
[Federal Register Volume 78, Number 216 (Thursday, November 7, 2013)]
[Notices]
[Pages 66941-66942]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2013-26690]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2011-D-0567]


Design Considerations for Pivotal Clinical Investigations for 
Medical Devices; Guidance for Industry, 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 ``Design Considerations for 
Pivotal Clinical Investigations for Medical Devices.'' This document is 
intended to provide guidance to those involved in designing clinical 
studies intended to support premarket submissions for medical devices 
and for FDA staff who review those submissions. This guidance document 
describes different study design principles relevant to the development 
of medical device clinical studies that can be used to fulfill 
premarket clinical data requirements.

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 ``Design Considerations for Pivotal Clinical 
Investigations for Medical Devices'' 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 the 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 CDRH at 301-847-8149. 
See the SUPPLEMENTARY INFORMATION section for information on electronic 
access to the guidance.

[[Page 66942]]

    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:
    For devices regulated by CDRH: Gregory Campbell, Center for Devices 
and Radiological Health, Food and Drug Administration, 10903 New 
Hampshire Ave., Bldg. 66, rm. 2110, Silver Spring, MD 20993-0002, 301-
796-5750.
    For devices regulated by CBER: Stephen Ripley, Center for Biologics 
Evaluation and Research (HFM-17), Food and Drug Administration, 1401 
Rockville Pike, suite 200N, Rockville, MD 20852-1448, 301-827-6210.

I. Background

    The guidance document is intended to provide guidance to those 
involved in designing clinical studies that support premarket 
submissions for medical devices and FDA staff who review those 
submissions. Although the Agency has articulated policies related to 
design of studies intended to support specific device types, and a 
general policy of tailoring the evidentiary burden to the regulatory 
requirement, the Agency has not attempted to describe the different 
clinical study designs that may be appropriate to support a device 
premarket submission, or to define how a sponsor should decide which 
pivotal clinical study design should be used to support a submission 
for a particular device. The guidance document describes different 
study design principles relevant to the development of medical device 
clinical studies that can be used to fulfill premarket clinical data 
requirements. The guidance is not intended to provide a comprehensive 
tutorial on the best clinical and statistical practices for 
investigational medical device studies.
    A medical device pivotal study is a definitive study in which 
evidence is gathered to support the safety and effectiveness evaluation 
of the medical device for its intended use. Evidence from one or more 
pivotal clinical studies generally serves as the primary basis for the 
determination of reasonable assurance of safety and effectiveness of 
the medical device of a premarket approval application (PMA) and FDA's 
overall risk-benefit assessment. In some cases, a PMA may include 
multiple studies designed to answer different scientific questions.
    The guidance describes principles that should be followed for the 
design of premarket clinical studies that are pivotal in establishing 
the safety and effectiveness of a medical device. Practical issues and 
pitfalls in pivotal clinical study design are discussed, along with 
their effects on the conclusions that can be drawn from the studies 
concerning safety and effectiveness.
    In the Federal Register of August 15, 2011 (76 FR 50484), FDA 
announced the availability of the draft guidance. Interested persons 
were invited to comment by November 14, 2011. FDA considered the 
comments and revised the guidance, as appropriate.

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 pivotal clinical investigations for 
medical devices. 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.fda.gov/BiologicsBloodVaccines/GuidanceComplianceRegulatoryInformation/default.htm or http://www.regulations.gov. To receive ``Device 
Considerations for Pivotal Clinical Investigations for Medical 
Devices,'' 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 
1776 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 807, subpart E have been 
approved under 0910-0120; the collections of information in 21 CFR part 
812 have been approved under 0910-0078; the collections of information 
in 21 CFR part 814 have been approved under 0910-0231.

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: November 1, 2013.
Leslie Kux,
Assistant Commissioner for Policy.
[FR Doc. 2013-26690 Filed 11-6-13; 8:45 am]
BILLING CODE 4160-01-P


