83 FR 61648 - Blood Glucose Monitoring Test Systems for Prescription Point-of-Care Use; Draft Guidance for Industry and Food and Drug Administration Staff; Availability
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration Federal Register Volume 83, Issue 231 (November 30, 2018)
Food and Drug Administration
Federal Register Volume 83, Issue 231 (November 30, 2018)
| Page Range | 61648-61650 | |
| FR Document | 2018-26034 |
[Federal Register Volume 83, Number 231 (Friday, November 30, 2018)] [Notices] [Pages 61648-61650] From the Federal Register Online [www.thefederalregister.org] [FR Doc No: 2018-26034] ----------------------------------------------------------------------- DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2013-D-1445] Blood Glucose Monitoring Test Systems for Prescription Point-of- Care Use; Draft Guidance for Industry and Food and Drug Administration Staff; Availability AGENCY: Food and Drug Administration, HHS.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SUMMARY: The Food and Drug Administration (FDA or Agency) is announcing the availability of the draft guidance for industry and FDA staff entitled ``Blood Glucose Monitoring Test Systems for Prescription Point-of-Care Use.'' This draft guidance document describes studies and criteria that FDA recommends be used when submitting premarket notifications (510(k)s) for blood glucose monitoring systems (BGMSs) that are for prescription point-of-care use. This draft guidance is not final nor is it in effect at this time. DATES: Submit either electronic or written comments on the draft guidance by February 28, 2019 to ensure that the Agency considers your comment on this draft guidance before it begins work on the final version of the guidance.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 [[Page 61649]] information submitted, marked and identified, as confidential, if submitted as detailed in ``Instructions.'' Instructions: All submissions received must include the Docket No. FDA-2013-D-1445 for ``Blood Glucose Monitoring Test Systems for Prescription Point-of-Care Use.'' 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. 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.thefederalregister.org/fdsys/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. You may submit comments on any guidance at any time (see 21 CFR 10.115(g)(5)). An electronic copy of the draft guidance document is available for download from the internet. See the SUPPLEMENTARY INFORMATION section for information on electronic access to the draft guidance. Submit written requests for a single hard copy of the draft guidance document entitled ``Blood Glucose Monitoring Test Systems for Prescription Point-of-Care Use'' 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. FOR FURTHER INFORMATION CONTACT: Leslie Landree, Center for Devices and Radiological Health, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 66, Rm. 4623, Silver Spring, MD 20993-0002, 301-796-6147. SUPPLEMENTARY INFORMATION: I. Background On October 11, 2016, FDA published a final guidance entitled, ``Blood Glucose Monitoring Test Systems for Prescription Point-of-Care Use.'' That guidance document described studies and information that FDA recommends be used when submitting 510(k)s for BGMSs that are for prescription point-of-care use. FDA is now proposing to make modifications to the guidance based on feedback received from stakeholders, which the Agency believes will better align with the evolving understanding and development of these types of devices. When finalized, this draft guidance will replace the final guidance of the same title issued on October 11, 2016. 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 ``Blood Glucose Monitoring Test Systems for Prescription Point-of-Care Use.'' 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. This guidance is not subject to Executive Order 12866. 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 https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/GuidanceDocuments/default.htm. This draft guidance document is also available at https://www.regulations.gov. Persons unable to download an electronic copy of ``Blood Glucose Monitoring Test Systems for Prescription Point-of-Care Use'' may send an email request to CDRH-Guidance@fda.hhs.gov to receive an electronic copy of the document. Please use the document number GUD 1755 to identify the guidance you are requesting. IV. Paperwork Reduction Act of 1995 This draft guidance refers to previously approved collections of information. 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 the following FDA guidances and regulations have been approved by OMB as listed in the following table: ------------------------------------------------------------------------ OMB Control 21 CFR part or guidance Topic No. ------------------------------------------------------------------------ 807, subpart E.................... Premarket 0910-0120 Notification. ``Requests for Feedback on Medical Q-Submissions....... 0910-0756 Device Submissions: The Pre- Submission Program and Meetings with Food and Drug Administration Staff``. 800, 801, and 809................. Medical Device 0910-0485 Labeling Regulations. 820............................... Current Good 0910-0073 Manufacturing Practice (CGMP); Quality System (QS) Regulation. Recommendations for Clinical CLIA Waiver 0910-0598 Laboratory Improvement Amendments Applications. of 1988 (CLIA) Waiver Applications for Manufacturers of In Vitro Diagnostic Devices-- Guidance for Industry and Food and Drug Administration Staff. [[Page 61650]] Administrative Procedures for CLIA Administrative 0910-0607 Categorization--Guidance for Procedures for Industry and Food and Drug Clinical Laboratory Administration Staff. Improvement Amendments of 1988 Categorization (42 CFR 493.17). ------------------------------------------------------------------------ Dated: November 26, 2018. Leslie Kux, Associate Commissioner for Policy. [FR Doc. 2018-26034 Filed 11-29-18; 8:45 am] BILLING CODE 4164-01-P
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appropriate oversight of their clinical and biological products, medical recordkeeping provisions cover general
investigations to ensure adequate devices, and combinations thereof. The elements. The guidance discusses other
protection of the rights, welfare, and guidance describes strategies for elements sponsors and investigators
safety of human subjects and to ensure monitoring activities performed by should consider and include in
the quality and integrity of the resulting sponsors or by contract research developing a monitoring plan. As
data submitted to FDA. As part of this organizations (CROs) that focus on the explained in the guidance,
oversight, sponsors of clinical conduct, oversight, and reporting of documentation of monitoring should
investigations are required to monitor findings of an investigation by clinical include sufficient detail to allow
the conduct and progress of their investigators. The guidance also verification that the monitoring plan
clinical investigations. The regulations recommends strategies that reflect a
was followed. The plan should provide
do not specify how sponsors are to risk-based approach to monitoring that
adequate information to those involved
conduct monitoring of clinical focuses on critical study parameters and
investigations and are, therefore, relies on a combination of monitoring with monitoring to effectively carry out
compatible with a range of approaches activities to oversee a study effectively. their duties. All sponsor and CRO
to monitoring. Finally, the guidance specifically personnel who may be involved with
Accordingly, we developed the encourages greater reliance on monitoring (including those who review
guidance document entitled, ‘‘Guidance centralized monitoring methods where appropriate action, determine
for Industry—Oversight of Clinical appropriate. appropriate action, or both) regarding
Investigations: A Risk-Based Approach Information collections for reports potential issues identified through
to Monitoring.’’ The guidance is and records associated with clinical monitoring should review the
intended to assist sponsors of clinical investigations under parts 312 and 812 monitoring plan.
investigations in developing strategies are currently approved under OMB We estimate the burden of this
for risk-based monitoring and plans for control numbers 0910–0014 and 0910– collection of information as follows:
clinical investigations of human drug 0078 respectively. These reporting and
TABLE 1—ESTIMATED ANNUAL RECORDKEEPING BURDEN 1
Number of Average
Number of Total Annual
Activity records per burden per Total hours
recordkeepers Records
recordkeeper recordkeeping
Documentation included in comprehensive monitoring plan 88 1.5 132 4 528
1 There are no capital costs or operating and maintenance costs associated with this collection of information.
Based on a review of the information SUMMARY: The Food and Drug comment will be made public, you are
collection, we have made no Administration (FDA or Agency) is solely responsible for ensuring that your
adjustments to our burden estimate. We announcing the availability of the draft comment does not include any
estimate 88 sponsors will develop 132 guidance for industry and FDA staff confidential information that you or a
comprehensive monitoring plans in entitled ‘‘Blood Glucose Monitoring third party may not wish to be posted,
accordance with the guidance. We Test Systems for Prescription Point-of- such as medical information, your or
believe the associated burden for each Care Use.’’ This draft guidance anyone else’s Social Security number, or
plan is approximately 4 hours and document describes studies and criteria confidential business information, such
includes the time necessary to develop, that FDA recommends be used when as a manufacturing process. Please note
and amend as appropriate, the submitting premarket notifications that if you include your name, contact
monitoring plan. (510(k)s) for blood glucose monitoring information, or other information that
Dated: November 26, 2018. systems (BGMSs) that are for identifies you in the body of your
Leslie Kux,
prescription point-of-care use. This draft comments, that information will be
guidance is not final nor is it in effect posted on https://www.regulations.gov.
Associate Commissioner for Policy.
at this time. • If you want to submit a comment
[FR Doc. 2018–26032 Filed 11–29–18; 8:45 am]
DATES: Submit either electronic or with confidential information that you
BILLING CODE 4164–01–P
written comments on the draft guidance do not wish to be made available to the
by February 28, 2019 to ensure that the public, submit the comment as a
DEPARTMENT OF HEALTH AND Agency considers your comment on this written/paper submission and in the
HUMAN SERVICES draft guidance before it begins work on manner detailed (see ‘‘Written/Paper
the final version of the guidance. Submissions’’ and ‘‘Instructions’’).
Food and Drug Administration ADDRESSES: You may submit comments Written/Paper Submissions
on any guidance at any time as follows:
[Docket No. FDA–2013–D–1445] Submit written/paper submissions as
Electronic Submissions follows:
Blood Glucose Monitoring Test Submit electronic comments in the • Mail/Hand Delivery/Courier (for
Systems for Prescription Point-of-Care following way: written/paper submissions): Dockets
amozie on DSK3GDR082PROD with NOTICES1
Use; Draft Guidance for Industry and • Federal eRulemaking Portal: Management Staff (HFA–305), Food and
Food and Drug Administration Staff; https://www.regulations.gov. Follow the Drug Administration, 5630 Fishers
Availability instructions for submitting comments. Lane, Rm. 1061, Rockville, MD 20852.
AGENCY: Food and Drug Administration, Comments submitted electronically, • For written/paper comments
HHS. including attachments, to https:// submitted to the Dockets Management
www.regulations.gov will be posted to Staff, FDA will post your comment, as
ACTION: Notice of availability.
the docket unchanged. Because your well as any attachments, except for
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![61650 Federal Register / Vol. 83, No. 231 / Friday, November 30, 2018 / Notices
OMB Control
21 CFR part or guidance Topic No.
Administrative Procedures for CLIA Categorization—Guidance Administrative Procedures for Clinical Laboratory Improvement 0910–0607
for Industry and Food and Drug Administration Staff. Amendments of 1988 Categorization (42 CFR 493.17).
Dated: November 26, 2018. 11:59 p.m. Eastern Time at the end of Instructions: All submissions received
Leslie Kux, January 14, 2019. Comments received by must include the Docket No. FDA–
Associate Commissioner for Policy. mail/hand delivery/courier (for written/ 2018–N–4116 for ‘‘Bone, Reproductive
[FR Doc. 2018–26034 Filed 11–29–18; 8:45 am] paper submissions) will be considered and Urologic Drugs Advisory
BILLING CODE 4164–01–P
timely if they are postmarked or the Committee; Notice of Meeting;
delivery service acceptance receipt is on Establishment of a Public Docket;
or before that date. Request for Comments.’’ Received
DEPARTMENT OF HEALTH AND Comments received on or before comments, those filed in a timely
HUMAN SERVICES December 31, 2018, will be provided to manner (see ADDRESSES), will be placed
the committee. Comments received after in the docket and, except for those
Food and Drug Administration that date will be taken into submitted as ‘‘Confidential
[Docket No. FDA–2018–N–4116]
consideration by FDA. Submissions,’’ publicly viewable at
You may submit comments as https://www.regulations.gov or at the
Bone, Reproductive and Urologic follows: Dockets Management Staff between 9
Drugs Advisory Committee; Notice of Electronic Submissions a.m. and 4 p.m., Monday through
Meeting; Establishment of a Public Friday.
Submit electronic comments in the
Docket; Request for Comments • Confidential Submissions—To
following way:
submit a comment with confidential
AGENCY: Food and Drug Administration, • Federal eRulemaking Portal:
information that you do not wish to be
HHS. https://www.regulations.gov. Follow the
made publicly available, submit your
ACTION: Notice; establishment of a instructions for submitting comments.
comments only as a written/paper
public docket; request for comments. Comments submitted electronically,
submission. You should submit two
including attachments, to https://
copies total. One copy will include the
SUMMARY: The Food and Drug www.regulations.gov will be posted to
information you claim to be confidential
Administration (FDA) announces a the docket unchanged. Because your
with a heading or cover note that states
forthcoming public advisory committee comment will be made public, you are
‘‘THIS DOCUMENT CONTAINS
meeting of the Bone, Reproductive and solely responsible for ensuring that your
CONFIDENTIAL INFORMATION.’’ FDA
Urologic Drugs Advisory Committee. comment does not include any
will review this copy, including the
The general function of the committee is confidential information that you or a
claimed confidential information, in its
to provide advice and recommendations third party may not wish to be posted,
consideration of comments. The second
to FDA on regulatory issues. The such as medical information, your or
copy, which will have the claimed
meeting will be open to the public. FDA anyone else’s Social Security number, or
confidential information redacted/
is establishing a docket for public confidential business information, such
blacked out, will be available for public
comment on this document. as a manufacturing process. Please note
viewing and posted on https://
DATES: The meeting will be held on that if you include your name, contact
www.regulations.gov. Submit both
January 16, 2019, from 8:15 a.m. to 5 information, or other information that
copies to the Dockets Management Staff.
p.m. identifies you in the body of your
If you do not wish your name and
comments, that information will be
ADDRESSES: FDA White Oak Campus, contact information be made publicly
posted on https://www.regulations.gov.
10903 New Hampshire Ave., Bldg. 31 • If you want to submit a comment available, you can provide this
Conference Center, the Great Room (Rm. with confidential information that you information on the cover sheet and not
1503), Silver Spring, MD 20993–0002. do not wish to be made available to the in the body of your comments and you
Answers to commonly asked questions public, submit the comment as a must identify the information as
including information regarding special written/paper submission and in the ‘‘confidential.’’ Any information marked
accommodations due to a disability, manner detailed (see ‘‘Written/Paper as ‘‘confidential’’ will not be disclosed
visitor parking, and transportation may Submissions’’ and ‘‘Instructions’’). except in accordance with 21 CFR 10.20
be accessed at: https://www.fda.gov/ and other applicable disclosure law. For
AdvisoryCommittees/AboutAdvisory Written/Paper Submissions more information about FDA’s posting
Committees/ucm408555.htm. Submit written/paper submissions as of comments to public dockets, see 80
FDA is establishing a docket for follows: FR 56469, September 18, 2015, or access
public comment on this meeting. The • Mail/Hand delivery/Courier (for the information at: https://www.gpo.gov/
docket number is FDA–2018–N–4116. written/paper submissions): Dockets fdsys/pkg/FR-2015-09-18/pdf/2015-
The docket will close on January 14, Management Staff (HFA–305), Food and 23389.pdf.
2019. Submit either electronic or Drug Administration, 5630 Fishers Docket: For access to the docket to
written comments on this public Lane, Rm. 1061, Rockville, MD 20852. read background documents or the
amozie on DSK3GDR082PROD with NOTICES1
meeting by January 14, 2019. Please • For written/paper comments electronic and written/paper comments
note that late, untimely filed comments submitted to the Dockets Management received, go to https://
will not be considered. Electronic Staff, FDA will post your comment, as www.regulations.gov and insert the
comments must be submitted on or well as any attachments, except for docket number, found in brackets in the
before January 14, 2019. The https:// information submitted, marked and heading of this document, into the
www.regulations.gov electronic filing identified, as confidential, if submitted ‘‘Search’’ box and follow the prompts
system will accept comments until as detailed in ‘‘Instructions.’’ and/or go to the Dockets Management
VerDate Sep<11>2014 17:00 Nov 29, 2018 Jkt 247001 PO 00000 Frm 00052 Fmt 4703 Sfmt 4703 E:\FR\FM\30NON1.SGM 30NON1](https://thefederalregister.org/doc/83_FR_61879/page/3.svg)
Document Created: 2018-11-30 04:35:19
Document Modified: 2018-11-30 04:35:19
| Category | Regulatory Information | |
| Collection | Federal Register | |
| sudoc Class | AE 2.7: GS 4.107: AE 2.106: | |
| Publisher | Office of the Federal Register, National Archives and Records Administration | |
| Section | Notices | |
| Action | Notice of availability. | |
| Dates | Submit either electronic or written comments on the draft guidance by February 28, 2019 to ensure that the Agency considers your comment on this draft guidance before it begins work on the final version of the guidance. | |
| Contact | Leslie Landree, Center for Devices and Radiological Health, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 66, Rm. 4623, Silver Spring, MD 20993-0002, 301-796-6147. | |
| FR Citation | 83 FR 61648 |
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