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Notice2022-09738

Feasibility and Early Feasibility Clinical Studies for Certain Medical Devices Intended to Therapeutically Improve Glycemic Control in Patients With Type 2 Diabetes Mellitus; Guidance for Industry and Food and Drug Administration Staff; Availability

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Published
May 6, 2022

Issuing agencies

Health and Human Services DepartmentFood and Drug Administration

Abstract

The Food and Drug Administration (FDA or Agency) is announcing the availability of a final guidance entitled "Feasibility and Early Feasibility Clinical Studies for Certain Medical Devices Intended to Therapeutically Improve Glycemic Control in Patients with Type 2 Diabetes Mellitus." This guidance provides recommendations for feasibility and early feasibility clinical studies for certain medical devices intended to therapeutically improve glycemic control in patients with Type 2 Diabetes Mellitus. These medical devices are intended to therapeutically reduce glycated hemoglobin in Type 2 Diabetes Mellitus patients independent of medication (e.g., insulin) delivery.

Full Text

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<title>Federal Register, Volume 87 Issue 88 (Friday, May 6, 2022)</title>
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[Federal Register Volume 87, Number 88 (Friday, May 6, 2022)]
[Notices]
[Pages 27170-27172]
From the Federal Register Online via the Government Publishing Office [<a href="http://www.gpo.gov">www.gpo.gov</a>]
[FR Doc No: 2022-09738]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2021-D-0131]


Feasibility and Early Feasibility Clinical Studies for Certain 
Medical Devices Intended to Therapeutically Improve Glycemic Control in 
Patients With Type 2 Diabetes Mellitus; 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 a final guidance entitled ``Feasibility and Early 
Feasibility Clinical Studies for Certain Medical Devices Intended to 
Therapeutically Improve Glycemic Control in Patients with Type 2 
Diabetes Mellitus.'' This guidance provides recommendations for 
feasibility and early feasibility clinical studies for certain medical 
devices intended to therapeutically improve glycemic control in 
patients with Type 2 Diabetes Mellitus. These medical devices are 
intended to therapeutically reduce glycated hemoglobin in Type 2 
Diabetes Mellitus patients independent of medication (e.g., insulin) 
delivery.

DATES: The announcement of the guidance is published in the Federal 
Register on May 6, 2022.

ADDRESSES: You may submit either electronic or written comments on 
Agency guidances at any time as follows:

Electronic Submissions

    Submit electronic comments in the following way:
    <bullet> Federal eRulemaking Portal: <a href="https://www.regulations.gov">https://www.regulations.gov</a>. 
Follow the instructions for submitting comments. Comments submitted 
electronically, including attachments, to <a href="https://www.regulations.gov">https://www.regulations.gov</a> 
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

[[Page 27171]]

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 <a href="https://www.regulations.gov">https://www.regulations.gov</a>.
    <bullet> 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:
    <bullet> Mail/Hand Delivery/Courier (for written/paper 
submissions): Dockets Management Staff (HFA-305), Food and Drug 
Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852.
    <bullet> For written/paper comments submitted to the Dockets 
Management Staff, 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-2021-D-0131 for ``Feasibility and Early Feasibility Clinical 
Studies for Certain Medical Devices Intended to Therapeutically Improve 
Glycemic Control in Patients with Type 2 Diabetes Mellitus.'' Received 
comments will be placed in the docket and, except for those submitted 
as ``Confidential Submissions,'' publicly viewable at <a href="https://www.regulations.gov">https://www.regulations.gov</a> or at the Dockets Management Staff between 9 a.m. 
and 4 p.m., Monday through Friday, 240-402-7500.
    <bullet> 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 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 <a href="https://www.regulations.gov">https://www.regulations.gov</a>. 
Submit both copies to the Dockets Management Staff. 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: <a href="https://www.govinfo.gov/content/pkg/FR-2015-09-18/pdf/2015-23389.pdf">https://www.govinfo.gov/content/pkg/FR-2015-09-18/pdf/2015-23389.pdf</a>.
    Docket: For access to the docket to read background documents or 
the electronic and written/paper comments received, go to <a href="https://www.regulations.gov">https://www.regulations.gov</a> 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 Dockets Management Staff, 5630 Fishers Lane, 
Rm. 1061, Rockville, MD 20852, 240-402-7500.
    You may submit comments on any guidance at any time (see 21 CFR 
10.115(g)(5)).
    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 
``Feasibility and Early Feasibility Clinical Studies for Certain 
Medical Devices Intended to Therapeutically Improve Glycemic Control in 
Patients with Type 2 Diabetes Mellitus'' to the Office of Policy, 
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.

FOR FURTHER INFORMATION CONTACT: April Marrone, Center for Devices and 
Radiological Health, Food and Drug Administration, 10903 New Hampshire 
Ave., Bldg. 66, Rm. 2604, Silver Spring, MD 20993-0002, 240-402-6510.

SUPPLEMENTARY INFORMATION:

I. Background

    This guidance provides recommendations for the design of 
feasibility and early feasibility clinical studies for certain medical 
devices intended to therapeutically improve glycemic control in 
patients with Type 2 Diabetes Mellitus (T2DM). T2DM is a metabolic 
disorder that is characterized by high blood sugar levels, insulin 
resistance, and relative lack of insulin. In 2020, it was estimated 
that 10.5 percent of the United States population, or roughly 34.2 
million Americans, have diabetes and that T2DM accounts for 90 percent 
to 95 percent of all diabetes cases.\1\
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    \1\ Center for Disease Control, National Diabetes Statistics 
Report 2020: Estimates of Diabetes and its Burden in the United 
States, available at <a href="https://www.cdc.gov/diabetes/pdfs/data/statistics/national-diabetes-statistics-report.pdf">https://www.cdc.gov/diabetes/pdfs/data/statistics/national-diabetes-statistics-report.pdf</a>.
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    Due to the prevalence of T2DM in the United States, many medical 
device manufacturers and researchers seek to develop therapeutic 
medical devices that are intended to improve glycemic control in 
patients with T2DM. Historically, there have been several legally 
marketed devices that help patients manage T2DM, including medical 
devices intended to measure or monitor blood sugar (e.g., blood glucose 
monitors, continuous glucose monitors) or dose and deliver insulin 
(e.g., insulin pens, pumps, syringes). Medical devices that are 
therapeutically intended to improve glycemic control in patients with 
T2DM are an increasing area of interest. Manufacturers frequently 
request the Agency's feedback regarding feasibility and early 
feasibility clinical studies for these medical devices. This guidance 
represents the Agency's initial thinking on feasibility and early 
feasibility clinical studies for these medical devices. FDA's 
recommendations may change as more information becomes available.
    A notice of availability of the draft guidance appeared in the 
Federal Register of May 20, 2021 (86 FR 27438). FDA considered comments 
received and revised the guidance as appropriate in response to the 
comments, including revisions to clarify the scope of devices included 
in the guidance and revisions to clarify or provide examples of certain 
terminology used in the 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 feasibility and early feasibility clinical 
studies for certain medical devices intended to therapeutically improve 
glycemic control in patients with T2DM. 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.

II. 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

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Health guidance documents is available at <a href="https://www.fda.gov/medical-devices/device-advice-comprehensive-regulatory-assistance/guidance-documents-medical-devices-and-radiation-emitting-products">https://www.fda.gov/medical-devices/device-advice-comprehensive-regulatory-assistance/guidance-documents-medical-devices-and-radiation-emitting-products</a>. This 
guidance is also available at <a href="https://www.regulations.gov">https://www.regulations.gov</a>, <a href="https://www.fda.gov/regulatory-information/search-fda-guidance-documents">https://www.fda.gov/regulatory-information/search-fda-guidance-documents</a>. 
Persons unable to download an electronic copy of ``Feasibility and 
Early Feasibility Clinical Studies for Certain Medical Devices Intended 
to Therapeutically Improve Glycemic Control in Patients with Type 2 
Diabetes Mellitus'' may send an email request to <a href="/cdn-cgi/l/email-protection#0d4e495f45204a7864696c636e684d6b696c2365657e236a627b"><span class="__cf_email__" data-cfemail="6b282f3923462c1e020f0a05080e2b0d0f0a45030318450c041d">[email&#160;protected]</span></a> to receive an electronic copy of the document. 
Please use the document number 19045 and complete title to identify the 
guidance you are requesting.

III. Paperwork Reduction Act of 1995

    While this guidance contains no new collection of information, it 
does refer to previously approved FDA collections of information. 
Therefore, clearance by the Office of Management and Budget (OMB) under 
the Paperwork Reduction Act of 1995 (PRA) (44 U.S.C. 3501-3521) is not 
required for this guidance. The previously approved collections of 
information are subject to review by OMB under the PRA. The collections 
of information in the following FDA regulations and guidances have been 
approved by OMB as listed in the following table:

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    21 CFR part or guidance             Topic           OMB control No.
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807, subpart E................  Premarket                      0910-0120
                                 Notification.
814, subparts A through E.....  Premarket Approval...          0910-0231
812...........................  Investigational                0910-0078
                                 Device Exemption.
``Requests for Feedback on      Q-submissions; Pre-            0910-0756
 Medical Device Submissions:     submissions.
 The Q-Submission Program''.
50, 56........................  Protection of Human            0910-0130
                                 Subjects and
                                 Institutional Review
                                 Boards.
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    Dated: April 28, 2022.
Lauren K. Roth,
Associate Commissioner for Policy.
[FR Doc. 2022-09738 Filed 5-5-22; 8:45 am]
BILLING CODE 4164-01-P


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