[Federal Register Volume 76, Number 218 (Thursday, November 10, 2011)]
[Notices]
[Pages 70150-70151]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2011-29117]


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

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Draft Guidance for Industry and Food and Drug Administration 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; 
Availability

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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

SUMMARY: The Food and Drug Administration (FDA) is announcing 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availability of a draft guidance entitled ``Investigational Device 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.'' Through the 
approaches announced in this draft guidance, FDA intends to facilitate 
early feasibility studies of medical devices, using appropriate risk 
mitigation strategies, under the IDE requirements. Early feasibility 
studies allow for limited early clinical evaluations of devices to 
provide proof of principle and initial clinical safety data before the 
device design is finalized. This draft guidance addresses the 
information that should be provided to FDA in support of an early 
feasibility study IDE application and explains the requirements 
applicable to modifications to the device design or clinical protocol 
during the early feasibility study. This draft guidance is not final 
nor is it in effect at this time.

DATES: Although you can comment on any guidance at any time (see 21 CFR 
10.115(g)(5)), to ensure that the Agency considers your comment on this 
draft guidance before it begins work on the final version of the 
guidance, submit either electronic or written comments on the draft 
guidance by February 8, 2012.

ADDRESSES: Submit written requests for single copies of the draft 
guidance document entitled ``Investigational Device Exemptions (IDE) 
for Early Feasibility Medical Device Clinical Studies, Including 
Certain First in Human (FIH) Studies'' to the Division of Small 
Manufacturers, International, and

[[Page 70151]]

Consumer Assistance, Center for Devices and Radiological Health, Food 
and Drug Administration, 10903 New Hampshire Ave., Bldg. 66, rm. 4613, 
Silver Spring, MD 20993-0002. Send one self-addressed adhesive label to 
assist that office in processing your request, or fax your request to 
(301) 847-8149. See the SUPPLEMENTARY INFORMATION section for 
information on electronic access to the guidance.
    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.

SUPPLEMENTARY INFORMATION: 

I. Background

    This draft guidance is intended to provide assistance to FDA staff, 
clinicians, clinical innovators, and industry on the development and 
review of IDE applications (21 CFR 812.20) for early feasibility 
studies of significant risk devices. Early feasibility studies allow 
for early clinical evaluation of devices to provide proof of principle 
and initial clinical safety data in a limited number of subjects. 
During these studies, iterative device modifications are likely to be 
made based on clinical experience. Early feasibility studies may be 
appropriate early in device development when nonclinical testing 
methods are not available or adequate to provide the information needed 
to advance the developmental process, and clinical experience is thus 
necessary. As with all clinical studies, initiation of an early 
feasibility study must be justified by an appropriate risk-benefit 
analysis and adequate human subject protection measures.
    This draft guidance discusses 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. This draft guidance is not intended 
to address all required elements of an IDE application generally or to 
provide a comprehensive tutorial on best clinical practices for 
investigational medical device studies.

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 IDE for 
early feasibility studies. 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.
    Elsewhere in this issue of the Federal Register, FDA is announcing 
the solicitation of nominations from sponsors of innovative device 
technologies to participate in a pilot program for early feasibility 
study IDE applications, which implements the approaches announced in 
this draft guidance. The experience gained from the pilot program will 
be used to inform the final version this draft guidance.

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 CDRH guidance 
documents is available at http://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/GuidanceDocuments/default.htm. Guidance 
documents are also available at http://www.regulations.gov.
    You may either send an email request to [email protected] to 
receive an electronic copy of this draft guidance or send a fax request 
to (301) 847-8149 to receive a hard copy. Please use the document 
number 1782 to identify the guidance you are requesting.

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 812 have been approved under 
OMB control number 0910-0078.

V. 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 send one set of comments. It is no 
longer necessary to send two copies of mailed 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.

    Dated: November 4, 2011.
Leslie Kux,
Acting Assistant Commissioner for Policy.
[FR Doc. 2011-29117 Filed 11-9-11; 8:45 am]
BILLING CODE 4160-01-P