Pilot Program for Early Feasibility Study Investigational Device Exemption Applications; Extending the Duration of the Program, 23941 [2013-09528]

Download as PDF Federal Register / Vol. 78, No. 78 / Tuesday, April 23, 2013 / Notices animal safety studies to justify omission of specific biocompatibility tests; (5) assessment of known or potentially toxic chemical entities; and (6) contents of a biocompatibility test report. 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 Significance of Guidance This draft guidance is being issued consistent with FDA’s good guidance practices regulation (21 CFR 10.115). The draft guidance, when finalized, will represent the Agency’s current thinking on the use of International Standard ISO–10993, ‘‘Biological Evaluation of Medical Devices Part 1: Evaluation and Testing.’’ 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. 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 Electronic Access Persons interested in obtaining a copy of the draft guidance may do so by using the Internet.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 Center for Devices and Radiological Health guidance documents is available at https://www.fda.gov/MedicalDevices/ DeviceRegulationandGuidance/ GuidanceDocuments/default.htm. Guidance documents are also available at https://www.regulations.gov. To receive ‘‘Use of International Standard ISO–10993, ‘Biological Evaluation of Medical Devices Part 1: Evaluation and Testing,’ ’’ you may either send an email request to dsmica@fda.hhs.gov to 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 1811 to identify the guidance you are requesting. mstockstill on DSK4VPTVN1PROD with NOTICES 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 Paperwork Reduction Act of 1995 This draft guidance refers to previously approved collections of information found in FDA regulations.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 807, subpart E, have been approved under OMB control number 0910–0120; the collections of information in 21 CFR part 814, have been approved under OMB control number 0910–0231; the collections of information in 21 CFR part 814, subpart H, have been approved under OMB control number 0910–0332; and the collections of information in 21 CFR part 812, have been approved under OMB control number 0910–0078. VerDate Mar<15>2010 17:51 Apr 22, 2013 Jkt 229001 V. Comments Interested persons may submit either electronic comments regarding this document to https://www.regulations.gov or written comments to the Division of Dockets Management (see ADDRESSES). It is only necessary to send one set of 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, and will be posted to the docket at https:// www.regulations.gov. Dated: April 16, 2013. Leslie Kux, Assistant Commissioner for Policy. [FR Doc. 2013–09479 Filed 4–22–13; 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; Extending the Duration of the Program AGENCY: Food and Drug Administration, HHS. ACTION: 23941 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] Notice. BILLING CODE 4160–01–P 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. SUMMARY: 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 SUPPLEMENTARY INFORMATION: PO 00000 Frm 00059 Fmt 4703 Sfmt 4703 DEPARTMENT OF HEALTH AND HUMAN SERVICES Health Resources and Services Administration Advisory Committee on Infant Mortality; Notice of Meeting In accordance with section 10(a)(2) of the Federal Advisory Committee Act (Public Law 92–463), notice is hereby given of the following meeting: Name: Advisory Committee on Infant Mortality (ACIM). Dates and Times: April 24, 2013, 8:00 a.m.–5:00 p.m., April 25, 2013, 8:00 a.m.– 3:00 p.m. Place: Virtual via Webinar. Status: The meeting is open to the public. For more information on registration and webinar details, please visit the ACIM Web site: https://www.hrsa.gov/ advisorycommittees/mchbadvisory/ InfantMortality. Adobe Connect: https:// hrsa.connectsolutions.com/ infantmortality/. Teleconference Number: (888) 790–1958. Participant passcode: 461–8352. Purpose: The Committee provides advice and recommendations to the Secretary of E:\FR\FM\23APN1.SGM 23APN1

Agencies

[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

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