[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]
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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Draft Guidance for Industry and Food and Drug Administration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.
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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availability of a draft guidance entitled ``Investigational Device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approaches announced in this draft guidance, FDA intends to facilitate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 This draft guidance addresses the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 This draft guidance is not final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draft guidance before it begins work on the final version of the
guidance, submit either electronic or written comments on the draft
guidance by February 8, 2012.
ADDRESSES: Submit written requests for single copies of the draft
guidance document entitled ``Investigational Device Exemptions (IDE)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]
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