[Federal Register Volume 78, Number 190 (Tuesday, October 1, 2013)]
[Notices]
[Pages 60291-60292]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2013-23795]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2011-D-0787]
Investigational Device Exemptions for Early Feasibility Medical
Device Clinical Studies, Including Certain First in Human Studies;
Guidance for Industry 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 ``Investigational Device
Exemptions (IDEs) for Early Feasibility Medical Device Clinical
Studies, Including Certain First in Human (FIH) Studies.'' Through the
approaches announced in this guidance, FDA intends to facilitate early
feasibility studies of medical devices, using appropriate risk
mitigation strategies, under the IDE regulations. Early feasibility
studies allow for limited early clinical evaluations of devices to
provide proof of principle and initial clinical safety data, often
before the device design is finalized. This 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 study
protocol during the early feasibility study.
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: Submit written requests for single copies of the guidance
document entitled ``Investigational Device Exemptions (IDEs) for Early
Feasibility Medical Device Clinical Studies, Including Certain First in
Human (FIH) Studies'' to the Division of Small Manufacturers,
International, and Consumer Assistance, Center for Devices and
Radiological Health (CDRH), Food and Drug Administration, 10903 New
Hampshire Ave., Bldg. 66, Rm. 4613, Silver Spring, MD 20993-0002 or
Office of Communication, Outreach and Development (HFM-40), Center for
Biologics Evaluation and Research (CBER), Food and Drug Administration,
1401 Rockville Pike, Suite 200N, 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 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;
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.
SUPPLEMENTARY INFORMATION:
I. Background
This guidance is intended to provide assistance to FDA staff,
clinicians, medical device 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 clinical experience is
necessary because nonclinical testing methods are not available or
adequate to provide the information needed to advance the developmental
process. As with all clinical studies, initiation of an early
feasibility study must be justified by an appropriate benefit/risk
analysis and adequate human subject protection measures.
This guidance discusses the key principles unique to the
justification for, and design of, early feasibility studies, and
outlines the general principles for preparing and reviewing early
feasibility study IDE applications. This guidance is not intended to
address all required elements of an IDE application or to provide a
comprehensive tutorial on best clinical practices for investigational
medical device studies.
Concurrent with the publication of this guidance in draft, November
10, 2011 (76 FR 70150), FDA initiated a pilot program for early
feasibility study IDE applications (November 10, 2011, 76 FR 70152) to
solicit nominations from sponsors of innovative device technologies. In
addition to making clarifications within the final guidance in response
to comments from the public on the draft guidance, FDA has incorporated
changes based on information learned and experiences gained from the
pilot program.
II. Significance of Guidance
This guidance is being issued consistent with FDA's good guidance
practices regulation (21 CFR 10.115). This guidance represents the
Agency's current thinking on IDEs for Early Feasibility Medical Device
Clinical 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.
III. Electronic Access
Persons interested in obtaining a copy of the 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 CBER
at http://www.fda.gov/BiologicsBloodVaccines/GuidanceComplianceRegulatoryInformation/default.htm. To receive
``Investigational Device Exemptions (IDEs) for Early Feasibility
Medical Device Clinical Studies, Including Certain First in Human (FIH)
Studies,'' 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
1782 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 21 CFR part 812 have been approved under
OMB control number 0910-0078;
[[Page 60292]]
and the collections of information in 21 CFR 56.115 have been approved
under OMB control number 0910-0130.
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: September 25, 2013.
Leslie Kux,
Assistant Commissioner for Policy.
[FR Doc. 2013-23795 Filed 9-30-13; 8:45 am]
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