Document ID: FDA-2011-D-0787-0003
Agency: fda
Document Type: Notice
Title: Draft Guidance for Industry and Staff; Availability: Investigational Device Exemptions for Early Feasibility Medical Device Clinical Studies, Including Certain First in Human Studies
Posted Date: 2011-12-27T05:00Z

[Federal Register Volume 76, Number 248 (Tuesday, December 27, 2011)]
[Notices]
[Pages 80947-80948]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2011-33142]

-----------------------------------------------------------------------

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2011-D-0787]

Draft Guidance for Industry and Food and Drug Administration 
Staff; Investigational Device Exemptions for Early Feasibility Medical 
Device Clinical Studies, Including Certain First in Human Studies; 
Extension of Comment Period

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice; extension of comment period.

-----------------------------------------------------------------------

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 70150). In the notice, FDA 
requested comments on the draft guidance that addresses the approaches 
FDA intends to facilitate early feasibility studies of medical devices, 
using appropriate risk mitigation strategies, under the investigational 
device exemption (IDE) requirements. The Agency is taking this

[[Page 80948]]

action to allow interested persons additional time to submit comments.

DATES: Submit either electronic or written 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ADDRESSES: Submit electronic comments on the draft guidance to http://www.regulations.gov.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: Dorothy Abel, Center for Devices and 
Radiological Health, Food and Drug Administration, 10903 New Hampshire 
Ave., Bldg. 66, rm. 1204, Silver Spring, MD 20993-0002, (301) 796-6366.

I. Background

    In the Federal Register of November 10, 2011 (76 FR 70150), FDA 
published a notice announcing the availability of the draft guidance 
entitled ``Investigational Device Exemptions (IDE) for Early 
Feasibility Medical Device Clinical Studies, Including Certain First in 
Human (FIH) Studies'' and the opening of a public docket to receive 
comments on the key principles unique to the justification for, and 
design of, early feasibility studies, as well as outlines the general 
principles for preparing and reviewing early feasibility study IDE 
applications that are discussed in the guidance. 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 
enhance the development and review of IDE applications for early 
feasibility studies of significant risk for the industry and the Center 
for Devices and Radiological Health.

II. Request for 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. 2011-33142 Filed 12-23-11; 8:45 am]
BILLING CODE 4160-01-P