[Federal Register Volume 86, Number 96 (Thursday, May 20, 2021)]
[Notices]
[Pages 27438-27440]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2021-10599]


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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Patients With Type 2 Diabetes Mellitus; Draft Guidance for Industry and 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the availability of the draft guidance entitled ``Feasibility and Early 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 This draft guidance provides recommendations for 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. This draft guidance is not final nor is it in effect at this 
time.

DATES: Submit either electronic or written comments on the draft 
guidance by July 19, 2021 to ensure that the Agency considers your 
comment on this draft guidance before it begins work on the final 
version of the guidance.

ADDRESSES: You may submit comments on any guidance at any time as 
follows:

Electronic Submissions

    Submit electronic comments in the following way:
     Federal eRulemaking Portal: https://www.regulations.gov. 
Follow the instructions for submitting comments. Comments submitted 
electronically, including attachments, to https://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 https://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): Dockets Management Staff (HFA-305), Food and Drug 
Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852.
     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-

[[Page 27439]]

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 https://www.regulations.gov or at the Dockets Management Staff between 9 a.m. 
and 4 p.m., Monday through Friday, 240-402-7500.
     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 https://www.regulations.gov. 
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: https://www.govinfo.gov/content/pkg/FR-2015-09-18/pdf/2015-23389.pdf.
    Docket: For access to the docket to read background documents or 
the electronic and written/paper comments received, go to https://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 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 draft 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, 
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.

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 draft 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 is estimated that 
10.5 percent of the U.S. 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 https://www.cdc.gov/diabetes/pdfs/data/statistics/national-diabetes-statistics-report.pdf.
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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. While there are 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), there are currently no legally marketed medical 
devices in the United States that are intended to therapeutically 
improve glycemic control in patients with T2DM.
    In recent years, medical devices that are therapeutically intended 
to improve glycemic control in patients with T2DM have become an 
increasing area of interest, and manufacturers have requested the 
Agency's feedback regarding feasibility and early feasibility clinical 
studies for these medical devices. This draft 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.
    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 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 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 https://www.fda.gov/medical-devices/device-advice-comprehensive-regulatory-assistance/guidance-documents-medical-devices-and-radiation-emitting-products. This draft guidance document 
is also available at https://www.regulations.gov and at https://www.fda.gov/regulatory-information/search-fda-guidance-documents. 
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 [email protected] 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 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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                                                           OMB  control
    21 CFR part or guidance               Topic                 No.
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807, subpart E.................  Premarket notification.       0910-0120
814, subparts A through E......  Premarket approval.....       0910-0231
812............................  Investigational Device        0910-0078
                                  Exemption.
``Requests for Feedback on       Q-submissions..........       0910-0756
 Medical Device Submissions:
 The Pre-Submission Program and
 Meetings with Food and Drug
 Administration Staff''.
50, 56.........................  Protection of Human           0910-0755
                                  Subjects: Informed
                                  Consent; Institutional
                                  Review Boards.
56.............................  Institutional Review          0910-0130
                                  Boards.
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    Dated: May 14, 2021.
Lauren K. Roth,
Acting Principal Associate Commissioner for Policy.
[FR Doc. 2021-10599 Filed 5-19-21; 8:45 am]
BILLING CODE 4164-01-P