
[Federal Register Volume 76, Number 218 (Thursday, November 10, 2011)]
[Notices]
[Pages 70151-70152]
From the Federal Register Online via the Government Printing 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Draft Guidance for Industry, Clinical Investigators, 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availability of the draft guidance entitled ``FDA Decisions for 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draft guidance before it begins work on the final version of the 
guidance, submit either electronic or written comments on the draft 
guidance by February 8, 2012.

ADDRESSES: Submit written requests for single copies of the draft 
guidance document entitled ``FDA Decisions for Investigational Device 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 
dsmica@fda.hhs.gov 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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