[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will conform to the approaches outlined in the draft guidance entitled 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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