81 FR 70120 - Self-Monitoring Blood Glucose Test Systems for Over-the-Counter 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 | 70120-70122 | |
| FR Document | 2016-24431 |
[Federal Register Volume 81, Number 196 (Tuesday, October 11, 2016)] [Notices] [Pages 70120-70122] From the Federal Register Online [www.thefederalregister.org] [FR Doc No: 2016-24431] ----------------------------------------------------------------------- DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2013-D-1446] Self-Monitoring Blood Glucose Test Systems for Over-the-Counter 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 ``Self-Monitoring Blood Glucose Test Systems for Over-the-Counter Use.'' This document describes studies and criteria that FDA recommends be used when submitting premarket notifications (510(k)s) for self-monitoring blood glucose test systems (SMBGs) intended for over-the-counter (OTC) home use by lay-users. [[Page 70121]] 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-1446 for ``Self-Monitoring Blood Glucose Test Systems for Over-the-Counter 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 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 single copies of the guidance 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 This document describes studies and criteria that FDA recommends be used when submitting 510(k)s for SMBGs which are for OTC home use by lay users. 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 blood glucose monitoring test systems (BGMSs) which are intended for prescription point-of-care use in professional healthcare settings (e.g., hospitals, physician offices, long term care facilities, etc.). Elsewhere in this issue of the Federal Register, FDA is announcing the availability of the guidance ``Blood Glucose Monitoring Test Systems for Prescription Point-of-Care 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 BGMSs, which are intended for use in point-of-care professional healthcare settings, and SMBGs intended for use for self-monitoring by lay users, the Agency is issuing two separate guidances for: (1) Prescription use blood glucose meters, for use in point-of-care professional healthcare settings and (2) OTC SMBG devices intended for home use for self-monitoring by lay persons. FDA believes that in making this distinction, SMBGs can be better designed to meet the needs of their intended use populations, thereby providing greater safety and efficacy. While FDA recommends that the information described in this guidance be included in premarket submissions for SMBGs, submissions containing alternative information may be sufficient if able to demonstrate [[Page 70122]] substantial equivalence to a legally marketed predicate device. In the Federal Register of January 7, 2014 (79 FR 829), the Agency issued the draft guidance entitled ``Self-Monitoring Blood Glucose Test Systems for Over-the-Counter 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 ``Self-Monitoring Blood Glucose Test Systems for Over-the-Counter 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 ``Self-Monitoring Blood Glucose Test Systems for Over-the-Counter Use'' may send an email request to [email protected] to receive an electronic copy of the document. Please use the document number 1756 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; 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. 2016-24431 Filed 10-7-16; 8:45 am] BILLING CODE 4164-01-P
![70120 Federal Register / Vol. 81, No. 196 / Tuesday, October 11, 2016 / Notices
• For written/paper comments Submit written requests for single editorial changes, we have clarified the
submitted to the Division of Dockets copies of this guidance to the Division use of publicly available data and
Management, FDA will post your of Drug Information, Center for Drug information submitted to the docket as
comment, as well as any attachments, Evaluation and Research, Food and it pertains to the withdrawal process.
except for information submitted, Drug Administration, 10001 New This guidance is being issued
marked and identified, as confidential, Hampshire Ave., Hillandale Building, consistent with FDA’s good guidance
if submitted as detailed in 4th Floor, Silver Spring, MD 20993– practices regulation (21 CFR 10.115).
‘‘Instructions.’’ 0002. Send one self-addressed adhesive The guidance represents the current
Instructions: All submissions received label to assist that office in processing thinking of FDA on the withdrawal of
must include the Docket No. FDA– your requests. See the SUPPLEMENTARY 586A requests and pending requests
2015–D–4012 for ‘‘Sunscreen INFORMATION section for electronic under the SIA. It does not establish any
Innovation Act; Withdrawal of a 586A access to the guidance document. rights for any person and is not binding
Request or Pending Request.’’ Received FOR FURTHER INFORMATION CONTACT: on FDA or the public. You can use an
comments will be placed in the docket Kristen Hardin, Center for Drug alternative approach if it satisfies the
and, except for those submitted as Evaluation and Research, Food and requirements of the applicable statutes
‘‘Confidential Submissions,’’ publicly Drug Administration, 10903 New and regulations.
viewable at http://www.regulations.gov Hampshire Ave., Bldg. 22, Rm. 5443, II. Electronic Access
or at the Division of Dockets Silver Spring, MD 20993, 240–402–
Management between 9 a.m. and 4 p.m., 4246. Persons with access to the Internet
Monday through Friday. may obtain the guidance at either http://
SUPPLEMENTARY INFORMATION: www.fda.gov/Drugs/Guidance
• Confidential Submissions—To
submit a comment with confidential I. Background ComplianceRegulatoryInformation/
information that you do not wish to be Guidances/default.htm or http://
FDA is announcing the availability of www.regulations.gov.
made publicly available, submit your a guidance for industry entitled
comments only as a written/paper ‘‘Sunscreen Innovation Act; Withdrawal III. Paperwork Reduction Act of 1995
submission. You should submit two of a 586A Request or Pending Request.’’ This guidance contains collections of
copies total. One copy will include the This guidance provides background information that are exempt from the
information you claim to be confidential information on the sunscreen OTC Paperwork Reduction Act of 1995 (44
with a heading or cover note that states monograph process and the new U.S.C. 3501–3520) (PRA). Section
‘‘THIS DOCUMENT CONTAINS procedures under the SIA (21 U.S.C. 586D(a)(1)(C) of the FD&C Act (21 U.S.C
CONFIDENTIAL INFORMATION.’’ The 360fff), for reviewing 586A requests 360fff–4(a)(1)(C)) states that the PRA
Agency will review this copy, including (requests made under section 586A of shall not apply to collections of
the claimed confidential information, in the FD&C Act (21 U.S.C. 360fff–1)) and information made for purposes of
its consideration of comments. The pending requests for nonprescription guidance under section 586D(a).
second copy, which will have the sunscreen active ingredients (the SIA
claimed confidential information Dated: October 5, 2016.
process). This guidance provides
redacted/blacked out, will be available Leslie Kux,
recommendations for the general
for public viewing and posted on http:// withdrawal process for 586A requests Associate Commissioner for Policy.
www.regulations.gov. Submit both and pending requests. At certain stages [FR Doc. 2016–24459 Filed 10–7–16; 8:45 am]
copies to the Division of Dockets of the SIA process, a sponsor who BILLING CODE 4164–01–P
Management. If you do not wish your submitted the 586A request or pending
name and contact information to be request might seek to have it
made publicly available, you can withdrawn, or a request may be DEPARTMENT OF HEALTH AND
provide this information on the cover withdrawn due to the sponsor’s failure HUMAN SERVICES
sheet and not in the body of your to act on the request and failure to
comments and you must identify this Food and Drug Administration
respond to communications from FDA.
information as ‘‘confidential.’’ Any This guidance addresses the expected [Docket No. FDA–2013–D–1446]
information marked as ‘‘confidential’’ effect of a withdrawal on key phases of
will not be disclosed except in the SIA process, including withdrawals Self-Monitoring Blood Glucose Test
accordance with 21 CFR 10.20 and other made prior to or after the initial Systems for Over-the-Counter Use;
applicable disclosure law. For more eligibility determination, the Guidance for Industry and Food and
information about FDA’s posting of submission of safety and efficacy data, Drug Administration Staff; Availability
comments to public dockets, see 80 FR the filing determination, or the GRASE AGENCY: Food and Drug Administration,
56469, September 18, 2015, or access determination. This guidance also HHS.
the information at: http://www.fda.gov/ discusses the submission of a new 586A ACTION: Notice of availability.
regulatoryinformation/dockets/ request for the same sunscreen
default.htm. ingredient for which a 586A or pending SUMMARY: The Food and Drug
Docket: For access to the docket to request had been previously submitted Administration (FDA or Agency) is
read background documents or the and withdrawn. announcing the availability of the
electronic and written/paper comments This guidance finalizes the draft guidance entitled ‘‘Self-Monitoring
asabaliauskas on DSK3SPTVN1PROD with NOTICES
received, go to http:// guidance that was issued under the Blood Glucose Test Systems for Over-
www.regulations.gov and insert the same title on November 23, 2015 (see 80 the-Counter Use.’’ This document
docket number, found in brackets in the FR 72970), and reflects FDA’s describes studies and criteria that FDA
heading of this document, into the consideration of public comments on recommends be used when submitting
‘‘Search’’ box and follow the prompts the draft guidance. The draft guidance premarket notifications (510(k)s) for
and/or go to the Division of Dockets and related public comments are self-monitoring blood glucose test
Management, 5630 Fishers Lane, Rm. publicly available in Docket No. FDA– systems (SMBGs) intended for over-the-
1061, Rockville, MD 20852. 2015–D–4012. In addition to minor counter (OTC) home use by lay-users.
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![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
VerDate Sep<11>2014 20:12 Oct 07, 2016 Jkt 241001 PO 00000 Frm 00038 Fmt 4703 Sfmt 4703 E:\FR\FM\11OCN1.SGM 11OCN1](https://thefederalregister.org/doc/81_FR_70316/page/3.svg)
Document Created: 2018-02-13 16:33:49
Document Modified: 2018-02-13 16:33:49
| 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, 10903 New Hampshire Ave., Bldg. 66, Rm. 4623, Silver Spring, MD 20993-0002, 301-796-6147. | |
| FR Citation | 81 FR 70120 |
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