,
Name of the product,
Succinct description of the technology and disease or
condition the device is intended to diagnose or treat, and
A brief statement explaining why the device is an
appropriate candidate for the pilot program as described in this
document in section B. Appropriate Candidates.
2. FDA Consideration
FDA intends to consider each nomination within 30 days of receiving
the complete information described in this document in section C.
Procedures. FDA may contact the sponsor/requester to request
supplemental information during the 30-day review period.
3. Sponsor/Requester Notification
FDA intends to notify the sponsor/requester whether or not the
product is an appropriate candidate for the early feasibility study IDE
pilot program within 30 days from receiving the complete information
described in this document in section C. Procedures.
4. Acceptance Meeting
If the nominee is deemed an appropriate candidate, FDA intends to
meet with the product sponsor/requester, either in person or by
telephone, within 30 days of notifying the sponsor/requester that its
nominee was accepted.
[[Page 70154]]
5. FDA Review
Under the pilot program, early feasibility study IDE applications
will be reviewed according to the approaches outlined in the early
feasibility study draft guidance. The essential elements announced in
the early feasibility study draft guidance are:
FDA may approve an IDE application for an early
feasibility study, including certain first in human studies, based on
less nonclinical data than would be expected for a traditional
feasibility or a pivotal study. This is because early feasibility
studies are only appropriate where additional nonclinical testing is
not available or adequate to provide the information needed to advance
the developmental process. Identification of the data necessary to
support an early feasibility study should be based on a thorough device
evaluation strategy that describes the device and procedure-related
attributes and addresses the potential failure modes. Appropriate human
subject protection measures and risk mitigation strategies must also be
identified. This policy is intended to facilitate initiation of
clinical studies in the United States earlier in the device development
process than has historically occurred, when appropriate.
New approaches that facilitate timely device and clinical
protocol modifications during an early feasibility study while still
requiring compliance with the IDE regulations in 21 CFR part 812.
FDA has provided additional information regarding its expectations
for early feasibility study IDE applications in the early feasibility
study draft guidance.
D. Duration of the Pilot
FDA intends to accept requests for participation in the pilot
program for 180 days from the date of publication of this notice. FDA
may decide to terminate the pilot program before the close of the 180-
day period or extend the pilot program beyond the 180-day period. The
decision to terminate or extend the pilot will be announced in the
Federal Register. FDA may also decide to modify the pilot program while
it is in effect. Any modifications will also be announced in the
Federal Register. FDA intends to terminate the pilot program when the
early feasibility study draft guidance is finalized.
E. Evaluation
FDA intends to use the experience gained from the pilot program to
inform the final version of the early feasibility study draft guidance.
Dated: November 4, 2011.
Leslie Kux,
Acting Assistant Commissioner for Policy.
[FR Doc. 2011-29116 Filed 11-9-11; 8:45 am]
BILLING CODE 4160-01-P
