[Federal Register Volume 76, Number 157 (Monday, August 15, 2011)]
[Notices]
[Pages 50484-50485]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2011-20603]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

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


Draft Guidance for Industry, Clinical Investigators, and Food and 
Drug Administration Staff; Design Considerations for Pivotal Clinical 
Investigations for Medical Devices; 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availability of the draft guidance entitled ``Design Considerations for 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. This draft guidance is not final 
nor is it in effect at this time.

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draft guidance before it begins work on the final version of the 
guidance, submit either electronic or written comments on the draft 
guidance by November 14, 2011.

ADDRESSES: Submit written requests for single copies of the draft 
guidance document entitled ``Design Considerations for Pivotal Clinical 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 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:  Greg 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.

[[Page 50485]]

    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, 301-827-6210.

SUPPLEMENTARY INFORMATION: 

I. Background

    This draft guidance 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. 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 draft 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 draft 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 draft 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.

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 design 
considerations for 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 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 from CBER at http://www.fda.gov/BiologicsBloodVaccines/GuidanceComplianceRegulatoryInformation/default.htm or on the Division of Dockets Management Internet site at 
http://www.regulations.gov. To receive ``Design Considerations for 
Pivotal Clinical Investigations for Medical Devices,'' you may either 
send an e-mail 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 1776 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 807, subpart E have been 
approved under OMB control number 0910-0120; the collections of 
information in 21 CFR part 812 have been approved under OMB control 
number 0910-0078; the collections of information in 21 CFR part 814 
have been approved under OMB control number 0910-0231.

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: August 9, 2011.
Nancy K. Stade,
Deputy Director for Policy, Center for Devices and Radiological Health.
[FR Doc. 2011-20603 Filed 8-12-11; 8:45 am]
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