Document ID: FDA-2011-N-0788-0002
Agency: fda
Document Type: Notice
Title: Pilot Program for Early Feasibility Study Investigational Device Exemption Applications: Termination of Acceptance of Nominations and Extending Duration of Program
Posted Date: 2012-03-06T05:00Z

[Federal Register Volume 77, Number 44 (Tuesday, March 6, 2012)]
[Notices]
[Pages 13343-13344]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2012-5311]

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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; Termination of Acceptance of Nominations and 
Extending the Duration of the Program

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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SUMMARY: The Food and Drug Administration (FDA) is announcing the 
termination of the acceptance of nominations for the Early Feasibility 
Study Investigational Device Exemption (IDE) Applications pilot 
program. This program allowed the submission of nominations from 
sponsors of innovative device technologies to participate in a pilot 
program for early feasibility study IDE applications. FDA is also 
announcing that the duration of the pilot program is extended to May 8, 
2013, for sponsors that have already been accepted for the program.

DATES: This notice is effective March 6, 2012.

FOR FURTHER INFORMATION CONTACT: Sheila Brown, Center for Devices and 
Radiological Health, Food and Drug Administration, 10903 New Hampshire 
Ave., Bldg. 66, Rm. 1676, Silver Spring, MD 20993-0002, 301-796-5640.

SUPPLEMENTARY INFORMATION: In the Federal Register of November 10, 2011 
(76 FR 70150), FDA announced the availability of a draft guidance 
entitled ``Investigational Device Exemptions (IDE) for Early 
Feasibility Medical Device Clinical Studies, Including Certain First in 
Human (FIH) Studies.'' This guidance document is intended to facilitate 
early feasibility studies of medical devices, using appropriate risk 
mitigation strategies, under the IDE requirements. Simultaneous with 
the publication of the draft guidance, FDA also announced an Early 
Feasibility Study IDE Pilot Program (76 FR 70152, November 10, 2011) 
intended to collect

[[Page 13344]]

information and experience on the application of the draft guidance in 
order to inform the final guidance document.
    FDA began accepting nominations for the pilot program on December 
12, 2011. In the Federal Register notice announcing the pilot program, 
FDA stated its intention to limit the pilot program to nine candidates. 
After review of the nominations received in response to the pilot 
program notice, FDA accepted nine appropriate candidates for the pilot 
program.
    In the pilot program notice, FDA stated its intention to accept 
nominations to participate in the pilot program until May 8, 2012. 
Because FDA has already accepted nine sponsors to participate in the 
program, FDA will no longer accept nominations to participate in the 
program and will conduct the pilot program for the nine sponsors that 
have already been accepted.
    In the pilot program notice, FDA also stated that the pilot program 
will terminate on May 8, 2012. Instead, the pilot program will be 
extended for the nine accepted sponsors until May 8, 2013.

    Dated: February 28, 2012.
Leslie Kux,
Acting Assistant Commissioner for Policy.
[FR Doc. 2012-5311 Filed 3-5-12; 8:45 am]
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