[Federal Register Volume 76, Number 218 (Thursday, November 10, 2011)]
[Notices]
[Pages 70152-70154]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2011-29116]
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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.
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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will conform to the approaches outlined in the draft guidance entitled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
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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.
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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]
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