[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]
-----------------------------------------------------------------------
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.
-----------------------------------------------------------------------
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
[[Page 49090]]
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.
[[Page 49091]]
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