81 FR 70122 - Blood Glucose Monitoring Test Systems for Prescription Point-of-Care Use; 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 196 (October 11, 2016)
Food and Drug Administration
Federal Register Volume 81, Issue 196 (October 11, 2016)
| Page Range | 70122-70124 | |
| FR Document | 2016-24430 |
[Federal Register Volume 81, Number 196 (Tuesday, October 11, 2016)] [Notices] [Pages 70122-70124] From the Federal Register Online [www.thefederalregister.org] [FR Doc No: 2016-24430] ----------------------------------------------------------------------- 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; 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 guidance entitled ``Blood Glucose Monitoring Test Systems for Prescription Point-of-Care Use.'' This document describes studies and criteria that FDA recommends be used when submitting premarket notifications (510(k)s) for blood glucose monitoring systems (BGMSs) which are for prescription point-of-care use in professional healthcare settings. FDA intends for this document to serve as a guide for manufacturers in conducting appropriate performance studies and preparing 510(k)s for these device types. 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-2013-D-1445 for ``Blood Glucose Monitoring Test Systems for Prescription Point-of-Care Use; Guidance for Industry and Food and Drug Administration Staff; Availability.'' 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 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 [[Page 70123]] 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 copy of the guidance document 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, Bldg. 66, Rm. 4623, 10903 New Hampshire Ave., Silver Spring, MD 20993-0002, 301-796-6147. SUPPLEMENTARY INFORMATION: I. Background This document describes studies and criteria that FDA recommends be used when submitting 510(k)s for BGMSs which are for prescription point-of-care use in professional settings. FDA intends for this document to serve as a guide for manufacturers in conducting appropriate performance studies and preparing 510(k)s for these device types. This document is not meant to address self-monitoring blood glucose test systems (SMBGs) for over-the-counter (OTC) home use by lay-users. Elsewhere in this issue of the Federal Register, FDA is announcing the availability of the guidance ``Self-Monitoring Blood Glucose Test Systems for Over-the-Counter Use'' to address those device types. Historically, FDA has not recommended different types of information in 510(k)s for BGMSs used by healthcare professionals as compared to SMBGs intended for home use by lay-users. However, it has become increasingly clear that these different use settings have distinct intended use populations with unique characteristics that can impact device design specifications, and that manufacturers should take these unique characteristics into account when designing their devices. In order to distinguish between FDA recommendations for prescription- use blood glucose meters, which are intended for use in point-of-care professional healthcare settings, and SMBG devices intended for home use for self-monitoring by lay-persons, the Agency is issuing two separate guidances for (i) BGMSs intended for use in point-of-care professional healthcare settings, and (ii) SMBGs intended for home use for self-monitoring by lay-users. FDA believes that in making this distinction, BGMSs can be better designed to meet the needs of their intended use populations, thereby providing greater safety and efficacy. Because BGMSs are used in professional healthcare settings, they are more likely to be used on multiple patients. The Centers for Medicare and Medicaid Services and Centers for Disease Control and Prevention have expressed concern over the possibility that blood glucose meters can transmit bloodborne pathogens if these devices are contaminated with blood specimens and shared between users without effective cleaning, disinfecting, and appropriate infection control measures. This document describes certain design features and capacity for cleaning and disinfection to prevent the spread of bloodborne pathogens. In addition, concerns have been raised citing the inability of currently cleared BGMSs to perform effectively in professional healthcare settings because these devices have not been adequately evaluated in some of the populations in which they are being used. Patients in professional healthcare settings are often fundamentally different than lay-users using these devices at home. Patients in professional healthcare settings can be acutely ill and medically fragile and are more likely to present physiological and pathological factors that could interfere with glucose measurements relative to lay- users. Errors in BGMSs accuracy can lead to incorrect insulin dosing, which, when combined with other factors, can lead to increased episodes of hypoglycemia. For hospitalized patients who may be seriously ill, glucose meter inaccuracies could further increase risk to health. This document describes studies that can be conducted to demonstrate BGMS performance for devices intended to be used in diverse professional healthcare settings on subjects in various states of health. While FDA recommends that the information described in this guidance be included in premarket submissions for BGMSs, submissions containing alternative information may be sufficient if able to demonstrate substantial equivalence to a legally marketed predicate device. In the Federal Register of January 7, 2014 (79 FR 830), the Agency issued the draft guidance entitled ``Blood Glucose Monitoring Test Systems for Prescription Point-of-Care Use''. In the Federal Register of April 9, 2014 (79 FR 19622), the Agency announced that the deadline for the comment period would be extended until May 7, 2014, to allow for more public comments on this draft guidance document. FDA considered the comments received on this draft guidance and FDA revised the guidance as appropriate in response to the comments. 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 ``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. 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.regulations.gov. Persons unable to download an electronic copy of ``Blood Glucose Monitoring Test Systems for Prescription Point-of-Care [[Page 70124]] Use'' may send an email request to [email protected] to receive an electronic copy of the document. Please use the document number 1755 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 and guidance. 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 801 and 21 CFR 809.10 have been approved under OMB control number 0910-0485; the collections of information in 21 CFR part 820 have been approved under OMB control number 0910-0073; the collections of information in the guidance document ``Recommendations: Clinical Laboratory Improvement Amendments of 1988 (CLIA) Waiver Applications for Manufacturers of In Vitro Diagnostic Devices'' have been approved under OMB control number 0910-0598; 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: October 4, 2016. Leslie Kux, Associate Commissioner for Policy. [FR Doc. 2016-24430 Filed 10-7-16; 8:45 am] BILLING CODE 4164-01-P
![70122 Federal Register / Vol. 81, No. 196 / Tuesday, October 11, 2016 / Notices
substantial equivalence to a legally the collections of information in 21 CFR the docket unchanged. Because your
marketed predicate device. part 820 have been approved under comment will be made public, you are
In the Federal Register of January 7, OMB control number 0910–0073; and solely responsible for ensuring that your
2014 (79 FR 829), the Agency issued the the collections of information in the comment does not include any
draft guidance entitled ‘‘Self-Monitoring guidance document ‘‘Requests for confidential information that you or a
Blood Glucose Test Systems for Over- Feedback on Medical Device third party may not wish to be posted,
the-Counter Use.’’ In the Federal Submissions: The Pre-Submission such as medical information, your or
Register of April 9, 2014 (79 FR 19622), Program and Meetings with Food and anyone else’s Social Security number, or
the Agency announced that the deadline Drug Administration Staff’’ have been confidential business information, such
for the comment period would be approved under OMB control number as a manufacturing process. Please note
extended until May 7, 2014, to allow for 0910–0756. that if you include your name, contact
more public comments on this draft information, or other information that
Dated: October 4, 2016.
guidance document. FDA considered identifies you in the body of your
the comments received on this draft Leslie Kux,
comments, that information will be
guidance and FDA revised the guidance Associate Commissioner for Policy. posted on http://www.regulations.gov.
as appropriate in response to the [FR Doc. 2016–24431 Filed 10–7–16; 8:45 am] • If you want to submit a comment
comments. BILLING CODE 4164–01–P with confidential information that you
do not wish to be made available to the
II. Significance of Guidance
public submit, the comment as a
This guidance is being issued DEPARTMENT OF HEALTH AND written/paper submission and in the
consistent with FDA’s good guidance HUMAN SERVICES manner detailed (see ‘‘Written/Paper
practices regulation (21 CFR 10.115). Submissions’’ and ‘‘Instructions’’).
The guidance represents the current Food and Drug Administration
thinking of FDA on ‘‘Self-Monitoring Written/Paper Submissions
[Docket No. FDA–2013–D–1445]
Blood Glucose Test Systems for Over- Submit written/paper submissions as
the-Counter Use.’’ It does not establish Blood Glucose Monitoring Test follows:
any rights for any person and is not Systems for Prescription Point-of-Care • Mail/Hand delivery/Courier (for
binding on FDA or the public. You can Use; Guidance for Industry and Food written/paper submissions): Division of
use an alternative approach if it satisfies and Drug Administration Staff; Dockets Management (HFA–305), Food
the requirements of the applicable Availability and Drug Administration, 5630 Fishers
statutes and regulations. Lane, Rm. 1061, Rockville, MD 20852.
AGENCY: Food and Drug Administration, • For written/paper comments
III. Electronic Access HHS. submitted to the Division of Dockets
Persons interested in obtaining a copy ACTION: Notice of availability. Management, FDA will post your
of the guidance may do so by comment, as well as any attachments,
downloading an electronic copy from SUMMARY: The Food and Drug except for information submitted,
the Internet. A search capability for all Administration (FDA or Agency) is marked and identified, as confidential,
Center for Devices and Radiological announcing the availability of the if submitted as detailed in
Health guidance documents is available guidance entitled ‘‘Blood Glucose ‘‘Instructions.’’
at http://www.fda.gov/MedicalDevices/ Monitoring Test Systems for Instructions: All submissions received
DeviceRegulationandGuidance/ Prescription Point-of-Care Use.’’ This must include the Docket No. FDA–
GuidanceDocuments/default.htm. document describes studies and criteria 2013–D–1445 for ‘‘Blood Glucose
Guidance documents are also available that FDA recommends be used when Monitoring Test Systems for
at http://www.regulations.gov. Persons submitting premarket notifications Prescription Point-of-Care Use;
unable to download an electronic copy (510(k)s) for blood glucose monitoring Guidance for Industry and Food and
of ‘‘Self-Monitoring Blood Glucose Test systems (BGMSs) which are for Drug Administration Staff;
Systems for Over-the-Counter Use’’ may prescription point-of-care use in Availability.’’ Received comments will
send an email request to CDRH- professional healthcare settings. FDA be placed in the docket and, except for
Guidance@fda.hhs.gov to receive an intends for this document to serve as a those submitted as ‘‘Confidential
electronic copy of the document. Please guide for manufacturers in conducting Submissions,’’ publicly viewable at
use the document number 1756 to appropriate performance studies and http://www.regulations.gov or at the
identify the guidance you are preparing 510(k)s for these device types. Division of Dockets Management
requesting. DATES: Submit either electronic or between 9 a.m. and 4 p.m., Monday
written comments on this guidance at through Friday.
IV. Paperwork Reduction Act of 1995 any time. General comments on Agency • Confidential Submissions—To
This guidance refers to previously guidance documents are welcome at any submit a comment with confidential
approved collections of information time. information that you do not wish to be
found in FDA regulations and guidance. ADDRESSES: You may submit comments made publicly available submit your
These collections of information are as follows: comments only as a written/paper
subject to review by the Office of submission. You should submit two
Management and Budget (OMB) under Electronic Submissions copies total. One copy will include the
asabaliauskas on DSK3SPTVN1PROD with NOTICES
the Paperwork Reduction Act of 1995 Submit electronic comments in the information you claim to be confidential
(44 U.S.C. 3501–3520). The collections following way: with a heading or cover note that states
of information in 21 CFR part 807 • Federal eRulemaking Portal: http:// ‘‘THIS DOCUMENT CONTAINS
subpart E have been approved under www.regulations.gov. Follow the CONFIDENTIAL INFORMATION.’’ The
OMB control number 0910–0120; the instructions for submitting comments. Agency will review this copy, including
collections of information in 21 CFR 801 Comments submitted electronically, the claimed confidential information, in
and 21 CFR 809.10 have been approved including attachments, to http:// its consideration of comments. The
under OMB control number 0910–0485; www.regulations.gov will be posted to second copy, which will have the
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![70124 Federal Register / Vol. 81, No. 196 / Tuesday, October 11, 2016 / Notices
Use’’ may send an email request to to the public and will be accessible by is full, individuals who could not be
CDRH-Guidance@fda.hhs.gov to receive webcast and conference call. accommodated are welcome to provide
an electronic copy of the document. Name of Committee: Interagency Autism written comments instead. Comments to
Please use the document number 1755 Coordinating Committee (IACC). be read or presented in the meeting
to identify the guidance you are Type of meeting: Open Meeting. must not exceed 250 words or 3
requesting. Date: October 26, 2016. minutes, but a longer version may be
Time: 9:00 a.m. to 5:00 p.m.* Eastern Time submitted in writing for the record.
IV. Paperwork Reduction Act of 1995 * Approximate end time. Commenters going beyond the 250 word
This guidance refers to previously Agenda: To discuss business, updates, and or 3 minute time limit in the meeting
issues related to ASD research and services may be asked to conclude immediately
approved collections of information activities. The Committee will discuss
found in FDA regulations and guidance. updates of the IACC Strategic Plan.
in order to allow other comments and
These collections of information are Place: National Institutes of Health , 31 presentations to proceed on schedule.
subject to review by the Office of Center Drive, Building 31, C Wing, 6th Floor, Any interested person may submit
Management and Budget (OMB) under Conference Room 6, Bethesda, MD 20892. written public comments to the IACC
the Paperwork Reduction Act of 1995 Webcast Live: https://videocast.nih.gov. prior to the meeting by emailing the
(44 U.S.C. 3501–3520). The collections Conference Call Access: Dial: 888–469– comments to IACCPublicInquiries@
of information in 21 CFR part 807 2037, Access code: 3353029. mail.nih.gov or by submitting comments
subpart E have been approved under Cost: The meeting is free and open to the at the web link: https://iacc.hhs.gov/
public.
OMB control number 0910–0120; the Registration: A registration web link will
meetings/public-comments/submit/
collections of information in 21 CFR 801 be posted on the IACC Web site index.jsp by 5:00 p.m. ET on Tuesday,
and 21 CFR 809.10 have been approved (www.iacc.hhs.gov) prior to the meeting. Pre- October 18, 2016. The comments should
under OMB control number 0910–0485; registration is recommended to expedite include the name, address, telephone
the collections of information in 21 CFR check-in. Seating in the meeting room is number, and when applicable, the
part 820 have been approved under limited to room capacity and on a first come, business or professional affiliation of
OMB control number 0910–0073; the first served basis. Onsite registration will also the interested person. NIMH anticipates
collections of information in the be available. written public comments received by
guidance document ‘‘Recommendations: Deadlines: Notification of intent to present 5:00 p.m. ET on Tuesday, October 18,
oral comments: Wednesday, October 12,
Clinical Laboratory Improvement 2016 by 5:00 p.m. ET.
2016 will be presented to the Committee
Amendments of 1988 (CLIA) Waiver Submission of written/electronic statement prior to the meeting for the Committee’s
Applications for Manufacturers of In for oral comments: Tuesday, October 18, consideration. Any written comments
Vitro Diagnostic Devices’’ have been 2016 by 5:00 p.m. ET. received after the 5:00 p.m. ET, October
approved under OMB control number Submission of written comments: Tuesday, 18, 2016 deadline through October 25,
0910–0598; and the collections of October 18, 2016 by 5:00 p.m. ET. 2016 will be provided to the Committee
information in the guidance document For IACC Public Comment guidelines either before or after the meeting,
‘‘Requests for Feedback on Medical please see: https://iacc.hhs.gov/meetings/ depending on the volume of comments
Device Submissions: The Pre- public-comments/guidelines/. received and the time required to
Access: Medical Center Metro Station (Red
Submission Program and Meetings with Line).
process them in accordance with
Food and Drug Administration Staff’’ Contact Person: Ms. Angelice Mitrakas, privacy regulations and other applicable
have been approved under OMB control Office of Autism Research Coordination, Federal policies. All written public
number 0910–0756. National Institute of Mental Health, NIH, comments and oral public comment
Dated: October 4, 2016. 6001 Executive Boulevard, Room 6182A, statements received by the deadlines for
Bethesda, MD 20892–9669, Phone: 301–435– both oral and written public comments
Leslie Kux,
9269, Email: IACCPublicInquiries@ will be provided to the IACC for their
Associate Commissioner for Policy. mail.nih.gov. consideration and will become part of
[FR Doc. 2016–24430 Filed 10–7–16; 8:45 am]
Public Comments: Any member of the the public record. Attachments of
BILLING CODE 4164–01–P
public interested in presenting oral copyrighted publications are not
comments to the Committee must notify permitted, but web links or citations for
the Contact Person listed on this notice any copyrighted works cited may be
DEPARTMENT OF HEALTH AND
by 5:00 p.m. ET on Wednesday, October provided.
HUMAN SERVICES
12, 2016, with their request to present In the 2009 IACC Strategic Plan, the
National Institutes of Health oral comments at the meeting, and a IACC listed the ‘‘Spirit of Collaboration’’
written/electronic copy of the oral as one of its core values, stating that,
National Institute of Mental Health presentation/statement must be ‘‘We will treat others with respect, listen
(NIMH); Notice of Meeting submitted by 5:00 p.m. ET on Tuesday, to diverse views with open minds,
October 18, discuss submitted public comments,
Pursuant to section 10(a) of the A limited number of slots for oral and foster discussions where
Federal Advisory Committee Act, as comment are available, and in order to participants can comfortably offer
amended (5 U.S.C. App.), notice is ensure that as many different opposing opinions.’’ In keeping with
hereby given of an Interagency Autism individuals are able to present this core value, the IACC and the NIMH
Coordinating Committee (IACC or throughout the year as possible, any Office of Autism Research Coordination
asabaliauskas on DSK3SPTVN1PROD with NOTICES
Committee) meeting. given individual only will be permitted (OARC) ask that members of the public
The purpose of the IACC meeting is to present oral comments once per who provide public comments or
to discuss business, agency updates, and calendar year (2016). Only one participate in meetings of the IACC also
issues related to autism spectrum representative of an organization will be seek to treat others with respect and
disorder (ASD) research and services allowed to present oral comments in consideration in their communications
activities. The Committee will discuss any given meeting; other representatives and actions, even when discussing
the 2016–2017 update of the IACC of the same group may provide written issues of genuine concern or
Strategic Plan. The meeting will be open comments. If the oral comment session disagreement.
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Document Created: 2018-02-13 16:33:42
Document Modified: 2018-02-13 16:33:42
| 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 this guidance at any time. General comments on Agency guidance documents are welcome at any time. | |
| Contact | Leslie Landree, Center for Devices and Radiological Health, Food and Drug Administration, Bldg. 66, Rm. 4623, 10903 New Hampshire Ave., Silver Spring, MD 20993-0002, 301-796-6147. | |
| FR Citation | 81 FR 70122 |
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