[Federal Register Volume 79, Number 160 (Tuesday, August 19, 2014)]
[Notices]
[Pages 49089-49091]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2014-19577]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2011-D-0790]


Food and Drug Administration Decisions for Investigational Device 
Exemption Clinical Investigations: Guidance for Sponsors, Clinical 
Investigators, Institutional Review Boards, and Food and Drug 
Administration Staff; 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 guidance entitled ``FDA Decisions for 
Investigational Device Exemption (IDE) Clinical Investigations.'' This 
guidance document was developed to promote the initiation of clinical 
investigations to evaluate medical devices under FDA's IDE regulations. 
The 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 reasons 
for those decisions.

DATES: Submit either electronic or written comments on this guidance at 
any time. General comments on Agency guidance documents are welcome at 
any time.

ADDRESSES: An electronic copy of the guidance document is available for 
download from the Internet. See the SUPPLEMENTARY INFORMATION section 
for information on electronic access to the guidance. Submit written 
requests for a single hard copy of the guidance document entitled ``FDA 
Decisions for Investigational Device Exemption Clinical 
Investigations'' to the Office of the Center Director, Guidance and 
Policy Development, Center for Devices and Radiological Health, Food 
and Drug Administration, 10903 New Hampshire Ave., Bldg. 66, Rm. 5431, 
Silver Spring, MD 20993-0002; or the Office of Communication, Outreach 
and Development, Center for Biologics Evaluation and Research, Food and 
Drug Administration, 10903 New Hampshire Ave., Bldg. 71, Rm. 3128, 
Silver Spring, MD 20993-0002. Send one self-addressed adhesive label to 
assist that office in processing your request.
    Submit electronic comments on the 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. 1522, Silver Spring, MD 20993-0002, 301-796-6210; 
or Stephen Ripley, Center for Biologics Evaluation and Research, Food 
and Drug Administration, 10903 New Hampshire Ave., Bldg. 71, Rm. 7301, 
Silver Spring, MD 20993, 240-402-7911.

SUPPLEMENTARY INFORMATION: 

I. Background

    FDA seeks to encourage medical device research and innovation to 
address important clinical needs and improve patient care. In many 
cases, device development and evaluation include clinical 
investigation. This guidance document has been developed to facilitate 
the initiation of clinical investigations to evaluate medical devices 
under FDA's IDE regulations, part 812 (21 CFR part 812).
    FDA approval of an IDE submission allows the initiation of subject 
enrollment in a significant risk clinical investigation of a medical 
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 reasons 
for those decisions.
    In an effort to promote timely initiation of subject enrollment in 
clinical investigations in a manner that protects study subjects, FDA 
has developed methods to allow a clinical investigation of a device to 
begin under certain circumstances, even when outstanding issues 
regarding the IDE submission remain. These mechanisms, including 
Approval with Conditions, Staged Approval, and communication of 
outstanding issues related to the IDE through Study Design 
Considerations and Future Considerations, are described in this 
guidance.
    FDA's decision-making process for IDEs was modified with passage of 
the

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Food and Drug Administration Safety and Innovation Act (FDASIA) (Pub. 
L. 112-144). Section 601 of FDASIA amended section 520(g) of the 
Federal Food, Drug, and Cosmetic Act (the FD&C Act) (21 U.S.C. 360j(g)) 
to specify certain situations in which FDA cannot disapprove an IDE. 
Section 520(g)(4)(C) of the FD&C Act states that, consistent with 
section 520(g)(1), FDA shall not disapprove an IDE because: (1) The 
investigation may not support a substantial equivalence or de novo 
classification determination or approval of the device; (2) the 
investigation may not meet a requirement, including a data requirement, 
relating to the approval or clearance of a device; or (3) an additional 
or different investigation may be necessary to support clearance or 
approval of the device. However, the Agency recognizes that some IDE 
sponsors may wish to ensure that a pivotal study's design may support a 
marketing application if it is successfully executed, meets its stated 
endpoints, and does not raise unforeseen safety concerns. FDA is 
interested in working interactively with sponsors to assist in 
addressing important limitations with such a study that might impair 
its ability to support a future marketing application.
    In the draft guidance, issued on June 14, 2013 (78 FR 35937), FDA 
specifically sought public comment on three questions. Based on its 
consideration of that feedback, the Agency has revised the guidance as 
discussed further in this document.

A. Inclusion of Study Design Considerations in FDA's Decision Letters

    If FDA believes that modifications to the study design unrelated to 
the safety, rights, or welfare of study subject are needed to enable a 
sponsor to rely on the study as primary clinical support for a future 
marketing approval or clearance, those modifications will be noted as 
``study design considerations'' (SDCs). Sponsors are not required to 
modify the investigational plan to address SDCs. However, if these 
considerations are not addressed, the study design may not support the 
study goals (e.g., a future marketing application). The draft guidance 
proposed that SDCs be included in a section of the IDE decision letter.
    FDA received comments from several stakeholders proposing that FDA 
provide SDCs and its assessment of the study design in a communication 
separate from the decision letter. Other stakeholders expressed support 
for inclusion of SDCs in the letter. Still others focused on ensuring 
that the decision letter clearly conveys whether FDA believes the study 
design is adequate to support its goals, even if the actual SDCs are 
conveyed separately from the letter.
    Based on the comments received, FDA believes that sponsors and 
other stakeholders may misinterpret SDCs included in the body of a 
decision letter as issues that are required to be addressed. Therefore, 
FDA intends to convey SDCs in a separate attachment included with the 
decision letter, rather than in the body of the letter. The decision 
letter itself will state whether FDA believes that the study design is 
adequate to support the study goals or whether FDA recommends study 
design considerations to enable it to do so. If FDA recommends SDCs, 
FDA's letter will note the following: ``These recommendations do not 
relate to the safety, rights or welfare of study subjects, and they do 
not need to be addressed in order for you to conduct your study.'' FDA 
will continue to engage with stakeholders on this issue and may make 
modifications to this approach in the future.

B. Inclusion of Future Considerations in FDA's Decision Letters

    Future considerations are issues and recommendations that FDA 
believes the sponsor should consider in preparing for a marketing 
application or a future clinical investigation. Future considerations 
are intended to provide helpful, non-binding advice to sponsors 
regarding important elements of the future application that the IDE may 
not specifically address. FDA sought comment on whether future 
considerations should be communicated in its IDE decision letters or 
whether they should be sent to the sponsor in a separate communication. 
FDA received comments proposing that the Agency provide future 
considerations as a separate communication and not in the decision 
letter. Based on the comments received, FDA intends to convey future 
considerations in a separate attachment included with the decision 
letter rather than in the body of the letter.

C. Utility of the Proposed Pre-Decisional IDE Process

    The draft guidance proposed a new mechanism for review and 
interaction for pivotal IDEs called the Pre-Decisional IDE. The process 
included a comprehensive FDA review of a draft IDE prior to formal IDE 
submission, followed by written feedback from FDA and an interactive 
discussion between FDA and the sponsor. The goal of the Pre-Decisional 
IDE was to facilitate the development of an improved IDE submission 
more likely to be approved as well as a study design adequate to 
support a future marketing application.
    FDA specifically sought comment on the expected utility of the Pre-
Decisional IDE process. Some commenters expressed support for the 
proposal and felt that it might shorten the time to full approval of 
pivotal IDE studies. Other commenters expressed concern that the Pre-
Decisional IDE process itself might be too time-consuming or require 
extensive FDA resources that could be better allocated elsewhere. Based 
on the comments received and FDA's consideration of the points raised, 
FDA will not pursue the Pre-Decisional IDE at the present time.

II. Significance of Guidance

    This guidance is being issued consistent with FDA's good guidance 
practices regulation (21 CFR 10.115). The guidance represents the 
Agency's current thinking on decisions for 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 guidance may do so by 
downloading an electronic copy from the Internet. A search capability 
for all Center for Devices and Radiological Health 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 http://www.fda.gov/BiologicsBloodVaccines/GuidanceComplianceRegulatoryInformation/Guidances/default.htm. Persons 
unable to download an electronic copy of ``Decisions for 
Investigational Device Exemption Clinical Investigations,'' may send an 
email request to [email protected] to receive an electronic 
copy of the document. Please use the document number 1783 to identify 
the guidance you are requesting.

IV. Paperwork Reduction Act of 1995

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

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V. Comments

    Interested persons may submit either electronic comments regarding 
this document to http://www.regulations.gov or written comments to the 
Division of Dockets Management (see ADDRESSES). It is only necessary to 
send one set of 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, and will be posted to the docket at http://www.regulations.gov.

    Dated: August 13, 2014.
Leslie Kux,
Assistant Commissioner for Policy.
[FR Doc. 2014-19577 Filed 8-18-14; 8:45 am]
BILLING CODE 4164-01-P