Self-Monitoring Blood Glucose Test Systems for Over-the-Counter Use; Guidance for Industry and Food and Drug Administration Staff; Availability, 70120-70122 [2016-24431]

Download as PDF asabaliauskas on DSK3SPTVN1PROD with NOTICES 70120 Federal Register / Vol. 81, No. 196 / Tuesday, October 11, 2016 / Notices • 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– 2015–D–4012 for ‘‘Sunscreen Innovation Act; Withdrawal of a 586A Request or Pending Request.’’ 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. VerDate Sep<11>2014 20:12 Oct 07, 2016 Jkt 241001 Submit written requests for single copies of this guidance to the Division of Drug Information, Center for Drug Evaluation and Research, Food and Drug Administration, 10001 New Hampshire Ave., Hillandale Building, 4th Floor, Silver Spring, MD 20993– 0002. Send one self-addressed adhesive label to assist that office in processing your requests. See the SUPPLEMENTARY INFORMATION section for electronic access to the guidance document. FOR FURTHER INFORMATION CONTACT: Kristen Hardin, Center for Drug Evaluation and Research, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 22, Rm. 5443, Silver Spring, MD 20993, 240–402– 4246. SUPPLEMENTARY INFORMATION: I. Background FDA is announcing the availability of a guidance for industry entitled ‘‘Sunscreen Innovation Act; Withdrawal of a 586A Request or Pending Request.’’ This guidance provides background information on the sunscreen OTC monograph process and the new procedures under the SIA (21 U.S.C. 360fff), for reviewing 586A requests (requests made under section 586A of the FD&C Act (21 U.S.C. 360fff–1)) and pending requests for nonprescription sunscreen active ingredients (the SIA process). This guidance provides recommendations for the general withdrawal process for 586A requests and pending requests. At certain stages of the SIA process, a sponsor who submitted the 586A request or pending request might seek to have it withdrawn, or a request may be withdrawn due to the sponsor’s failure to act on the request and failure to respond to communications from FDA. This guidance addresses the expected effect of a withdrawal on key phases of the SIA process, including withdrawals made prior to or after the initial eligibility determination, the submission of safety and efficacy data, the filing determination, or the GRASE determination. This guidance also discusses the submission of a new 586A request for the same sunscreen ingredient for which a 586A or pending request had been previously submitted and withdrawn. This guidance finalizes the draft guidance that was issued under the same title on November 23, 2015 (see 80 FR 72970), and reflects FDA’s consideration of public comments on the draft guidance. The draft guidance and related public comments are publicly available in Docket No. FDA– 2015–D–4012. In addition to minor PO 00000 Frm 00036 Fmt 4703 Sfmt 4703 editorial changes, we have clarified the use of publicly available data and information submitted to the docket as it pertains to the withdrawal process. 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 the withdrawal of 586A requests and pending requests under the SIA. 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 with access to the Internet may obtain the guidance at either http:// www.fda.gov/Drugs/Guidance ComplianceRegulatoryInformation/ Guidances/default.htm or http:// www.regulations.gov. III. Paperwork Reduction Act of 1995 This guidance contains collections of information that are exempt from the Paperwork Reduction Act of 1995 (44 U.S.C. 3501–3520) (PRA). Section 586D(a)(1)(C) of the FD&C Act (21 U.S.C 360fff–4(a)(1)(C)) states that the PRA shall not apply to collections of information made for purposes of guidance under section 586D(a). Dated: October 5, 2016. Leslie Kux, Associate Commissioner for Policy. [FR Doc. 2016–24459 Filed 10–7–16; 8:45 am] BILLING CODE 4164–01–P 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. The Food and Drug Administration (FDA or Agency) is announcing the availability of the guidance entitled ‘‘Self-Monitoring Blood Glucose Test Systems for Overthe-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-thecounter (OTC) home use by lay-users. SUMMARY: E:\FR\FM\11OCN1.SGM 11OCN1 Federal Register / Vol. 81, No. 196 / Tuesday, October 11, 2016 / Notices 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’’). asabaliauskas on DSK3SPTVN1PROD with NOTICES 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-theCounter Use; Guidance for Industry and Food and Drug Administration Staff; Availability.’’ Received comments will VerDate Sep<11>2014 20:12 Oct 07, 2016 Jkt 241001 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 PO 00000 Frm 00037 Fmt 4703 Sfmt 4703 70121 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-ofcare 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 prescriptionuse 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 E:\FR\FM\11OCN1.SGM 11OCN1 70122 Federal Register / Vol. 81, No. 196 / Tuesday, October 11, 2016 / Notices 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 Overthe-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 Overthe-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. asabaliauskas on DSK3SPTVN1PROD with NOTICES 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 CDRHGuidance@fda.hhs.gov 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; VerDate Sep<11>2014 20:12 Oct 07, 2016 Jkt 241001 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 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. 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: SUMMARY: 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 PO 00000 Frm 00038 Fmt 4703 Sfmt 4703 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 E:\FR\FM\11OCN1.SGM 11OCN1

Agencies

[Federal Register Volume 81, Number 196 (Tuesday, October 11, 2016)]
[Notices]
[Pages 70120-70122]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[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 CDRH-Guidance@fda.hhs.gov 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