Document ID: FDA-2011-N-0788-0003
Agency: fda
Document Type: Notice
Title: Pilot Program for Early Feasibility Study Investigational Device Exemption Applications; Extending the Duration of the Program
Posted Date: 2013-04-23T04:00Z

[Federal Register Volume 78, Number 78 (Tuesday, April 23, 2013)]
[Notices]
[Page 23941]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2013-09528]

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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; 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 
extension of the Early Feasibility Study Investigational Device 
Exemption (IDE) Applications pilot program to May 8, 2014, for sponsors 
who have already been accepted for the program.

DATES: This notice is effective April 23, 2013.

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, 
sheila.brown@fda.hhs.gov.

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(76 FR 70150), FDA announced the availability of a draft guidance 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. Concurrent 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publication of the draft guidance, FDA also announced an Early 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 information and experience on the application of 
the draft guidance in order to inform the final guidance document.
    In the pilot program notice, FDA stated its intention to accept 
nominations to participate in the pilot program until May 8, 2012, and 
stated that the pilot program would terminate on May 8, 2012. In the 
Federal Register notice announcing the pilot program, FDA also stated 
its intention to limit the pilot program to nine candidates.
    FDA began accepting nominations for the pilot program on December 
12, 2011. After reviewing the nominations received in response to the 
pilot program notice, FDA accepted nine appropriate candidates for the 
pilot program. In the Federal Register of March 6, 2012 (77 FR 13343), 
FDA terminated the acceptance of applications into the program and 
extended the pilot program for the nine accepted sponsors until May 8, 
2013. The pilot program will be further extended for the nine accepted 
sponsors until May 8, 2014.

    Dated: April 18, 2013.
Leslie Kux,
Assistant Commissioner for Policy.
[FR Doc. 2013-09528 Filed 4-22-13; 8:45 am]
BILLING CODE 4160-01-P