[Md-sligo] FW: FDA Stakeholder Update - FDA Takes Steps to Advance the Safety and Accuracy of Blood Glucose Monitoring Test Systems

Thu Nov 29 15:13:36 UTC 2018

I got the following email.
As many people suffer from diabetes and are going blind,  we need to take steps to comment about the testing systems.

Yasmin Reyazuddin, Customer Service Representative II
MC311 Customer Service Center
Office of Public Information
1401 Rockville Pike., Suite #300
Rockville, MD 20852
phone: 240-777-0311
email: yasmin.reyazuddin at montgomerycountymd.gov<mailto:your%20name at montgomerycountymd.gov>

[cid:image001.gif at 01CB0E0B.602FB700][cid:image002.png at 01D23697.CA206D10]

From: U.S. Food and Drug Administration [mailto:fda at info.fda.gov]
Sent: Thursday, November 29, 2018 9:30 AM
To: Reyazuddin, Yasmin <Yasmin.Reyazuddin at montgomerycountymd.gov>
Subject: FDA Stakeholder Update - FDA Takes Steps to Advance the Safety and Accuracy of Blood Glucose Monitoring Test Systems

If your email program has trouble displaying this email, view it as a web page<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>.

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FDA Stakeholder Update - Informing FDA stakeholders on key priorities that advance FDA’s public health mission.
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November 29, 2018
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:

Blood Glucose Monitoring Test Systems for Prescription Point-of-Care Use<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>
This draft guidance document provides recommendations to industry about the types of information to include in their premarket submissions<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> for blood glucose monitoring systems used for diabetes management in the health care setting.

Self-Monitoring Blood Glucose Test Systems for Over-the-Counter Use<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>
This draft guidance document provides recommendations to industry about the studies and criteria to include in their premarket submissions for self-monitoring blood glucose test systems<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> used for diabetes management in the home setting.

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.

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 Clinical Laboratory Improvement Amendments waiver<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>.

When finalized, these guidances will replace the final guidances issued in October 2016.

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 FDA-2013-D-1445<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> and FDA-2013-D-1446<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>.

Questions?
If you have any questions regarding these guidance documents, please contact the Division of Industry and Consumer Education (DICE)<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> in the Center for Devices and Radiological Health (CDRH) at 1-800-638-2014, 301-796-7100 or DICE at fda.hhs.gov<mailto:DICE at fda.hhs.gov>

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