“ This policy reflects FDA ’ s commitment to ease burdens on health care providers & facilities as they face this public health emergency. ” – @DrAbernethyFDA
“This policy reflects FDA’s commitment to ease burdens on health care providers & facilities as they face this public health emergency.” – @DrAbernethyFDA (Source: Food and Drug Adminstration (FDA): CDRHNew)
Source: Food and Drug Adminstration (FDA): CDRHNew - March 20, 2020 Category: Medical Devices Authors: ( at SteveFDA) Source Type: news

Today, FDA issued a policy allowing manufacturers of certain FDA-cleared, non-invasive, vital-sign-measuring devices to expand their use so that health care providers can use them to monitor patients remotely. http://www.fda.gov/news-events/press-announcements/coronavirus-covid-19-update-fda-allows-expanded-use-devices-monitor-patients-vital-signs-remotely   … pic.twitter.com/O4ehpo79JC
Today, FDA issued a policy allowing manufacturers of certain FDA-cleared, non-invasive, vital-sign-measuring devices to expand their use so that health care providers can use them to monitor patients remotely. http://www.fda.gov/news-events/press-announcements/coronavirus-covid-19-update-fda-allows-expanded-use-devices-monitor-patients-vital-signs-remotely … pic.twitter.com/O4ehpo79JC (Source: Food and Drug Adminstration (FDA): CDRHNew)
Source: Food and Drug Adminstration (FDA): CDRHNew - March 20, 2020 Category: Medical Devices Authors: ( at SteveFDA) Source Type: news

Allowing devices that measure vital signs like body temperature, respiratory rate, heart rate & blood pressure can help health care providers get information from a patient at home, reducing the need for hospital visits & minimizing risk of exposure to #coronavirus.
Allowing devices that measure vital signs like body temperature, respiratory rate, heart rate & blood pressure can help health care providers get information from a patient at home, reducing the need for hospital visits & minimizing risk of exposure to #coronavirus. (Source: Food and Drug Adminstration (FDA): CDRHNew)
Source: Food and Drug Adminstration (FDA): CDRHNew - March 20, 2020 Category: Medical Devices Authors: ( at SteveFDA) Source Type: news

Feeling stressed or anxious about #COVID19? Make time to do activities that you enjoy and can help you relax. https://bit.ly/2TxN9Hb   pic.twitter.com/5fEaeoJ4wT
Feeling stressed or anxious about #COVID19? Make time to do activities that you enjoy and can help you relax. https://bit.ly/2TxN9Hb  pic.twitter.com/5fEaeoJ4wT (Source: Food and Drug Adminstration (FDA): CDRHNew)
Source: Food and Drug Adminstration (FDA): CDRHNew - March 20, 2020 Category: Medical Devices Authors: ( at CDCgov) Source Type: news

Flagging for all developers of tests for SARS-CoV-2. We will be hosting a virtual Town Hall on March 25 from 3P-4P Eastern Time to help answer technical questions about the development and validation of tests for SARS-CoV-2 and the recently issued guidance https://www.fda.gov/medical-devices/workshops-conferences-medical-devices/medical-device-webinars-and-stakeholder-calls   … pic.twitter.com/JMgie7AsNA
Flagging for all developers of tests for SARS-CoV-2. We will be hosting a virtual Town Hall on March 25 from 3P-4P Eastern Time to help answer technical questions about the development and validation of tests for SARS-CoV-2 and the recently issued guidance https://www.fda.gov/medical-devices/workshops-conferences-medical-devices/medical-device-webinars-and-stakeholder-calls … pic.twitter.com/JMgie7AsNA (Source: Food and Drug Adminstration (FDA): CDRHNew)
Source: Food and Drug Adminstration (FDA): CDRHNew - March 20, 2020 Category: Medical Devices Authors: ( at FDADeviceInfo) Source Type: news

We just updated our FAQs for diagnostic testing of #COVID19 to include additional information on alternative transport media and swab options as well as information about what laboratories and manufacturers are offering tests for COVID-19. https://www.fda.gov/medical-devices/emergency-situations-medical-devices/faqs-diagnostic-testing-sars-cov-2?utm_source=CDRHTwitterD   …
We just updated our FAQs for diagnostic testing of #COVID19 to include additional information on alternative transport media and swab options as well as information about what laboratories and manufacturers are offering tests for COVID-19. https://www.fda.gov/medical-devices/emergency-situations-medical-devices/faqs-diagnostic-testing-sars-cov-2?utm_source=CDRHTwitterD … (Source: Food and Drug Adminstration (FDA): CDRHNew)
Source: Food and Drug Adminstration (FDA): CDRHNew - March 20, 2020 Category: Medical Devices Authors: ( at FDADeviceInfo) Source Type: news

Stay tuned for future Master File acceptances as the FDA continues in its efforts to reduce over-reliance on ethylene oxide for medical device sterilization.
(Source: Food and Drug Adminstration (FDA): CDRHNew)
Source: Food and Drug Adminstration (FDA): CDRHNew - March 20, 2020 Category: Medical Devices Authors: ( at FDAMedia) Source Type: news

FDA believes the Ethylene Oxide Sterilization Master File Pilot Program should result in sterilization facilities using a greatly reduced amount of ethylene oxide while still providing robust patient safeguards.
(Source: Food and Drug Adminstration (FDA): CDRHNew)
Source: Food and Drug Adminstration (FDA): CDRHNew - March 20, 2020 Category: Medical Devices Authors: ( at FDAMedia) Source Type: news

Today, as part of our ongoing efforts to expedite approvals of certain changes to ethylene oxide sterilization processes & facilities, the FDA posted the acceptance of its 1st Master File into the FDA Ethylene Oxide Sterilization Master File Pilot Program. https://www.fda.gov/medical-devices/general-hospital-devices-and-supplies/ethylene-oxide-sterilization-medical-devices   …
Today, as part of our ongoing efforts to expedite approvals of certain changes to ethylene oxide sterilization processes & facilities, the FDA posted the acceptance of its 1st Master File into the FDA Ethylene Oxide Sterilization Master File Pilot Program. https://www.fda.gov/medical-devices/general-hospital-devices-and-supplies/ethylene-oxide-sterilization-medical-devices … (Source: Food and Drug Adminstration (FDA): CDRHNew)
Source: Food and Drug Adminstration (FDA): CDRHNew - March 20, 2020 Category: Medical Devices Authors: ( at FDAMedia) Source Type: news

WATCH LIVE: Members of the Coronavirus Task Force hold a press briefing at the @WhiteHouse. https://twitter.com/WhiteHouse/status/1241029433990905857   …
WATCH LIVE: Members of the Coronavirus Task Force hold a press briefing at the @WhiteHouse. https://twitter.com/WhiteHouse/status/1241029433990905857 … (Source: Food and Drug Adminstration (FDA): CDRHNew)
Source: Food and Drug Adminstration (FDA): CDRHNew - March 20, 2020 Category: Medical Devices Authors: ( at US_FDA) Source Type: news

As part of FDA ’ s ongoing commitment to address the #COVID19 pandemic, the agency issued two guidance documents on the production of alcohol-based hand sanitizers to boost supply and protect Americans ’ health during the public health emergency. https://www.fda.gov/news-events/press-announcements/coronavirus-covid-19-update-fda-provides-guidance-production-alcohol-based-hand-sanitizer-help-boost   … pic.twitter.com/0bV8hrwCuV
As part of FDA’s ongoing commitment to address the #COVID19 pandemic, the agency issued two guidance documents on the production of alcohol-based hand sanitizers to boost supply and protect Americans’ health during the public health emergency. https://www.fda.gov/news-events/press-announcements/coronavirus-covid-19-update-fda-provides-guidance-production-alcohol-based-hand-sanitizer-help-boost … pic.twitter.com/0bV8hrwCuV (Source: Food and Drug Adminstration (FDA): CDRHNew)
Source: Food and Drug Adminstration (FDA): CDRHNew - March 20, 2020 Category: Medical Devices Authors: ( at SteveFDA) Source Type: news

FDA continues its work with the public & private sectors to facilitate the availability of potentially safe & effective life-saving drugs to patients who are in need of treatment, including those infected with #COVID19 https://www.fda.gov/news-events/press-announcements/coronavirus-covid-19-update-fda-continues-facilitate-development-treatments   … https://twitter.com/SteveFDA/status/1241002801372770305   …
FDA continues its work with the public & private sectors to facilitate the availability of potentially safe & effective life-saving drugs to patients who are in need of treatment, including those infected with #COVID19 https://www.fda.gov/news-events/press-announcements/coronavirus-covid-19-update-fda-continues-facilitate-development-treatments … https://twitter.com/SteveFDA/status/1241002801372770305 … (Source: Food and Drug Adminstration (FDA): CDRHNew)
Source: Food and Drug Adminstration (FDA): CDRHNew - March 20, 2020 Category: Medical Devices Authors: ( at US_FDA) Source Type: news

Today, FDA issued diagnostic EUAs to GenMark Diagnostics, Inc. for its ePlex SARS-CoV-2 Test and Diasorin Molecular LLC for its Simplexa COVID-19 Direct https://www.fda.gov/medical-devices/emergency-situations-medical-devices/emergency-use-authorizations#covid19ivd   … pic.twitter.com/yMY3zf8PbH
Today, FDA issued diagnostic EUAs to GenMark Diagnostics, Inc. for its ePlex SARS-CoV-2 Test and Diasorin Molecular LLC for its Simplexa COVID-19 Direct https://www.fda.gov/medical-devices/emergency-situations-medical-devices/emergency-use-authorizations#covid19ivd … pic.twitter.com/yMY3zf8PbH (Source: Food and Drug Adminstration (FDA): CDRHNew)
Source: Food and Drug Adminstration (FDA): CDRHNew - March 20, 2020 Category: Medical Devices Authors: ( at SteveFDA) Source Type: news

Here are steps that every American should take to slow the spread of the #coronavirus. For the latest information from the @CDCgov, visit http://coronavirus.gov   .pic.twitter.com/wOqj0N4Sc6
Here are steps that every American should take to slow the spread of the #coronavirus. For the latest information from the @CDCgov, visit http://coronavirus.gov . pic.twitter.com/wOqj0N4Sc6 (Source: Food and Drug Adminstration (FDA): CDRHNew)
Source: Food and Drug Adminstration (FDA): CDRHNew - March 19, 2020 Category: Medical Devices Authors: ( at SecAzar) Source Type: news

Together, we can stop the spread of #COVID19. Here are the most recent guidelines for Americans from the @WhiteHouse and @CDCgov. #coronaviruspic.twitter.com/4xEKCYiU1M
Together, we can stop the spread of #COVID19. Here are the most recent guidelines for Americans from the @WhiteHouse and @CDCgov. #coronavirus pic.twitter.com/4xEKCYiU1M (Source: Food and Drug Adminstration (FDA): CDRHNew)
Source: Food and Drug Adminstration (FDA): CDRHNew - March 19, 2020 Category: Medical Devices Authors: ( at HHSGov) Source Type: news

FDA is working around the clock with developers of #COVID19 diagnostics during this public health emergency. Developers can contact us: 1-888-INFO-FDA (Press *) with questions related to #coronavirus diagnostics or check our FAQs. https://www.fda.gov/medical-devices/emergency-situations-medical-devices/faqs-diagnostic-testing-sars-cov-2   …
FDA is working around the clock with developers of #COVID19 diagnostics during this public health emergency. Developers can contact us: 1-888-INFO-FDA (Press *) with questions related to #coronavirus diagnostics or check our FAQs. https://www.fda.gov/medical-devices/emergency-situations-medical-devices/faqs-diagnostic-testing-sars-cov-2 … (Source: Food and Drug Adminstration (FDA): CDRHNew)
Source: Food and Drug Adminstration (FDA): CDRHNew - March 19, 2020 Category: Medical Devices Authors: ( at SteveFDA) Source Type: news

Today, FDA issued a diagnostic EUA to Abbott Molecular for its RealTime SARS-CoV-2 assay https://www.fda.gov/medical-devices/emergency-situations-medical-devices/emergency-use-authorizations#covid19ivd   … pic.twitter.com/XMzbLN6go4
Today, FDA issued a diagnostic EUA to Abbott Molecular for its RealTime SARS-CoV-2 assay https://www.fda.gov/medical-devices/emergency-situations-medical-devices/emergency-use-authorizations#covid19ivd … pic.twitter.com/XMzbLN6go4 (Source: Food and Drug Adminstration (FDA): CDRHNew)
Source: Food and Drug Adminstration (FDA): CDRHNew - March 19, 2020 Category: Medical Devices Authors: ( at SteveFDA) Source Type: news

For the well-being of our staff & those who conduct inspections for the agency under state contract, & because of industry concerns about visitors, we have temporarily postponed all domestic surveillance facility inspections during the #COVID19 pandemic. https://www.fda.gov/news-events/press-announcements/coronavirus-covid-19-update-fda-focuses-safety-regulated-products-while-scaling-back-domestic   … pic.twitter.com/GwcR7RXwrg
For the well-being of our staff & those who conduct inspections for the agency under state contract, & because of industry concerns about visitors, we have temporarily postponed all domestic surveillance facility inspections during the #COVID19 pandemic. https://www.fda.gov/news-events/press-announcements/coronavirus-covid-19-update-fda-focuses-safety-regulated-products-while-scaling-back-domestic … pic.twitter.com/GwcR7RXwrg (Source: Food and Drug Adminstration (FDA): CDRHNew)
Source: Food and Drug Adminstration (FDA): CDRHNew - March 19, 2020 Category: Medical Devices Authors: ( at SteveFDA) Source Type: news

In an effort to help ensure increased availability of #COVID19 tests throughout the country, we are enacting a policy for states to take responsibility for tests developed & used by laboratories in their states: https://www.fda.gov/news-events/press-announcements/coronavirus-covid-19-update-fda-provides-more-regulatory-relief-during-outbreak-continues-help   …
In an effort to help ensure increased availability of #COVID19 tests throughout the country, we are enacting a policy for states to take responsibility for tests developed & used by laboratories in their states: https://www.fda.gov/news-events/press-announcements/coronavirus-covid-19-update-fda-provides-more-regulatory-relief-during-outbreak-continues-help … (Source: Food and Drug Adminstration (FDA): CDRHNew)
Source: Food and Drug Adminstration (FDA): CDRHNew - March 18, 2020 Category: Medical Devices Authors: ( at SteveFDA) Source Type: news

Important point from Ambassador Birx at today ’ s #Coronavirus briefing: Data emerging from Europe shows millennials may be affected/hospitalized more than previously thought.That ’ s why we MUST adhere to @POTUS guidelines for social distancing. Protect yourself and your community! https://twitter.com/Surgeon_General/status/1239651934069501955   …
Important point from Ambassador Birx at today’s #Coronavirus briefing: Data emerging from Europe shows millennials may be affected/hospitalized more than previously thought.That’s why we MUST adhere to @POTUS guidelines for social distancing. Protect yourself and your community! https://twitter.com/Surgeon_General/status/1239651934069501955 … (Source: Food and Drug Adminstration (FDA): CDRHNew)
Source: Food and Drug Adminstration (FDA): CDRHNew - March 18, 2020 Category: Medical Devices Authors: ( at Surgeon_General) Source Type: news

Today, FDA issued diagnostic EUAs to Quidel Corporation for its Lyra SARS-CoV-2 Assay & Quest Diagnostics Infectious Disease, Inc. for its SARS-CoV-2 rRT-PCR Test https://www.fda.gov/medical-devices/emergency-situations-medical-devices/emergency-use-authorizations#covid19ivd   … pic.twitter.com/sYiKSHDpGg
Today, FDA issued diagnostic EUAs to Quidel Corporation for its Lyra SARS-CoV-2 Assay & Quest Diagnostics Infectious Disease, Inc. for its SARS-CoV-2 rRT-PCR Test https://www.fda.gov/medical-devices/emergency-situations-medical-devices/emergency-use-authorizations#covid19ivd … pic.twitter.com/sYiKSHDpGg (Source: Food and Drug Adminstration (FDA): CDRHNew)
Source: Food and Drug Adminstration (FDA): CDRHNew - March 18, 2020 Category: Medical Devices Authors: ( at SteveFDA) Source Type: news

There is no evidence of food or food packaging being associated with transmission of COVID-19. Nevertheless, we ’ ve posted a series of Q & A related to the topic for the food industry. http://www.fda.gov/food/food-safety-during-emergencies/food-safety-and-coronavirus-disease-2019-covid-19   … pic.twitter.com/WwYHqtG4qN
There is no evidence of food or food packaging being associated with transmission of COVID-19. Nevertheless, we’ve posted a series of Q&A related to the topic for the food industry. http://www.fda.gov/food/food-safety-during-emergencies/food-safety-and-coronavirus-disease-2019-covid-19 … pic.twitter.com/WwYHqtG4qN (Source: Food and Drug Adminstration (FDA): CDRHNew)
Source: Food and Drug Adminstration (FDA): CDRHNew - March 18, 2020 Category: Medical Devices Authors: ( at FrankYiannasFDA) Source Type: news

Check out the recent updates to the FAQs for diagnostic testing of #COVID19 following yesterday ’ s update to the Policy for Diagnostic Tests for Coronavirus Disease-2019 during the Public Health Emergency. https://go.usa.gov/xdtvX  
Check out the recent updates to the FAQs for diagnostic testing of #COVID19 following yesterday’s update to the Policy for Diagnostic Tests for Coronavirus Disease-2019 during the Public Health Emergency. https://go.usa.gov/xdtvX  (Source: Food and Drug Adminstration (FDA): CDRHNew)
Source: Food and Drug Adminstration (FDA): CDRHNew - March 17, 2020 Category: Medical Devices Authors: ( at FDADeviceInfo) Source Type: news

FDA is aware that as the #COVID19 outbreak continues to expand globally, the supply chain for surgical gowns & masks will continue to be stressed if demand exceeds available supplies. Read more on potential shortages of protective personal equipment: https://www.fda.gov/medical-devices/personal-protective-equipment-infection-control/faqs-shortages-surgical-masks-and-gowns   …
FDA is aware that as the #COVID19 outbreak continues to expand globally, the supply chain for surgical gowns & masks will continue to be stressed if demand exceeds available supplies. Read more on potential shortages of protective personal equipment: https://www.fda.gov/medical-devices/personal-protective-equipment-infection-control/faqs-shortages-surgical-masks-and-gowns … (Source: Food and Drug Adminstration (FDA): CDRHNew)
Source: Food and Drug Adminstration (FDA): CDRHNew - March 17, 2020 Category: Medical Devices Authors: ( at US_FDA) Source Type: news

I ’ m pleased to report, through the swift action of the @US_FDA, state health authorities can authorize labs in their state to perform Coronavirus testing.pic.twitter.com/HDt56wZIvp
I’m pleased to report, through the swift action of the @US_FDA, state health authorities can authorize labs in their state to perform Coronavirus testing. pic.twitter.com/HDt56wZIvp (Source: Food and Drug Adminstration (FDA): CDRHNew)
Source: Food and Drug Adminstration (FDA): CDRHNew - March 17, 2020 Category: Medical Devices Authors: ( at Mike_Pence) Source Type: news

The @US_FDA welcomes input from all interested stakeholders including @CPathInstitute, @AmerAcadPeds @AdvaMedUpdate, @MilkenInstitute to enhance the pediatric #MedicalDevice ecosystem.
(Source: Food and Drug Adminstration (FDA): CDRHNew)
Source: Food and Drug Adminstration (FDA): CDRHNew - March 17, 2020 Category: Medical Devices Authors: ( at FDADeviceInfo) Source Type: news

“ Today ’ s health care system has yet to solve the issue of medical device development for children. We welcome input from all stakeholders as we build on our proposed framework and lead together for children ” – Vasum Peiris, MD, MPH, CDRH #Devices4Kids #Pediatrics #MedicalDevicepic.twitter.com/sqygd2MJJy
“Today’s health care system has yet to solve the issue of medical device development for children. We welcome input from all stakeholders as we build on our proposed framework and lead together for children” –Vasum Peiris, MD, MPH, CDRH #Devices4Kids #Pediatrics #MedicalDevice pic.twitter.com/sqygd2MJJy (Source: Food and Drug Adminstration (FDA): CDRHNew)
Source: Food and Drug Adminstration (FDA): CDRHNew - March 17, 2020 Category: Medical Devices Authors: ( at FDADeviceInfo) Source Type: news

CDRH ’ s proposed framework lays out a vision to facilitate development of a viable ecosystem that supports and accelerates #MedicalDevice design, development, evaluation, and commercialization for children.pic.twitter.com/LycCcGJOCK
CDRH’s proposed framework lays out a vision to facilitate development of a viable ecosystem that supports and accelerates #MedicalDevice design, development, evaluation, and commercialization for children. pic.twitter.com/LycCcGJOCK (Source: Food and Drug Adminstration (FDA): CDRHNew)
Source: Food and Drug Adminstration (FDA): CDRHNew - March 17, 2020 Category: Medical Devices Authors: ( at FDADeviceInfo) Source Type: news

Today, the @US_FDA announces that @CPathInstitute (C-Path) was awarded a grant to lead multi-stakeholder engagement on @US_FDA ’ s proposed novel framework to enhance the pediatric #MedicalDevice ecosystem. #Devices4Kids #pediatrics https://bit.ly/33o6MG2  
Today, the @US_FDA announces that @CPathInstitute (C-Path) was awarded a grant to lead multi-stakeholder engagement on @US_FDA’s proposed novel framework to enhance the pediatric #MedicalDevice ecosystem. #Devices4Kids #pediatrics https://bit.ly/33o6MG2  (Source: Food and Drug Adminstration (FDA): CDRHNew)
Source: Food and Drug Adminstration (FDA): CDRHNew - March 17, 2020 Category: Medical Devices Authors: ( at FDADeviceInfo) Source Type: news

This includes: Swabs Transport media Extraction reagents Controls PCR reagents Test kits Instruments #coronavirus @FDADeviceInfo
This includes: Swabs Transport media Extraction reagents Controls PCR reagents Test kits Instruments #coronavirus @FDADeviceInfo (Source: Food and Drug Adminstration (FDA): CDRHNew)
Source: Food and Drug Adminstration (FDA): CDRHNew - March 17, 2020 Category: Medical Devices Authors: ( at AnandShahFDA) Source Type: news

.@US_FDA suggests companies make public their inventory, production schedule and a hotline number to address questions regarding availability of reagents and other supplies needed for #COVID19 testing. If you have an allocation plan to maximize efficient testing, please post.pic.twitter.com/LdX3P7ZT1m
. @US_FDA suggests companies make public their inventory, production schedule and a hotline number to address questions regarding availability of reagents and other supplies needed for #COVID19 testing. If you have an allocation plan to maximize efficient testing, please post. pic.twitter.com/LdX3P7ZT1m (Source: Food and Drug Adminstration (FDA): CDRHNew)
Source: Food and Drug Adminstration (FDA): CDRHNew - March 17, 2020 Category: Medical Devices Authors: ( at AnandShahFDA) Source Type: news

Whether you have 2020 vision, wear glasses or use #ContactLenses, it ’ s important to get regular eye exams. Here are some tips for keeping your eyes healthy to #SaveYourVision for years to come. http://go.usa.gov/xdKNV   #SaveYourVisionMonthpic.twitter.com/xZAAIMjVRD
Whether you have 2020 vision, wear glasses or use #ContactLenses, it’s important to get regular eye exams. Here are some tips for keeping your eyes healthy to #SaveYourVision for years to come. http://go.usa.gov/xdKNV  #SaveYourVisionMonth pic.twitter.com/xZAAIMjVRD (Source: Food and Drug Adminstration (FDA): CDRHNew)
Source: Food and Drug Adminstration (FDA): CDRHNew - March 17, 2020 Category: Medical Devices Authors: ( at FDAWomen) Source Type: news

Today, FDA took two additional significant diagnostic actions during the #COVID19 outbreak by issuing two Emergency Use Authorizations (EUAs). http://www.fda.gov/news-events/press-announcements/coronavirus-covid-19-update-fda-issues-diagnostic-emergency-use-authorization-hologic-and-labcorp   … pic.twitter.com/oHaf26Yuwu
Today, FDA took two additional significant diagnostic actions during the #COVID19 outbreak by issuing two Emergency Use Authorizations (EUAs). http://www.fda.gov/news-events/press-announcements/coronavirus-covid-19-update-fda-issues-diagnostic-emergency-use-authorization-hologic-and-labcorp … pic.twitter.com/oHaf26Yuwu (Source: Food and Drug Adminstration (FDA): CDRHNew)
Source: Food and Drug Adminstration (FDA): CDRHNew - March 17, 2020 Category: Medical Devices Authors: ( at SteveFDA) Source Type: news

Check out the recent updates to the FAQs for diagnostic testing of #COVID19 related to the use of extraction platforms referenced in the authorization of CDC ’ s EUA-authorized test. https://go.usa.gov/xde6y  
Check out the recent updates to the FAQs for diagnostic testing of #COVID19 related to the use of extraction platforms referenced in the authorization of CDC’s EUA-authorized test. https://go.usa.gov/xde6y  (Source: Food and Drug Adminstration (FDA): CDRHNew)
Source: Food and Drug Adminstration (FDA): CDRHNew - March 16, 2020 Category: Medical Devices Authors: ( at FDADeviceInfo) Source Type: news

Social distancing can help slow the spread of #COVID19 in affected communities. This means avoiding crowded places and maintaining distance from others. More prevention tips: https://bit.ly/2QbLFkW   .pic.twitter.com/IQjSwRxIzn
Social distancing can help slow the spread of #COVID19 in affected communities. This means avoiding crowded places and maintaining distance from others. More prevention tips: https://bit.ly/2QbLFkW . pic.twitter.com/IQjSwRxIzn (Source: Food and Drug Adminstration (FDA): CDRHNew)
Source: Food and Drug Adminstration (FDA): CDRHNew - March 16, 2020 Category: Medical Devices Authors: ( at CDCgov) Source Type: news

Yesterday, @US_FDA re-issued an emergency use authorization to @CDCgov for their #COVID19 diagnostic test with amendments intended to help expand test and component availability and reduce the time to final results. https://www.fda.gov/medical-devices/emergency-situations-medical-devices/emergency-use-authorizations#coronavirus2019   …
Yesterday, @US_FDA re-issued an emergency use authorization to @CDCgov for their #COVID19 diagnostic test with amendments intended to help expand test and component availability and reduce the time to final results. https://www.fda.gov/medical-devices/emergency-situations-medical-devices/emergency-use-authorizations#coronavirus2019 … (Source: Food and Drug Adminstration (FDA): CDRHNew)
Source: Food and Drug Adminstration (FDA): CDRHNew - March 16, 2020 Category: Medical Devices Authors: ( at SteveFDA) Source Type: news

Was honored to stand with members of the U.S. Public Health Service #CommissionedCorps at the @WhiteHouse podium last night. They are America's public health heroes, bringing medical expertise and compassion to combat #COVID19. @HHS_ASH #USPHS #AmericasHealthResponderspic.twitter.com/0GCJHLoLv7
Was honored to stand with members of the U.S. Public Health Service #CommissionedCorps at the @WhiteHouse podium last night. They are America's public health heroes, bringing medical expertise and compassion to combat #COVID19. @HHS_ASH #USPHS #AmericasHealthResponders pic.twitter.com/0GCJHLoLv7 (Source: Food and Drug Adminstration (FDA): CDRHNew)
Source: Food and Drug Adminstration (FDA): CDRHNew - March 16, 2020 Category: Medical Devices Authors: ( at SecAzar) Source Type: news

New: Starting immediately and for the next 8 weeks, CDC recommends cancelling all events of 50 or more people. Full recommendation here: https://bit.ly/3ahDsU2   #COVID19pic.twitter.com/OroIqhTYJo
New: Starting immediately and for the next 8 weeks, CDC recommends cancelling all events of 50 or more people. Full recommendation here: https://bit.ly/3ahDsU2  #COVID19 pic.twitter.com/OroIqhTYJo (Source: Food and Drug Adminstration (FDA): CDRHNew)
Source: Food and Drug Adminstration (FDA): CDRHNew - March 16, 2020 Category: Medical Devices Authors: ( at CDCgov) Source Type: news

FDA plays a critical role in protecting the US from threats including infectious diseases. We oversee our nation ’ s medical products & diagnostic test development as part of our vital mission to protect & promote public health, including during public health emergencies. #COVID19
FDA plays a critical role in protecting the US from threats including infectious diseases. We oversee our nation’s medical products & diagnostic test development as part of our vital mission to protect & promote public health, including during public health emergencies. #COVID19 (Source: Food and Drug Adminstration (FDA): CDRHNew)
Source: Food and Drug Adminstration (FDA): CDRHNew - March 16, 2020 Category: Medical Devices Authors: ( at SteveFDA) Source Type: news

1) We want to prioritize the most vulnerable and most impacted. 2) We don't want testing to threaten the acute care system. 3) We want to balance the need for resources across the healthcare system between diagnosis and treatment. More from Admiral Brett Giroir:pic.twitter.com/lrZJ4qJMsb
1) We want to prioritize the most vulnerable and most impacted. 2) We don't want testing to threaten the acute care system. 3) We want to balance the need for resources across the healthcare system between diagnosis and treatment. More from Admiral Brett Giroir: pic.twitter.com/lrZJ4qJMsb (Source: Food and Drug Adminstration (FDA): CDRHNew)
Source: Food and Drug Adminstration (FDA): CDRHNew - March 16, 2020 Category: Medical Devices Authors: ( at WhiteHouse) Source Type: news

FDA is aware that as the #COVID19 outbreak continues to expand globally, the supply chain for surgical gowns & masks will continue to be stressed if demand exceeds available supplies. Read more on potential shortages of protective personal equipment: https://www.fda.gov/medical-devices/personal-protective-equipment-infection-control/faqs-shortages-surgical-masks-and-gowns   …
FDA is aware that as the #COVID19 outbreak continues to expand globally, the supply chain for surgical gowns & masks will continue to be stressed if demand exceeds available supplies. Read more on potential shortages of protective personal equipment: https://www.fda.gov/medical-devices/personal-protective-equipment-infection-control/faqs-shortages-surgical-masks-and-gowns … (Source: Food and Drug Adminstration (FDA): CDRHNew)
Source: Food and Drug Adminstration (FDA): CDRHNew - March 15, 2020 Category: Medical Devices Authors: ( at SteveFDA) Source Type: news

Everyone has a role to play to reduce and slow transmission of #COVID19. Social distancing is one way to prevent the spread of COVID-19. This means avoiding crowded places and maintaining distance from others when possible. More prevention tips: https://bit.ly/2QbLFkW   .pic.twitter.com/AeEZMPO4oY
Everyone has a role to play to reduce and slow transmission of #COVID19. Social distancing is one way to prevent the spread of COVID-19. This means avoiding crowded places and maintaining distance from others when possible. More prevention tips: https://bit.ly/2QbLFkW . pic.twitter.com/AeEZMPO4oY (Source: Food and Drug Adminstration (FDA): CDRHNew)
Source: Food and Drug Adminstration (FDA): CDRHNew - March 15, 2020 Category: Medical Devices Authors: ( at CDCgov) Source Type: news

Everyone can help prevent the spread of #COVID19. Call your doctor if you develop symptoms, have been in close contact with a person known to have COVID-19, or have recently traveled from an area with widespread or ongoing community spread of COVID-19. https://bit.ly/38zjnYo   pic.twitter.com/Hz49Y1CYg6
Everyone can help prevent the spread of #COVID19. Call your doctor if you develop symptoms, have been in close contact with a person known to have COVID-19, or have recently traveled from an area with widespread or ongoing community spread of COVID-19. https://bit.ly/38zjnYo  pic.twitter.com/Hz49Y1CYg6 (Source: Food and Drug Adminstration (FDA): CDRHNew)
Source: Food and Drug Adminstration (FDA): CDRHNew - March 15, 2020 Category: Medical Devices Authors: ( at CDCgov) Source Type: news

FDA is working with U.S. government partners, including @CDCgov, and international partners to address the #coronavirus disease 2019 (#COVID19) outbreak. For the latest updates, visit our website: https://www.fda.gov/emergency-preparedness-and-response/mcm-issues/coronavirus-disease-2019-covid-19   … pic.twitter.com/fy8A4tNH0n
FDA is working with U.S. government partners, including @CDCgov, and international partners to address the #coronavirus disease 2019 ( #COVID19) outbreak. For the latest updates, visit our website: https://www.fda.gov/emergency-preparedness-and-response/mcm-issues/coronavirus-disease-2019-covid-19 … pic.twitter.com/fy8A4tNH0n (Source: Food and Drug Adminstration (FDA): CDRHNew)
Source: Food and Drug Adminstration (FDA): CDRHNew - March 15, 2020 Category: Medical Devices Authors: ( at US_FDA) Source Type: news

FDA & @CDCgov took action to make more respirators, including certain N95s, available to health care workers. At FDA we ’ re working to mitigate potential shortages in the supply chain, including demand & supply challenges w/ personal protective equipment. https://www.fda.gov/news-events/press-announcements/coronavirus-covid-19-update-fda-and-cdc-take-action-increase-access-respirators-including-n95s   …
FDA & @CDCgov took action to make more respirators, including certain N95s, available to health care workers. At FDA we’re working to mitigate potential shortages in the supply chain, including demand & supply challenges w/ personal protective equipment. https://www.fda.gov/news-events/press-announcements/coronavirus-covid-19-update-fda-and-cdc-take-action-increase-access-respirators-including-n95s … (Source: Food and Drug Adminstration (FDA): CDRHNew)
Source: Food and Drug Adminstration (FDA): CDRHNew - March 15, 2020 Category: Medical Devices Authors: ( at SteveFDA) Source Type: news

FDA ’ s 4th diagnostic Emergency Use Authorization was issued to Thermo Fisher for the TaqPath #COVID19 Combo Kit within 24 hours of FDA receiving the request. We encourage test developers to work with us to improve availability of #COVID19 diagnostics. https://www.fda.gov/medical-devices/emergency-situations-medical-devices/emergency-use-authorizations#covid19ivd   … pic.twitter.com/NOY6NwCmuW
FDA’s 4th diagnostic Emergency Use Authorization was issued to Thermo Fisher for the TaqPath #COVID19 Combo Kit within 24 hours of FDA receiving the request. We encourage test developers to work with us to improve availability of #COVID19 diagnostics. https://www.fda.gov/medical-devices/emergency-situations-medical-devices/emergency-use-authorizations#covid19ivd … pic.twitter.com/NOY6NwCmuW (Source: Food and Drug Adminstration (FDA): CDRHNew)
Source: Food and Drug Adminstration (FDA): CDRHNew - March 14, 2020 Category: Medical Devices Authors: ( at SteveFDA) Source Type: news

Thinking about baking a pie tomorrow for #NationalPiDay? Remember to wash hands, work surfaces, and utensils thoroughly after contact with flour and raw dough products. More baking tips here: https://go.usa.gov/xdsRn   pic.twitter.com/s1StTa3Gmq
Thinking about baking a pie tomorrow for #NationalPiDay? Remember to wash hands, work surfaces, and utensils thoroughly after contact with flour and raw dough products. More baking tips here: https://go.usa.gov/xdsRn  pic.twitter.com/s1StTa3Gmq (Source: Food and Drug Adminstration (FDA): CDRHNew)
Source: Food and Drug Adminstration (FDA): CDRHNew - March 13, 2020 Category: Medical Devices Authors: ( at US_FDA) Source Type: news

FDA is committed to working around the clock to help expedite the availability of #COVID19 tests. Learn about our latest actions to address and expand testing availability: https://go.usa.gov/xdFMu   pic.twitter.com/GqBd5z9CKi
FDA is committed to working around the clock to help expedite the availability of #COVID19 tests. Learn about our latest actions to address and expand testing availability: https://go.usa.gov/xdFMu  pic.twitter.com/GqBd5z9CKi (Source: Food and Drug Adminstration (FDA): CDRHNew)
Source: Food and Drug Adminstration (FDA): CDRHNew - March 13, 2020 Category: Medical Devices Authors: ( at US_FDA) Source Type: news

We are working to ensure that every American who needs a test for #COVID19 will receive it. Honored to lead the coordination of COVID-19 diagnostic testing efforts among #PublicHealth service agencies, including @CDCgov and @US_FDA.
(Source: Food and Drug Adminstration (FDA): CDRHNew)
Source: Food and Drug Adminstration (FDA): CDRHNew - March 13, 2020 Category: Medical Devices Authors: ( at HHS_ASH) Source Type: news

Yesterday, @US_FDA took two significant actions in the agency ’ s ongoing & aggressive commitment to addressing the #coronavirus disease (#COVID19) outbreak. https://go.usa.gov/xdFMu   pic.twitter.com/rXtYxfc5AZ
Yesterday, @US_FDA took two significant actions in the agency’s ongoing & aggressive commitment to addressing the #coronavirus disease ( #COVID19) outbreak. https://go.usa.gov/xdFMu  pic.twitter.com/rXtYxfc5AZ (Source: Food and Drug Adminstration (FDA): CDRHNew)
Source: Food and Drug Adminstration (FDA): CDRHNew - March 13, 2020 Category: Medical Devices Authors: ( at SteveFDA) Source Type: news