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<p class="MsoNormal"><span style="font-size:14.0pt">I got the following email. <o:p>
</o:p></span></p>
<p class="MsoNormal"><span style="font-size:14.0pt">As many people suffer from diabetes and are going blind, we need to take steps to comment about the testing systems.
<o:p></o:p></span></p>
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<p class="MsoNormal"><b><span style="color:#1F497D">Yasmin Reyazuddin, Customer Service Representative II<o:p></o:p></span></b></p>
<p class="MsoNormal"><b><span style="color:#1F497D">MC311 Customer Service Center<o:p></o:p></span></b></p>
<p class="MsoNormal"><b><span style="color:#1F497D">Office of Public Information <o:p>
</o:p></span></b></p>
<p class="MsoNormal"><b><span style="color:#1F497D">1401 Rockville Pike., Suite #300<o:p></o:p></span></b></p>
<p class="MsoNormal"><b><span style="color:#1F497D">Rockville, MD 20852<o:p></o:p></span></b></p>
<p class="MsoNormal"><b><span style="color:#1F497D">phone: 240-777-0311<o:p></o:p></span></b></p>
<p class="MsoNormal"><b><span style="color:#1F497D">email: yasmin.reyazuddin<a href="mailto:your%20name@montgomerycountymd.gov"><span style="color:#1F497D;text-decoration:none">@montgomerycountymd.gov</span></a><o:p></o:p></span></b></p>
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<p class="MsoNormal"><b>From:</b> U.S. Food and Drug Administration [mailto:fda@info.fda.gov]
<br>
<b>Sent:</b> Thursday, November 29, 2018 9:30 AM<br>
<b>To:</b> Reyazuddin, Yasmin <Yasmin.Reyazuddin@montgomerycountymd.gov><br>
<b>Subject:</b> FDA Stakeholder Update - FDA Takes Steps to Advance the Safety and Accuracy of Blood Glucose Monitoring Test Systems<o:p></o:p></p>
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<p class="MsoNormal" align="center" style="text-align:center"><span style="font-size:7.5pt;font-family:"Arial",sans-serif">If your email program has trouble displaying this email, <a href="https://na01.safelinks.protection.outlook.com/?url=http%3A%2F%2Fapp.info.fda.gov%2Fe%2Fes%3Fs%3D2027422842%26e%3D167146%26elqTrackId%3D78D8A052C380BCBFF284D754BEBE9730%26elq%3Dd0742e119fbd4f37ad5191def1e5e9ee%26elqaid%3D6072%26elqat%3D1&data=01%7C01%7Cyasmin.reyazuddin%40montgomerycountymd.gov%7C3a804bc851974a0161c308d656072eb6%7C6e01b1f9b1e54073ac97778069a0ad64%7C1&sdata=PFZDFa9GhuYpa1%2B%2B74OLZvWl%2FGl99kqWMMRsX6VaudM%3D&reserved=0">view
it as a web page</a>. </span><o:p></o:p></p>
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<p class="MsoNormal" align="center" style="text-align:center"><img border="0" id="_x0000_i1025" src="http://Images.fda.gov/EloquaImages/clients/USDepartmentofHealthandHumanServicesFood/%7B978d2a57-b75d-4765-8032-6cce5cd09bae%7D_USFDA-Header-FINAL.png" alt="U.S. Food and Drug Administration Header"><o:p></o:p></p>
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<p class="MsoNormal" align="center" style="text-align:center"><i><span style="font-size:9.0pt;font-family:"Arial",sans-serif">FDA Stakeholder Update - Informing FDA stakeholders on key priorities that advance FDA’s public health mission.
</span></i><o:p></o:p></p>
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<p class="MsoNormal" align="right" style="text-align:right"><span style="font-size:8.5pt;font-family:"Arial",sans-serif;color:#7D7B7D">November 29, 2018</span><span style="font-size:8.5pt;font-family:"Arial",sans-serif">
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<p class="MsoNormal"><span style="font-size:10.5pt;font-family:"Arial",sans-serif">FDA announced the availability of the following two updated draft guidances that are intended to improve the accuracy, reliability, and safe use of blood glucose monitoring test
systems: <br>
<br>
<a href="https://na01.safelinks.protection.outlook.com/?url=https%3A%2F%2Fwww.fda.gov%2Fdownloads%2FMedicalDevices%2FDeviceRegulationandGuidance%2FGuidanceDocuments%2FUCM626743.pdf%3Futm_campaign%3DFDA%2520SEAT%2520Diabetes%2520Update%252011-28-18%26utm_medium%3Demail%26utm_source%3DEloqua%26elqTrackId%3Da215b1d6365440e0945ea69b97180271%26elq%3Dd0742e119fbd4f37ad5191def1e5e9ee%26elqaid%3D6072%26elqat%3D1%26elqCampaignId%3D4936&data=01%7C01%7Cyasmin.reyazuddin%40montgomerycountymd.gov%7C3a804bc851974a0161c308d656072eb6%7C6e01b1f9b1e54073ac97778069a0ad64%7C1&sdata=HaD6c0szaBRKSOh982wlu7XWTkU81eCWb%2BYMq0DpkLQ%3D&reserved=0"><strong><span style="font-family:"Arial",sans-serif">Blood
Glucose Monitoring Test Systems for Prescription Point-of-Care Use</span></strong></a><br>
This draft guidance document provides recommendations to industry about the types of information to include in their
<a href="https://na01.safelinks.protection.outlook.com/?url=https%3A%2F%2Fwww.fda.gov%2FAboutFDA%2FCentersOffices%2FOfficeofMedicalProductsandTobacco%2FCDRH%2FCDRHTransparency%2Fucm199907.htm%3Futm_campaign%3DFDA%2520SEAT%2520Diabetes%2520Update%252011-28-18%26utm_medium%3Demail%26utm_source%3DEloqua%26elqTrackId%3D53c34021d2a4416c9fddc69ca1ee96b4%26elq%3Dd0742e119fbd4f37ad5191def1e5e9ee%26elqaid%3D6072%26elqat%3D1%26elqCampaignId%3D4936&data=01%7C01%7Cyasmin.reyazuddin%40montgomerycountymd.gov%7C3a804bc851974a0161c308d656072eb6%7C6e01b1f9b1e54073ac97778069a0ad64%7C1&sdata=hV65L2xzJGO0xd451e283Q6%2FihRkbWmbLQ9xVsyGel8%3D&reserved=0">
premarket submissions</a> for blood glucose monitoring systems used for diabetes management in the health care setting.<br>
<br>
<a href="https://na01.safelinks.protection.outlook.com/?url=https%3A%2F%2Fwww.fda.gov%2Fdownloads%2FMedicalDevices%2FDeviceRegulationandGuidance%2FGuidanceDocuments%2FUCM626742.pdf%3Futm_campaign%3DFDA%2520SEAT%2520Diabetes%2520Update%252011-28-18%26utm_medium%3Demail%26utm_source%3DEloqua%26elqTrackId%3D73d3f9448de64cf5b722e815e07e197d%26elq%3Dd0742e119fbd4f37ad5191def1e5e9ee%26elqaid%3D6072%26elqat%3D1%26elqCampaignId%3D4936&data=01%7C01%7Cyasmin.reyazuddin%40montgomerycountymd.gov%7C3a804bc851974a0161c308d656072eb6%7C6e01b1f9b1e54073ac97778069a0ad64%7C1&sdata=6AyJmWs4ZIwcrS5jFDKxQtKiODn%2F7DHMOEfkS1jbdR8%3D&reserved=0"><strong><span style="font-family:"Arial",sans-serif">Self-Monitoring
Blood Glucose Test Systems for Over-the-Counter Use</span></strong></a><br>
This draft guidance document provides recommendations to industry about the studies and criteria to include in their premarket submissions for self-monitoring
<a href="https://na01.safelinks.protection.outlook.com/?url=https%3A%2F%2Fwww.fda.gov%2Fmedicaldevices%2Fproductsandmedicalprocedures%2Finvitrodiagnostics%2Fglucosetestingdevices%2Fdefault.htm%3Futm_campaign%3DFDA%2520SEAT%2520Diabetes%2520Update%252011-28-18%26utm_medium%3Demail%26utm_source%3DEloqua%26elqTrackId%3Db98ab8f7bb174b57b5fe74119759f696%26elq%3Dd0742e119fbd4f37ad5191def1e5e9ee%26elqaid%3D6072%26elqat%3D1%26elqCampaignId%3D4936&data=01%7C01%7Cyasmin.reyazuddin%40montgomerycountymd.gov%7C3a804bc851974a0161c308d656072eb6%7C6e01b1f9b1e54073ac97778069a0ad64%7C1&sdata=xxDoqNY2KuJCdB7V3iz9dTtXJOpnKt%2BUKmwBKpgL%2BYs%3D&reserved=0">
blood glucose test systems</a> used for diabetes management in the home setting.<br>
<br>
Following publication of final guidances in October 2016, the FDA received feedback from medical device developers and manufacturers requesting more clarification on design considerations and recommended standards that may improve the usability of the guidances.
The FDA is publishing these draft guidances today to allow our customers in industry, health care, and the patient community to review and provide comments on the clarifications made to the testing methods and labeling sections.<br>
<br>
The updates were made to clarify certain sections and to address technical challenges to ensure that proper testing of these devices has been performed. These updated draft guidances do not change the FDA’s fundamental recommendations on means to improve the
accuracy and safe use of blood glucose meters, nor do they change the recommended studies, performance goals, or the pathway to obtain a
<a href="https://na01.safelinks.protection.outlook.com/?url=https%3A%2F%2Fwww.fda.gov%2FMedicalDevices%2FDeviceRegulationandGuidance%2FIVDRegulatoryAssistance%2Fucm124105.htm%3Futm_campaign%3DFDA%2520SEAT%2520Diabetes%2520Update%252011-28-18%26utm_medium%3Demail%26utm_source%3DEloqua%26elqTrackId%3D455c25c553ac4a93afc4fb41493b2f6a%26elq%3Dd0742e119fbd4f37ad5191def1e5e9ee%26elqaid%3D6072%26elqat%3D1%26elqCampaignId%3D4936&data=01%7C01%7Cyasmin.reyazuddin%40montgomerycountymd.gov%7C3a804bc851974a0161c308d656072eb6%7C6e01b1f9b1e54073ac97778069a0ad64%7C1&sdata=hfzjZx8gPamMEUJx6RuRFFoXBQ10EKVjZm%2FprpDMBD0%3D&reserved=0">
Clinical Laboratory Improvement Amendments waiver</a>.<br>
<br>
When finalized, these guidances will replace the final guidances issued in October 2016.<br>
<br>
The updated draft guidances demonstrate our commitment to ensure that blood glucose monitors are safe, and work as expected. We encourage you to become familiar with these draft guidance documents and to establish open lines of communication with device manufacturers
and with others in your health care setting, including patients, to ensure your facility is equipped with the correct blood glucose meters that will provide the best care to patients. Comments on the proposed changes may be submitted to Federal Register by
February 28, 2019 under docket numbers <a href="https://na01.safelinks.protection.outlook.com/?url=http%3A%2F%2Fapp.info.fda.gov%2Fe%2Fer%3Futm_campaign%3DFDA%2520SEAT%2520Diabetes%2520Update%252011-28-18%26utm_medium%3Demail%26utm_source%3DEloqua%26s%3D2027422842%26lid%3D5791%26elqTrackId%3Db27168a330b3449b81c0e7ae180a6197%26elq%3Dd0742e119fbd4f37ad5191def1e5e9ee%26elqaid%3D6072%26elqat%3D1&data=01%7C01%7Cyasmin.reyazuddin%40montgomerycountymd.gov%7C3a804bc851974a0161c308d656072eb6%7C6e01b1f9b1e54073ac97778069a0ad64%7C1&sdata=wGONZfygO%2BCj39jurQ1DR%2FrJF%2BA6WNvbm8IygY2C8rg%3D&reserved=0">
FDA-2013-D-1445</a> and <a href="https://na01.safelinks.protection.outlook.com/?url=http%3A%2F%2Fapp.info.fda.gov%2Fe%2Fer%3Futm_campaign%3DFDA%2520SEAT%2520Diabetes%2520Update%252011-28-18%26utm_medium%3Demail%26utm_source%3DEloqua%26s%3D2027422842%26lid%3D5790%26elqTrackId%3Dc1e9796a5d5c4b37bcef699f05f27549%26elq%3Dd0742e119fbd4f37ad5191def1e5e9ee%26elqaid%3D6072%26elqat%3D1&data=01%7C01%7Cyasmin.reyazuddin%40montgomerycountymd.gov%7C3a804bc851974a0161c308d656072eb6%7C6e01b1f9b1e54073ac97778069a0ad64%7C1&sdata=qmK0ahAACXqkUg8idAjGR9eHODhA%2Fz9WpJKZyKg3rXQ%3D&reserved=0">
FDA-2013-D-1446</a>.</span><br>
<br>
<span style="font-size:10.5pt;font-family:"Arial",sans-serif"> <br>
<strong><span style="font-family:"Arial",sans-serif">Questions?</span></strong><br>
If you have any questions regarding these guidance documents, please contact the <a href="https://na01.safelinks.protection.outlook.com/?url=https%3A%2F%2Fwww.fda.gov%2FMedicalDevices%2FDeviceRegulationandGuidance%2FContactDivisionofIndustryandConsumerEducation%2Fdefault.htm%3Futm_campaign%3DFDA%2520SEAT%2520Diabetes%2520Update%252011-28-18%26utm_medium%3Demail%26utm_source%3DEloqua%26elqTrackId%3Dbec28b351173445bb43ee54b1cbd4bfe%26elq%3Dd0742e119fbd4f37ad5191def1e5e9ee%26elqaid%3D6072%26elqat%3D1%26elqCampaignId%3D4936&data=01%7C01%7Cyasmin.reyazuddin%40montgomerycountymd.gov%7C3a804bc851974a0161c308d656072eb6%7C6e01b1f9b1e54073ac97778069a0ad64%7C1&sdata=vQ8O%2BFq5jn%2F1GKGiyUu%2F2WBxLljEcmHjz3Ef%2Fd3xh8I%3D&reserved=0">
Division of Industry and Consumer Education (DICE)</a> in the Center for Devices and Radiological Health (CDRH) at 1-800-638-2014, 301-796-7100 or
<a href="mailto:DICE@fda.hhs.gov">DICE@fda.hhs.gov</a></span><o:p></o:p></p>
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<p align="center" style="text-align:center"><span style="font-size:7.5pt;font-family:"Arial",sans-serif">U.S. Food and Drug Administration<br>
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