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Certain Medical Devices Intended to Therapeutically Improve Glycemic Control in Patients With Type 2 Diabetes Mellitus; Draft Guidance for Industry and Food and Drug Administration Staff; Availability, 27438-27440 [2021-10599]

Download as PDF 27438 Federal Register / Vol. 86, No. 96 / Thursday, May 20, 2021 / Notices Ave., Bldg. 66, Rm. 5510, Silver Spring, MD 20993–0002, 301–796–4539. SUPPLEMENTARY INFORMATION: I. Background FDA is announcing the availability of a draft guidance for industry entitled ‘‘ICH Q12: Implementation Considerations for FDA-Regulated Products.’’ ICH Q12 provides a framework to facilitate the management of postapproval CMC changes in a more predictable and efficient manner. It includes regulatory tools and enablers with associated guiding principles that should enhance industry’s ability to manage postapproval changes and increase transparency between industry and regulatory authorities, supporting innovation and continual improvement. This guidance should be read in conjunction with ICH Q12, which this guidance complements by clarifying how the ICH Q12 tools and enablers can be implemented within the U.S. regulatory system. These guidances apply to drug substances and drug products that are the subject of new drug applications (NDAs), biologics license applications (BLAs), abbreviated new drug applications (ANDAs), and supplements to these applications regulated by CDER and CBER. They also apply to combination products with device constituent parts that are the subject of NDAs, BLAs, ANDAs, and supplements to these applications regulated by CDER and CBER. This guidance provides considerations for implementation of ICH Q12 tools, such as established conditions, postapproval change management protocols, and the product lifecycle management document. The considerations provided follow the order of the sections in ICH Q12 and are specific to FDA’s implementation. This draft guidance is being issued consistent with FDA’s good guidance practices regulation (21 CFR 10.115). The draft guidance, when finalized, will represent the current thinking of FDA on ‘‘ICH Q12: Implementation Considerations for FDA-Regulated Products.’’ 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. 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– VerDate Sep<11>2014 17:36 May 19, 2021 Jkt 253001 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 for the submission of NDAs and ANDAs in 21 CFR 314.50, 314.70, 314.71, 314.94, and 314.97, including supplements, have been approved under OMB control number 0910–0001. The collections of information in 21 CFR parts 210 and 211 have been approved under OMB control number 0910–0139. The collections of information for the submission of BLAs under 21 CFR 601.2 and 601.12 have been approved under OMB control number 0910–0338. III. Electronic Access Persons with access to the internet may obtain the draft guidance at https:// www.fda.gov/drugs/guidancecompliance-regulatory-information/ guidances-drugs, https://www.fda.gov/ vaccines-blood-biologics/guidancecompliance-regulatory-informationbiologics/biologics-guidances, https:// www.fda.gov/medical-devices/deviceadvice-comprehensive-regulatoryassistance/guidance-documentsmedical-devices-and-radiation-emittingproducts, or https:// www.regulations.gov. Dated: May 14, 2021. Lauren K. Roth, Acting Principal Associate Commissioner for Policy. [FR Doc. 2021–10611 Filed 5–19–21; 8:45 am] BILLING CODE 4164–01–P 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. 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 SUMMARY: PO 00000 Frm 00075 Fmt 4703 Sfmt 4703 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– E:\FR\FM\20MYN1.SGM 20MYN1 Federal Register / Vol. 86, No. 96 / Thursday, May 20, 2021 / Notices 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-201509-18/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 VerDate Sep<11>2014 17:36 May 19, 2021 Jkt 253001 27439 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: 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. 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 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 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-comprehensiveregulatory-assistance/guidancedocuments-medical-devices-andradiation-emitting-products. This draft guidance document is also available at https://www.regulations.gov and at https://www.fda.gov/regulatoryinformation/search-fda-guidancedocuments. 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 CDRH-Guidance@fda.hhs.gov to receive an electronic copy of the document. Please use the document number 19045 and complete title to identify the guidance you are requesting. 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. PO 00000 Frm 00076 Fmt 4703 Sfmt 4703 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: E:\FR\FM\20MYN1.SGM 20MYN1 27440 Federal Register / Vol. 86, No. 96 / Thursday, May 20, 2021 / Notices OMB control No. 21 CFR part or guidance Topic 807, subpart E ............................................................................ 814, subparts A through E .......................................................... 812 .............................................................................................. ‘‘Requests for Feedback on Medical Device Submissions: The Pre-Submission Program and Meetings with Food and Drug Administration Staff’’. 50, 56 .......................................................................................... Premarket notification ................................................................ Premarket approval .................................................................... Investigational Device Exemption .............................................. Q-submissions ........................................................................... 0910–0120 0910–0231 0910–0078 0910–0756 Protection of Human Subjects: Informed Consent; Institutional Review Boards. Institutional Review Boards ....................................................... 0910–0755 56 ................................................................................................ 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 DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA–2021–N–0033] Morton Grove Pharmaceuticals Inc. et al.; Withdrawal of Approval of Seven Abbreviated New Drug Applications; Correction AGENCY: Food and Drug Administration, HHS. ACTION: Notice; correction. The Food and Drug Administration (FDA) is correcting a notice that appeared in the Federal Register of March 5, 2021. The document announced the withdrawal of approval of seven abbreviated new drug applications (ANDAs) from multiple applicants as of April 5, 2021. The document indicated that FDA was withdrawing approval of the following five ANDAs, after receiving a withdrawal request from Neopharma, Inc., 211 College Road East, Suite 101, Princeton, NJ 08540: ANDA 078383, Pioglitazone Hydrochloride (HCl) Tablets, Equivalent to (EQ) 15 milligrams (mg) base, EQ 30 mg base, and EQ 45 mg base; ANDA 078953, Irinotecan HCl Injection, 40 mg/2 milliliters (mL) (20 mg/mL) and 100 mg/ 5 mL (20 mg/mL); ANDA 079049, Alendronate Sodium Tablets, EQ 5 mg base, EQ 10 mg base, EQ 35 mg base, and EQ 70 mg base; ANDA 090732, Anastrozole Tablets, 1 mg; and ANDA 203161, Irbesartan Tablets, 75 mg, 150 mg, and 300 mg. Before FDA withdrew the approval of these ANDAs, Neopharma, Inc., informed FDA that it did not want the approval of the ANDAs withdrawn. Because Neopharma, Inc., timely requested that approval of these ANDAs not be withdrawn, the approval SUMMARY: VerDate Sep<11>2014 17:36 May 19, 2021 Jkt 253001 of ANDAs 078383, 078953, 079049, 090732, and 203161 is still in effect. FOR FURTHER INFORMATION CONTACT: Martha Nguyen, Center for Drug Evaluation and Research, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 75, Rm. 1676, Silver Spring, MD 20993–0002, 240– 402–6980, Martha.Nguyen@fda.hhs.gov. SUPPLEMENTARY INFORMATION: In the Federal Register of Friday, March 5, 2021 (86 FR 12950), appearing on page 12950 in FR Doc. 2021–04520, the following corrections are made on pages 12950 and 12951 in the table: The entries for ANDAs 078383, 078953, 079049, 090732, and 203161 are removed. Dated: May 14, 2021. Lauren K. Roth, Acting Principal Associate Commissioner for Policy. [FR Doc. 2021–10588 Filed 5–19–21; 8:45 am] BILLING CODE 4164–01–P DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA–2021–P–0162] Determination That NORMODYNE (Labetalol Hydrochloride) Injection, 5 Milligrams per Milliliter, Was Not Withdrawn From Sale for Reasons of Safety or Effectiveness AGENCY: Food and Drug Administration, HHS. ACTION: Notice. The Food and Drug Administration (FDA or Agency) has determined that NORMODYNE (labetalol hydrochloride) injection, 5 milligrams per milliliter (mg/mL), was not withdrawn from sale for reasons of safety or effectiveness. This determination means that FDA will not begin procedures to withdraw approval of abbreviated new drug applications (ANDAs) that refer to this drug product, and it will allow FDA to continue to approve ANDAs that refer to the SUMMARY: PO 00000 Frm 00077 Fmt 4703 Sfmt 4703 0910–0130 product as long as they meet relevant legal and regulatory requirements. FOR FURTHER INFORMATION CONTACT: Christopher Koepke, Center for Drug Evaluation and Research, Food and Drug Administration, 10903 New Hampshire Ave., Silver Spring, MD 20993–0002, 301–796–3600, Christopher.Koepke@fda.hhs.gov. SUPPLEMENTARY INFORMATION: In 1984, Congress enacted the Drug Price Competition and Patent Term Restoration Act of 1984 (Pub. L. 98–417) (the 1984 amendments), which authorized the approval of duplicate versions of drug products under an ANDA procedure. ANDA applicants must, with certain exceptions, show that the drug for which they are seeking approval contains the same active ingredient in the same strength and dosage form as the ‘‘listed drug,’’ which is a version of the drug that was previously approved. ANDA applicants do not have to repeat the extensive clinical testing otherwise necessary to gain approval of a new drug application (NDA). The 1984 amendments include what is now section 505(j)(7) of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 355(j)(7)), which requires FDA to publish a list of all approved drugs. FDA publishes this list as part of the ‘‘Approved Drug Products With Therapeutic Equivalence Evaluations,’’ which is known generally as the ‘‘Orange Book.’’ Under FDA regulations, drugs are removed from the list if the Agency withdraws or suspends approval of the drug’s NDA or ANDA for reasons of safety or effectiveness or if FDA determines that the listed drug was withdrawn from sale for reasons of safety or effectiveness (21 CFR 314.162). A person may petition the Agency to determine, or the Agency may determine on its own initiative, whether a listed drug was withdrawn from sale for reasons of safety or effectiveness. This determination may be made at any time after the drug has been withdrawn from sale, but must be made prior to approving an ANDA that refers to the listed drug (§ 314.161 (21 CFR 314.161)). E:\FR\FM\20MYN1.SGM 20MYN1

Agencies

[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]


-----------------------------------------------------------------------

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.

-----------------------------------------------------------------------

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\
---------------------------------------------------------------------------

    \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.
---------------------------------------------------------------------------

    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:

[[Page 27440]]



------------------------------------------------------------------------
                                                           OMB  control
    21 CFR part or guidance               Topic                 No.
------------------------------------------------------------------------
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.
------------------------------------------------------------------------


    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
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