Document ID: FDA-2011-D-0790-0004
Agency: fda
Document Type: Notice
Title: Draft Guidance for Industry, Clinical Investigators, Institutional Review Boards, and Staff; Availability: Decisions for Investigational Device Exemption Clinical Investigations
Posted Date: 2011-12-27T05:00Z

[Federal Register Volume 76, Number 248 (Tuesday, December 27, 2011)]
[Notices]
[Page 80948]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2011-33141]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2011-D-0790]

Draft Guidance for Industry, Clinical Investigators, 
Institutional Review Boards, and Food and Drug Administration Staff; 
Food and Drug Administration Decisions for Investigational Device 
Exemption (IDE) Clinical Investigations; Extension of Comment Period

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice; extension of comment period.

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SUMMARY: The Food and Drug Administration (FDA) is extending the 
comment period for the notice that appeared in the Federal Register of 
Thursday, November, 10, 2011 (76 FR 70151). In the notice, FDA 
requested comments on the draft guidance that has been developed to 
promote the initiation of clinical investigations to evaluate the 
medical devices under FDA's Investigational Device Exemptions (IDE) 
regulations. The Agency is taking this action to allow interested 
persons additional time to submit comments.

DATES: Submit written or electronic comments and information by March 
9, 2012.

ADDRESSES: Submit electronic comments on the draft guidance to http://www.regulations.gov. Submit written comments to the Division of Dockets 
Management (HFA-305), Food and Drug Administration, 5630 Fishers Lane, 
rm. 1061, Rockville, MD 20852. Identify comments with the docket number 
found in brackets in the heading of this document.

FOR FURTHER INFORMATION CONTACT: Owen Faris, Center for Devices and 
Radiological Health, Food and Drug Administration, 10903 New Hampshire 
Ave., Bldg. 66, rm. 1108, Silver Spring, MD 20993-0002, (301) 796-6356.
    Stephen Ripley, Center for Biologics Evaluation and Research (HFM-
17), Food and Drug Administration, 1401 Rockville Pike, suite 200N, 
Rockville, MD 20852, (301) 827-6210.

SUPPLEMENTARY INFORMATION:

I. Background

    In the Federal Register of November 10, 2011 (76 FR 70151), FDA 
published a notice announcing the availability of the draft guidance 
entitled ``FDA Decisions for Investigational Device Exemption (IDE) 
Clinical Investigations'' and the opening of a public docket to receive 
comments on the development of methods to allow a clinical 
investigation to begin under certain circumstances, even when there are 
outstanding issues regarding the IDE submission. Interested persons 
were invited to submit comments by February 8, 2012. At this time, the 
Agency is extending the comment period until March 9, 2012, to continue 
to receive public comments. Comments submitted to the docket will 
assist in promoting timely clinical investigations actions that the 
Center for Devices and Radiological Health and Center for Biologics 
Evaluation and Research can consider taking for IDE submissions.

II. Comments

    Interested persons may submit to the Division of Dockets Management 
(see ADDRESSES) either electronic or written comments regarding this 
document. It is only necessary to submit one set of comments. It is no 
longer necessary to send two copies of mailed comments. Identify 
comments with the docket number found in the 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.

    Dated: December 21, 2011.
Leslie Kux,
Acting Assistant Commissioner for Policy.
[FR Doc. 2011-33141 Filed 12-23-11; 8:45 am]
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