81 FR 49230 - Adaptive Designs for Medical Device Clinical Studies; Guidance for Industry and Food and Drug Administration Staff; Availability

DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration

Federal Register Volume 81, Issue 144 (July 27, 2016)

The Food and Drug Administration (FDA or Agency) is announcing the availability of the guidance entitled ``Adaptive Designs for Medical Device Clinical Studies.'' 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.

[Federal Register Volume 81, Number 144 (Wednesday, July 27, 2016)]
[Notices]
[Pages 49230-49231]
From the Federal Register Online  [www.thefederalregister.org]
[FR Doc No: 2016-17651]


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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; Guidance 
for Industry and Food and Drug Administration Staff; Availability

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice of availability.

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SUMMARY: The Food and Drug Administration (FDA or Agency) is announcing 
the availability of the guidance entitled ``Adaptive Designs for 
Medical Device Clinical Studies.'' 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.

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: You may submit comments as follows:

Electronic Submissions

    Submit electronic comments in the following way:
     Federal eRulemaking Portal: http://www.regulations.gov. 
Follow the instructions for submitting comments. Comments submitted 
electronically, including attachments, to http://www.regulations.gov 
will be posted to the docket unchanged. Because your comment will be 
made public, you are solely responsible for ensuring that your comment 
does not include any confidential information that you or a third party 
may not wish to be posted, such as medical information, your or anyone 
else's Social Security number, or confidential business information, 
such as a manufacturing process. Please note that if you include your 
name, contact information, or other information that identifies you in 
the body of your comments, that information will be posted on http://www.regulations.gov.
     If you want to submit a comment with confidential 
information that you do not wish to be made available to the public, 
submit the comment as a written/paper submission and in the manner 
detailed (see ``Written/Paper Submissions'' and ``Instructions'').

Written/Paper Submissions

    Submit written/paper submissions as follows:
     Mail/Hand delivery/Courier (for written/paper 
submissions): Division of Dockets Management (HFA-305), Food and Drug 
Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852.
     For written/paper comments submitted to the Division of 
Dockets Management, FDA will post your comment, as well as any 
attachments, except for information submitted, marked, and identified, 
as confidential, if submitted as detailed in ``Instructions.''
    Instructions: All submissions received must include the Docket No. 
FDA-2015-D-1439 for ``Adaptive Designs for Medical Device Clinical 
Studies.'' Received comments will be placed in the docket and, except 
for those submitted as ``Confidential Submissions,'' publicly viewable 
at http://www.regulations.gov or at the Division of Dockets Management 
between 9 a.m. and 4 p.m., Monday through Friday.
     Confidential Submissions--To submit a comment with 
confidential information that you do not wish to be made publicly 
available, submit your comments only as a written/paper submission. You 
should submit two

[[Page 49231]]

copies total. One copy will include the information you claim to be 
confidential with a heading or cover note that states ``THIS DOCUMENT 
CONTAINS CONFIDENTIAL INFORMATION.'' The Agency will review this copy, 
including the claimed confidential information, in its consideration of 
comments. The second copy, which will have the claimed confidential 
information redacted/blacked out, will be available for public viewing 
and posted on http://www.regulations.gov. Submit both copies to the 
Division of Dockets Management. If you do not wish your name and 
contact information to be made publicly available, you can provide this 
information on the cover sheet and not in the body of your comments and 
you must identify this information as ``confidential.'' Any information 
marked as ``confidential'' will not be disclosed except in accordance 
with 21 CFR 10.20 and other applicable disclosure law. For more 
information about FDA's posting of comments to public dockets, see 80 
FR 56469, September 18, 2015, or access the information at: http://www.fda.gov/regulatoryinformation/dockets/default.htm.
    Docket: For access to the docket to read background documents or 
the electronic and written/paper comments received, go to http://www.regulations.gov and insert the docket number, found in brackets in 
the heading of this document, into the ``Search'' box and follow the 
prompts and/or go to the Division of Dockets Management, 5630 Fishers 
Lane, Rm. 1061, Rockville, MD 20852.
    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 
``Adaptive Designs for Medical Device Clinical Studies'' 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.

FOR FURTHER INFORMATION CONTACT: Gerry Gray, Center for Devices and 
Radiological Health, Food and Drug Administration, 10903 New Hampshire 
Ave., Bldg. 66, Rm. 2112, Silver Spring, MD 20993-0002, 301-796-6012; 
or the Division of Biostatistics, Center for Devices and Radiological 
Health, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 
66, Silver Spring, MD 20993-0002, 301-796-5750; 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

    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 (PMA), premarket notification (510(k)) submissions, de 
novo submissions (evaluation of automatic class III designation), 
humanitarian device exemption (HDE) applications, and investigational 
device exemption (IDE) 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. The draft 
guidance was available from May 18, 2015, to August 17, 2015. FDA 
received 151 comments from seven entities and has incorporated most of 
them in this final guidance.

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 
current thinking of FDA on ``Adaptive Designs for Medical Device 
Clinical Studies.'' 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 statutes 
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.fda.gov/BiologicsBloodVaccines/GuidanceComplianceRegulatoryInformation/default.htm or http://www.regulations.gov. Persons unable to download 
an electronic copy of ``Adaptive Designs for Medical Device Clinical 
Studies'' 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 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, 
subparts A through E, have been approved under OMB control number 0910-
0231; the collections of information in 21 CFR part 814,subpart H, have 
been approved under OMB control number 0910-0332; and the collections 
of information in the guidance document ``Requests for Feedback on 
Medical Device Submissions: The Pre-Submission Program and Meetings 
with Food and Drug Administration Staff'' have been approved under OMB 
control number 0910-0756.

    Dated: July 21, 2016.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2016-17651 Filed 7-26-16; 8:45 am]
 BILLING CODE 4164-01-P