[Federal Register Volume 76, Number 218 (Thursday, November 10, 2011)]
[Notices]
[Pages 70151-70152]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2011-29118]
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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Draft Guidance for Industry, Clinical Investigators,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 Clinical Investigations; 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availability of the draft guidance entitled ``FDA Decisions for
Investigational Device Exemption (IDE) Clinical Investigations.'' This
guidance document has been developed to promote the initiation of
clinical investigations to evaluate medical devices under FDA's IDE
regulations. In an effort to promote timely clinical investigations in
a manner that protects study subjects, FDA has developed methods to
allow a clinical investigation to begin under certain circumstances,
even when there are outstanding issues regarding the IDE submission.
These mechanisms, including approval with conditions, staged approval
or staged approval with conditions, and communication of outstanding
issues related to the IDE through future considerations, are described
in this guidance.
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draft guidance before it begins work on the final version of the
guidance, submit either electronic or written comments on the draft
guidance by February 8, 2012.
ADDRESSES: Submit written requests for single copies of the draft
guidance document entitled ``FDA Decisions for Investigational Device
Exemption (IDE) Clinical Investigations'' to the Division of Small
Manufacturers, International and Consumer Assistance, Center for
Devices and Radiological Health, Food
[[Page 70152]]
and Drug Administration, 10903 New Hampshire Ave., Bldg. 66, rm. 4613,
Silver Spring, MD 20993-0002; or to the Office of Communication,
Outreach and Development (HFM-40), Center for Biologics Evaluation and
Research (CBER), Food and Drug Administration, 1401 Rockville Pike,
Rockville, MD 20852-1448. 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:
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; or
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.
I. Background
FDA approval of an IDE submission allows the initiation of a
clinical investigation of a significant risk device. This guidance is
intended to provide clarification regarding the regulatory implications
of the decisions that FDA may render based on review of an IDE and to
provide a general explanation of the reasoning and implications of
those decisions. FDA has traditionally referred to IDE approvals that
have conditions as ``Conditional Approvals.'' FDA believes that the
term ``Approval with Conditions'' is more appropriate because the term
conveys that the IDE has been approved and may begin without awaiting
further FDA review. An IDE may be approved with conditions if FDA has
determined, despite outstanding issues, that the information provided
is sufficient to justify human clinical evaluation of the device, and
that the proposed study design is generally acceptable. FDA may now
also include ``future considerations'' in an approval or approval with
conditions letter, which are issues and recommendations that FDA
believes the sponsor should consider in preparation for a marketing
application or a future clinical investigation. Future considerations
are intended to provide helpful advice to sponsors regarding important
elements of the future application that the IDE may not specifically
address.
In this guidance new mechanisms are introduced, termed ``stage
approval'' and ``staged approval with conditions,'' by which FDA may
grant IDE approval or approval with conditions, while certain
outstanding questions are being answered in parallel with enrollment in
the clinical investigation. Staged approval and staged approval with
conditions permit the clinical investigation to begin in a timely
manner while maintaining appropriate subject protections. Staged
approval or staged approval with conditions is most common for pivotal
studies in which many subjects will be enrolled over an extended period
of time, but may be applicable to other clinical investigations as
well.
As a result of this draft guidance, FDA, where appropriate, seeks
to offer flexibility in how outstanding issues can be addressed to
allow clinical investigations to commence without unnecessary delay,
while ensuring that human subjects are adequately protected.
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 ``FDA
Decisions for Investigational Device Exemption (IDE) Clinical
Investigations.'' 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 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 or from the
CBER Internet site at http://www.fda.gov/BiologicsBloodVaccines/GuidanceComplianceRegulatoryInformation/default.htm. To receive ``FDA
Decisions for Investigational Device Exemption (IDE) Clinical
Investigations'' you may either send an email request to
[email protected] 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 1783 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. 2011-29118 Filed 11-9-11; 8:45 am]
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