Food and Drug Administration, HHS.
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.
Submit either electronic or written comments on this guidance at any time. General comments on Agency guidance documents are welcome at any time.
You may submit comments as follows:
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”).
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 Start Printed Page 70123claimed 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.
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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.
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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 Start Printed Page 70124Use” may send an email request to CDRH-Guidance@fda.hhs.gov 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.
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Dated: October 4, 2016.
Associate Commissioner for Policy.
[FR Doc. 2016-24430 Filed 10-7-16; 8:45 am]
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