80 FR 28276 - Adaptive Designs for Medical Device Clinical Studies; Draft Guidance for Industry and Food and Drug Administration Staff; Availability

DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration

Federal Register Volume 80, Issue 95 (May 18, 2015)

The Food and Drug Administration (FDA) is announcing the availability of the draft guidance entitled ``Adaptive Designs for Medical Device Clinical Studies; Draft Guidance for Industry and Food and Drug Administration Staff.'' This guidance provides sponsors and FDA staff with guidance on how to plan and implement adaptive designs for clinical studies when used in medical device development programs. An adaptive design for a medical device clinical study is defined as a clinical trial design that allows for prospectively planned modifications based on accumulating study data without undermining the trial's integrity and validity. Adaptive designs, when properly implemented, can reduce resource requirements and/or increase the chance of study success. This draft guidance is not final nor is it in effect at this time.

[Federal Register Volume 80, Number 95 (Monday, May 18, 2015)]
[Notices]
[Pages 28276-28277]
From the Federal Register Online  [www.thefederalregister.org]
[FR Doc No: 2015-11820]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2015-D-1439]


Adaptive Designs for Medical Device Clinical Studies; Draft 
Guidance for Industry and Food and Drug Administration Staff; 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availability of the draft guidance entitled ``Adaptive Designs for 
Medical Device Clinical Studies; Draft Guidance for Industry and Food 
and Drug Administration Staff.'' This guidance provides sponsors and 
FDA staff with guidance on how to plan and implement adaptive designs 
for clinical studies when used in medical device development programs. 
An adaptive design for a medical device clinical study is defined as a 
clinical trial design that allows for prospectively planned 
modifications based on accumulating study data without undermining the 
trial's integrity and validity. Adaptive designs, when properly 
implemented, can reduce resource requirements and/or increase the 
chance of study success. This draft guidance is not final nor is it in 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 of 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 August 17, 2015.

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 draft guidance document entitled 
``Adaptive Designs for Medical Device Clinical Studies; Draft Guidance 
for Industry and Food and Drug Administration Staff'' 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. 
Send one self-addressed adhesive label to assist that office in 
processing your request.
    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.

SUPPLEMENTARY INFORMATION: 

I. Background

    This guidance provides sponsors and FDA staff with guidance on how 
to plan and implement adaptive designs for clinical studies when used 
in medical device development programs. This document addresses 
adaptive designs for medical device clinical trials and is applicable 
to premarket medical device submissions including premarket approval 
applications, premarket notification (510(k)) submissions, de novo 
submissions (evaluation of automatic class III designation), 
humanitarian device exemption applications, and investigational device 
exemption submissions. This guidance can be applied throughout the 
clinical development program of a medical device, from feasibility 
studies to pivotal clinical trials. This guidance does not apply to 
clinical studies of combination products or codevelopment of a 
pharmaceutical product with an unapproved diagnostic test.

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 current thinking of FDA on the adaptive 
design of clinical

[[Page 28277]]

studies for medical devices. It does not establish any rights for any 
person and is not binding on FDA or the public. You can use an 
alternative approach if it 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 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. Persons 
unable to download an electronic copy of ``Adaptive Designs for Medical 
Device Clinical Studies; Draft Guidance for Industry and Food and Drug 
Administration Staff'' may send an email request to [email protected] to receive an electronic copy of the document. 
Please use the document number GUD1500005 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, which have 
been approved under 0910-0120; 21 CFR part 812, which have been 
approved under 0910-0078; 21 CFR part 814, subparts A, B, and C, which 
have been approved under OMB control number 0910-0231; and 21 CFR part 
814, subpart H, which have been approved under OMB control number 0910-
0332.

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: May 12, 2015.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2015-11820 Filed 5-15-15; 8:45 am]
 BILLING CODE 4164-01-P