Six steps we can take to help protect our #mentalhealth as we fight #COVID19 together and work to #SlowTheSpread. https://bit.ly/2UF3k7h   #Coronaviruspic.twitter.com/93PVsNZMH3
Six steps we can take to help protect our #mentalhealth as we fight #COVID19 together and work to #SlowTheSpread. https://bit.ly/2UF3k7h  #Coronavirus pic.twitter.com/93PVsNZMH3 (Source: Food and Drug Adminstration (FDA): CDRHNew)
Source: Food and Drug Adminstration (FDA): CDRHNew - April 6, 2020 Category: Medical Devices Authors: ( at SecAzar) Source Type: news

REMINDER: Today from 3-4 PM ET the @US_FDA will host a webinar for device manufacturers & industry to discuss and answer questions on recently issued, immediately in effect guidances on enforcement policy for personal protective equipment during #COVID19 https://go.usa.gov/xvYza   pic.twitter.com/SIsuE9Y5PN
REMINDER: Today from 3-4 PM ET the @US_FDA will host a webinar for device manufacturers & industry to discuss and answer questions on recently issued, immediately in effect guidances on enforcement policy for personal protective equipment during #COVID19 https://go.usa.gov/xvYza  pic.twitter.com/SIsuE9Y5PN (Source: Food and Drug Adminstration (FDA): CDRHNew)
Source: Food and Drug Adminstration (FDA): CDRHNew - April 6, 2020 Category: Medical Devices Authors: ( at FDADeviceInfo) Source Type: news

It takes all of us – together – to #FlattenTheCurve. Follow the Coronavirus Guidelines for America and encourage others to do the same. https://twitter.com/WhiteHouse/status/1246152289577992193   …
It takes all of us – together – to #FlattenTheCurve. Follow the Coronavirus Guidelines for America and encourage others to do the same. https://twitter.com/WhiteHouse/status/1246152289577992193 … (Source: Food and Drug Adminstration (FDA): CDRHNew)
Source: Food and Drug Adminstration (FDA): CDRHNew - April 5, 2020 Category: Medical Devices Authors: ( at US_FDA) Source Type: news

Make sure to clean and disinfect your home as we work together to combat the #COVID19 pandemic. https://twitter.com/CDCgov/status/1246130351379972097   …
Make sure to clean and disinfect your home as we work together to combat the #COVID19 pandemic. https://twitter.com/CDCgov/status/1246130351379972097 … (Source: Food and Drug Adminstration (FDA): CDRHNew)
Source: Food and Drug Adminstration (FDA): CDRHNew - April 5, 2020 Category: Medical Devices Authors: ( at US_FDA) Source Type: news

New Date: On May 5, 2020, @US_FDA will hold a public meeting to discuss proposed recommendations for the reauthorization of MDUFA for FYs 2023 through 2027 (MDUFA V) via webcast #CDRH https://www.regulations.gov/document?D=FDA-2020-N-0907-0003   … pic.twitter.com/moRSerNccI
New Date: On May 5, 2020, @US_FDA will hold a public meeting to discuss proposed recommendations for the reauthorization of MDUFA for FYs 2023 through 2027 (MDUFA V) via webcast #CDRH https://www.regulations.gov/document?D=FDA-2020-N-0907-0003 … pic.twitter.com/moRSerNccI (Source: Food and Drug Adminstration (FDA): CDRHNew)
Source: Food and Drug Adminstration (FDA): CDRHNew - April 3, 2020 Category: Medical Devices Authors: ( at FDADeviceInfo) Source Type: news

Register to attend by May 4th – we look forward to hearing stakeholder views on MDUFA V & suggestions for any changes to the user fee program that @US_FDA should consider https://go.usa.gov/xvYuM  
Register to attend by May 4th – we look forward to hearing stakeholder views on MDUFA V & suggestions for any changes to the user fee program that @US_FDA should consider https://go.usa.gov/xvYuM  (Source: Food and Drug Adminstration (FDA): CDRHNew)
Source: Food and Drug Adminstration (FDA): CDRHNew - April 3, 2020 Category: Medical Devices Authors: ( at FDADeviceInfo) Source Type: news

We ’ ve just updated our FAQs for diagnostic testing of #COVID19 to include more information about tests for use at the point of care and new information about CLIA categorization http://go.usa.gov/xvYv3   pic.twitter.com/MoOR7zjWXq
We’ve just updated our FAQs for diagnostic testing of #COVID19 to include more information about tests for use at the point of care and new information about CLIA categorization http://go.usa.gov/xvYv3  pic.twitter.com/MoOR7zjWXq (Source: Food and Drug Adminstration (FDA): CDRHNew)
Source: Food and Drug Adminstration (FDA): CDRHNew - April 3, 2020 Category: Medical Devices Authors: ( at FDADeviceInfo) Source Type: news

As part of FDA ’ s crucial role in facilitating medical countermeasures to treat & prevent #COVID19, we are working with government, academic & industry partners to facilitate the development of, & access to, investigational therapies made from human blood. https://www.fda.gov/news-events/press-announcements/coronavirus-covid-19-update-fda-coordinates-national-effort-develop-blood-related-therapies-covid-19   … pic.twitter.com/0rpKjmvlz6
As part of FDA’s crucial role in facilitating medical countermeasures to treat & prevent #COVID19, we are working with government, academic & industry partners to facilitate the development of, & access to, investigational therapies made from human blood. https://www.fda.gov/news-events/press-announcements/coronavirus-covid-19-update-fda-coordinates-national-effort-develop-blood-related-therapies-covid-19 … pic.twitter.com/0rpKjmvlz6 (Source: Food and Drug Adminstration (FDA): CDRHNew)
Source: Food and Drug Adminstration (FDA): CDRHNew - April 3, 2020 Category: Medical Devices Authors: ( at SteveFDA) Source Type: news

REMINDER: Flagging for developers of tests for SARS-CoV-2: Virtual Town Hall Series - Immediately in Effect Guidance on Coronavirus (COVID-19) Diagnostic Tests. Wednesday April 8, 2020 12:15-1:15 ET. http://go.usa.gov/xv3hx   pic.twitter.com/lGbSxklga2
REMINDER: Flagging for developers of tests for SARS-CoV-2: Virtual Town Hall Series - Immediately in Effect Guidance on Coronavirus (COVID-19) Diagnostic Tests. Wednesday April 8, 2020 12:15-1:15 ET. http://go.usa.gov/xv3hx  pic.twitter.com/lGbSxklga2 (Source: Food and Drug Adminstration (FDA): CDRHNew)
Source: Food and Drug Adminstration (FDA): CDRHNew - April 3, 2020 Category: Medical Devices Authors: ( at FDADeviceInfo) Source Type: news

If you get a rash or other serious reaction to hand sanitizer, call your doctor and report the side effect to our MedWatch Adverse Event Reporting program here: https://go.usa.gov/xdJUt   .pic.twitter.com/16x0IQQKpL
If you get a rash or other serious reaction to hand sanitizer, call your doctor and report the side effect to our MedWatch Adverse Event Reporting program here: https://go.usa.gov/xdJUt . pic.twitter.com/16x0IQQKpL (Source: Food and Drug Adminstration (FDA): CDRHNew)
Source: Food and Drug Adminstration (FDA): CDRHNew - April 3, 2020 Category: Medical Devices Authors: ( at FDA_Drug_Info) Source Type: news

On April 6, 2020 from 3-4 PM ET the @US_FDA will host a webinar for device manufacturers & industry to discuss and answer questions on recently issued, immediately in effect guidances on enforcement policy for personal protective equipment during #COVID19 https://go.usa.gov/xvYza   pic.twitter.com/IVsUm0IjpU
On April 6, 2020 from 3-4 PM ET the @US_FDA will host a webinar for device manufacturers & industry to discuss and answer questions on recently issued, immediately in effect guidances on enforcement policy for personal protective equipment during #COVID19 https://go.usa.gov/xvYza  pic.twitter.com/IVsUm0IjpU (Source: Food and Drug Adminstration (FDA): CDRHNew)
Source: Food and Drug Adminstration (FDA): CDRHNew - April 3, 2020 Category: Medical Devices Authors: ( at FDADeviceInfo) Source Type: news

While we all are practicing social distancing to #FlattenTheCurve, first responders & health care professionals must remain on the front lines of the #COVID19 pandemic. FDA ’ s own #USPHS officers are focused on protecting the health of the nation. https://www.fda.gov/news-events/fda-voices-perspectives-fda-leadership-and-experts/fda-commissioned-corps-officers-front-line-covid-19-response   …
While we all are practicing social distancing to #FlattenTheCurve, first responders & health care professionals must remain on the front lines of the #COVID19 pandemic. FDA’s own #USPHS officers are focused on protecting the health of the nation. https://www.fda.gov/news-events/fda-voices-perspectives-fda-leadership-and-experts/fda-commissioned-corps-officers-front-line-covid-19-response … (Source: Food and Drug Adminstration (FDA): CDRHNew)
Source: Food and Drug Adminstration (FDA): CDRHNew - April 3, 2020 Category: Medical Devices Authors: ( at US_FDA) Source Type: news

Flagging: We ’ ve updated our FAQs for diagnostic testing of #COVID19 to include more information about alternative instruments. https://go.usa.gov/xvYv3   pic.twitter.com/5TymYOBRwv
Flagging: We’ve updated our FAQs for diagnostic testing of #COVID19 to include more information about alternative instruments. https://go.usa.gov/xvYv3  pic.twitter.com/5TymYOBRwv (Source: Food and Drug Adminstration (FDA): CDRHNew)
Source: Food and Drug Adminstration (FDA): CDRHNew - April 3, 2020 Category: Medical Devices Authors: ( at FDADeviceInfo) Source Type: news

Together, we can #SlowTheSpread. Here are the latest actions FDA has taken in the fight against #COVID19: https://www.fda.gov/news-events/press-announcements/coronavirus-covid-19-update-daily-roundup-april-2-2020   … pic.twitter.com/KXtqshoozY
Together, we can #SlowTheSpread. Here are the latest actions FDA has taken in the fight against #COVID19: https://www.fda.gov/news-events/press-announcements/coronavirus-covid-19-update-daily-roundup-april-2-2020 … pic.twitter.com/KXtqshoozY (Source: Food and Drug Adminstration (FDA): CDRHNew)
Source: Food and Drug Adminstration (FDA): CDRHNew - April 3, 2020 Category: Medical Devices Authors: ( at SteveFDA) Source Type: news

Flagging: We ’ ve just updated our FAQs for diagnostic testing of #COVID19 to include more information about alternatives to nasopharyngeal swabs and media https://go.usa.gov/xvYY9   pic.twitter.com/ydY3UQ72La
Flagging: We’ve just updated our FAQs for diagnostic testing of #COVID19 to include more information about alternatives to nasopharyngeal swabs and media https://go.usa.gov/xvYY9  pic.twitter.com/ydY3UQ72La (Source: Food and Drug Adminstration (FDA): CDRHNew)
Source: Food and Drug Adminstration (FDA): CDRHNew - April 2, 2020 Category: Medical Devices Authors: ( at FDADeviceInfo) Source Type: news

LeMaitre Vascular, Inc. is recalling the Over the Wire Embolectomy Catheter due to a risk of the balloon catheter failing to deflate during use. Find out more about this #MedicalDevice recall. https://go.usa.gov/xvYxR  
LeMaitre Vascular, Inc. is recalling the Over the Wire Embolectomy Catheter due to a risk of the balloon catheter failing to deflate during use. Find out more about this #MedicalDevice recall. https://go.usa.gov/xvYxR  (Source: Food and Drug Adminstration (FDA): CDRHNew)
Source: Food and Drug Adminstration (FDA): CDRHNew - April 2, 2020 Category: Medical Devices Authors: ( at FDADeviceInfo) Source Type: news

Today, the @US_FDA identified a Class I Recall, the most serious type of recall: LeMaitre Vascular Inc. Recalls LeMaitre Over the Wire Embolectomy Catheter Due to Balloon Deflation and Separation Issue.pic.twitter.com/5oGWz05q3P
Today, the @US_FDA identified a Class I Recall, the most serious type of recall: LeMaitre Vascular Inc. Recalls LeMaitre Over the Wire Embolectomy Catheter Due to Balloon Deflation and Separation Issue. pic.twitter.com/5oGWz05q3P (Source: Food and Drug Adminstration (FDA): CDRHNew)
Source: Food and Drug Adminstration (FDA): CDRHNew - April 2, 2020 Category: Medical Devices Authors: ( at FDADeviceInfo) Source Type: news

Finally, we appreciate industry ’ s willingness to help increase hand sanitizer supply to meet the increasing demand for alcohol-based hand sanitizers during the #COVID19 pandemic. We have published guidances to provide flexibility to help meet this demand. https://www.fda.gov/drugs/information-drug-class/qa-consumers-hand-sanitizers-and-covid-19   …
Finally, we appreciate industry’s willingness to help increase hand sanitizer supply to meet the increasing demand for alcohol-based hand sanitizers during the #COVID19 pandemic. We have published guidances to provide flexibility to help meet this demand. https://www.fda.gov/drugs/information-drug-class/qa-consumers-hand-sanitizers-and-covid-19 … (Source: Food and Drug Adminstration (FDA): CDRHNew)
Source: Food and Drug Adminstration (FDA): CDRHNew - April 2, 2020 Category: Medical Devices Authors: ( at SteveFDA) Source Type: news

We work closely with manufacturers to make sure that they continue to notify the FDA about permanent or temporary interruptions in the manufacture of drugs, biologics & animal drugs that could disrupt the supply of these products for patients. https://www.fda.gov/news-events/press-announcements/coronavirus-covid-19-update-fda-takes-further-steps-help-mitigate-supply-interruptions-food-and   … pic.twitter.com/yRIDDdG43M
We work closely with manufacturers to make sure that they continue to notify the FDA about permanent or temporary interruptions in the manufacture of drugs, biologics & animal drugs that could disrupt the supply of these products for patients. https://www.fda.gov/news-events/press-announcements/coronavirus-covid-19-update-fda-takes-further-steps-help-mitigate-supply-interruptions-food-and … pic.twitter.com/yRIDDdG43M (Source: Food and Drug Adminstration (FDA): CDRHNew)
Source: Food and Drug Adminstration (FDA): CDRHNew - April 2, 2020 Category: Medical Devices Authors: ( at SteveFDA) Source Type: news

Huge thanks to the @US_FDA Consumer Safety Officers in the New York imports division who quickly inspected imported shipment of emergency medical supplies to ensure products are safe for medical professionals who urgently need them in #COVID19 response.pic.twitter.com/UN7u4ICQeu
Huge thanks to the @US_FDA Consumer Safety Officers in the New York imports division who quickly inspected imported shipment of emergency medical supplies to ensure products are safe for medical professionals who urgently need them in #COVID19 response. pic.twitter.com/UN7u4ICQeu (Source: Food and Drug Adminstration (FDA): CDRHNew)
Source: Food and Drug Adminstration (FDA): CDRHNew - April 2, 2020 Category: Medical Devices Authors: ( at SteveFDA) Source Type: news

Do you have questions about FDA and the food supply during the #COVID19 pandemic? Rest assured FDA is working tirelessly to keep the food supply safe, and we don ’ t see any shortages in the supply chain at this time. https://go.usa.gov/xvrsp   pic.twitter.com/BGr76KgnPC
Do you have questions about FDA and the food supply during the #COVID19 pandemic? Rest assured FDA is working tirelessly to keep the food supply safe, and we don’t see any shortages in the supply chain at this time. https://go.usa.gov/xvrsp  pic.twitter.com/BGr76KgnPC (Source: Food and Drug Adminstration (FDA): CDRHNew)
Source: Food and Drug Adminstration (FDA): CDRHNew - April 2, 2020 Category: Medical Devices Authors: ( at US_FDA) Source Type: news

Yesterday, FDA and @FTC issued warning letters to 3 companies for selling fraudulent products with claims to prevent, treat, mitigate, diagnose or cure #COVID19. https://www.fda.gov/consumers/health-fraud-scams/fraudulent-coronavirus-disease-2019-covid-19-products   … pic.twitter.com/VLN5H3fMgp
Yesterday, FDA and @FTC issued warning letters to 3 companies for selling fraudulent products with claims to prevent, treat, mitigate, diagnose or cure #COVID19. https://www.fda.gov/consumers/health-fraud-scams/fraudulent-coronavirus-disease-2019-covid-19-products … pic.twitter.com/VLN5H3fMgp (Source: Food and Drug Adminstration (FDA): CDRHNew)
Source: Food and Drug Adminstration (FDA): CDRHNew - April 2, 2020 Category: Medical Devices Authors: ( at SteveFDA) Source Type: news

Today, as part of FDA ’ s ongoing commitment to fight the #COVID19 pandemic, we issued guidance for immediate implementation to address the urgent & immediate need for blood & its components. https://www.fda.gov/news-events/press-announcements/coronavirus-covid-19-update-fda-provides-updated-guidance-address-urgent-need-blood-during-pandemic   … pic.twitter.com/Ub4tk1fkAw
Today, as part of FDA’s ongoing commitment to fight the #COVID19 pandemic, we issued guidance for immediate implementation to address the urgent & immediate need for blood & its components. https://www.fda.gov/news-events/press-announcements/coronavirus-covid-19-update-fda-provides-updated-guidance-address-urgent-need-blood-during-pandemic … pic.twitter.com/Ub4tk1fkAw (Source: Food and Drug Adminstration (FDA): CDRHNew)
Source: Food and Drug Adminstration (FDA): CDRHNew - April 2, 2020 Category: Medical Devices Authors: ( at SteveFDA) Source Type: news

We ’ re providing updated information to keep the American public informed on actions @US_FDA is taking to regulate medical devices used to diagnose, prevent and treat #COVID19. https://www.fda.gov/medical-devices/emergency-situations-medical-devices/medical-devices-and-covid-19-coronavirus-pandemic   …
We’re providing updated information to keep the American public informed on actions @US_FDA is taking to regulate medical devices used to diagnose, prevent and treat #COVID19. https://www.fda.gov/medical-devices/emergency-situations-medical-devices/medical-devices-and-covid-19-coronavirus-pandemic … (Source: Food and Drug Adminstration (FDA): CDRHNew)
Source: Food and Drug Adminstration (FDA): CDRHNew - April 2, 2020 Category: Medical Devices Authors: ( at SteveFDA) Source Type: news

IF you choose to wear a face covering: Wash your hands well before and after, & don ’ t touch your face while wearing Please save the N95 masks for healthcare/ frontline workers Remember it is not a replacement for social distancing. Your best bet is still to stay at home.
IF you choose to wear a face covering: Wash your hands well before and after, & don’t touch your face while wearing Please save the N95 masks for healthcare/ frontline workers Remember it is not a replacement for social distancing. Your best bet is still to stay at home. (Source: Food and Drug Adminstration (FDA): CDRHNew)
Source: Food and Drug Adminstration (FDA): CDRHNew - April 2, 2020 Category: Medical Devices Authors: ( at Surgeon_General) Source Type: news

There remains scant evidence wearing a mask- especially improperly- provides much benefit to a healthy wearer. However emerging data suggests facial coverings may prevent asymptomatic disease transmission to others. We always follow and react to the data - @CDCgov is studying
(Source: Food and Drug Adminstration (FDA): CDRHNew)
Source: Food and Drug Adminstration (FDA): CDRHNew - April 2, 2020 Category: Medical Devices Authors: ( at Surgeon_General) Source Type: news

We continue to pursue those that place public health at risk. With @FTC, we issued a warning letter to Neuro XPF, which sells cannabidiol (CBD) products with the misleading claim these products can mitigate, prevent, treat, diagnose, or cure #COVID19. https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/neuroxpf-606236-03312020   …
We continue to pursue those that place public health at risk. With @FTC, we issued a warning letter to Neuro XPF, which sells cannabidiol (CBD) products with the misleading claim these products can mitigate, prevent, treat, diagnose, or cure #COVID19. https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/neuroxpf-606236-03312020 … (Source: Food and Drug Adminstration (FDA): CDRHNew)
Source: Food and Drug Adminstration (FDA): CDRHNew - April 2, 2020 Category: Medical Devices Authors: ( at SteveFDA) Source Type: news

FDA issued an emergency use authorization (EUA) that authorizes eligible molecular-based laboratory developed tests, or LDTs, that are developed and used by a single CLIA high complexity laboratory. https://www.fda.gov/medical-devices/emergency-situations-medical-devices/emergency-use-authorizations#covid19ivd   …
FDA issued an emergency use authorization (EUA) that authorizes eligible molecular-based laboratory developed tests, or LDTs, that are developed and used by a single CLIA high complexity laboratory. https://www.fda.gov/medical-devices/emergency-situations-medical-devices/emergency-use-authorizations#covid19ivd … (Source: Food and Drug Adminstration (FDA): CDRHNew)
Source: Food and Drug Adminstration (FDA): CDRHNew - April 2, 2020 Category: Medical Devices Authors: ( at SteveFDA) Source Type: news

FDA is working full speed in the fight against the #COVID19 pandemic. Here is the latest update on actions we ’ ve taken: https://www.fda.gov/news-events/press-announcements/coronavirus-covid-19-update-daily-roundup-april-1-2020   … pic.twitter.com/8X8YYADl7v
FDA is working full speed in the fight against the #COVID19 pandemic. Here is the latest update on actions we’ve taken: https://www.fda.gov/news-events/press-announcements/coronavirus-covid-19-update-daily-roundup-april-1-2020 … pic.twitter.com/8X8YYADl7v (Source: Food and Drug Adminstration (FDA): CDRHNew)
Source: Food and Drug Adminstration (FDA): CDRHNew - April 2, 2020 Category: Medical Devices Authors: ( at SteveFDA) Source Type: news

Everyone can help prevent spread of #COVID19. Clara, the #Coronavirus Self-Checker, can help you decide when to call your doctor if you are feeling sick. Start using Clara here: https://bit.ly/3demecB   pic.twitter.com/GskABgsdsV
Everyone can help prevent spread of #COVID19. Clara, the #Coronavirus Self-Checker, can help you decide when to call your doctor if you are feeling sick. Start using Clara here: https://bit.ly/3demecB  pic.twitter.com/GskABgsdsV (Source: Food and Drug Adminstration (FDA): CDRHNew)
Source: Food and Drug Adminstration (FDA): CDRHNew - April 2, 2020 Category: Medical Devices Authors: ( at CDCgov) Source Type: news

Correctional and detention facility administrators: Once #COVID19 enters a facility, it can spread quickly. Read guidance on protecting your staff, incarcerated persons, and potential visitors from coronavirus. https://bit.ly/2Jw2jrQ   pic.twitter.com/TYA5nr3zvi
Correctional and detention facility administrators: Once #COVID19 enters a facility, it can spread quickly. Read guidance on protecting your staff, incarcerated persons, and potential visitors from coronavirus. https://bit.ly/2Jw2jrQ  pic.twitter.com/TYA5nr3zvi (Source: Food and Drug Adminstration (FDA): CDRHNew)
Source: Food and Drug Adminstration (FDA): CDRHNew - April 2, 2020 Category: Medical Devices Authors: ( at CDCgov) Source Type: news

FDA is proposing to reclassify certain Hepatitis C (HCV) diagnostic tests from class III to II. Once finalized, tests of this type and use will go through FDA ’ s 510(k) pathway. Learn more: https://go.usa.gov/xvCuw   & https://go.usa.gov/xvCuH   pic.twitter.com/UXLETnMnJj
FDA is proposing to reclassify certain Hepatitis C (HCV) diagnostic tests from class III to II. Once finalized, tests of this type and use will go through FDA’s 510(k) pathway. Learn more: https://go.usa.gov/xvCuw  & https://go.usa.gov/xvCuH  pic.twitter.com/UXLETnMnJj (Source: Food and Drug Adminstration (FDA): CDRHNew)
Source: Food and Drug Adminstration (FDA): CDRHNew - April 2, 2020 Category: Medical Devices Authors: ( at US_FDA) Source Type: news

Find out more about the HCV Antibody Test. https://go.usa.gov/xvCJn  
Find out more about the HCV Antibody Test. https://go.usa.gov/xvCJn  (Source: Food and Drug Adminstration (FDA): CDRHNew)
Source: Food and Drug Adminstration (FDA): CDRHNew - April 1, 2020 Category: Medical Devices Authors: ( at FDADeviceInfo) Source Type: news

This reclassification, if finalized, will streamline the @US_FDA ’ s regulatory review while still ensuring the tests rely on valid scientific evidence to demonstrate analytical and clinical validity. #MedicalDevice
This reclassification, if finalized, will streamline the @US_FDA’s regulatory review while still ensuring the tests rely on valid scientific evidence to demonstrate analytical and clinical validity. #MedicalDevice (Source: Food and Drug Adminstration (FDA): CDRHNew)
Source: Food and Drug Adminstration (FDA): CDRHNew - April 1, 2020 Category: Medical Devices Authors: ( at FDADeviceInfo) Source Type: news

Today, the @US_FDA proposes to reclassify two types of hepatitis C virus (HCV) diagnostic tests from class III to II. If this reclassification is finalized, tests of this type and use may go through the FDA ’ s 510(k) pathway for clearance.
Today, the @US_FDA proposes to reclassify two types of hepatitis C virus (HCV) diagnostic tests from class III to II. If this reclassification is finalized, tests of this type and use may go through the FDA’s 510(k) pathway for clearance. (Source: Food and Drug Adminstration (FDA): CDRHNew)
Source: Food and Drug Adminstration (FDA): CDRHNew - April 1, 2020 Category: Medical Devices Authors: ( at FDADeviceInfo) Source Type: news

Find out more about the HCV RNA Test. https://go.usa.gov/xvCJ8  
Find out more about the HCV RNA Test. https://go.usa.gov/xvCJ8  (Source: Food and Drug Adminstration (FDA): CDRHNew)
Source: Food and Drug Adminstration (FDA): CDRHNew - April 1, 2020 Category: Medical Devices Authors: ( at FDADeviceInfo) Source Type: news

FDA issued an emergency use authorization (EUA) that authorizes eligible molecular-based laboratory developed tests, or LDTs, that are developed and used by a single CLIA high complexity laboratory. https://www.fda.gov/medical-devices/emergency-situations-medical-devices/emergency-use-authorizations#covid19ivd   … pic.twitter.com/8iKp4LNHQv
FDA issued an emergency use authorization (EUA) that authorizes eligible molecular-based laboratory developed tests, or LDTs, that are developed and used by a single CLIA high complexity laboratory. https://www.fda.gov/medical-devices/emergency-situations-medical-devices/emergency-use-authorizations#covid19ivd … pic.twitter.com/8iKp4LNHQv (Source: Food and Drug Adminstration (FDA): CDRHNew)
Source: Food and Drug Adminstration (FDA): CDRHNew - April 1, 2020 Category: Medical Devices Authors: ( at SteveFDA) Source Type: news

Learn why some #handsanitizers may not have an expiration date and whether they are still effective after the expiration date by visiting our frequently asked questions about hand sanitizers website: https://go.usa.gov/xvqpe   pic.twitter.com/JUgWnqVgWi
Learn why some #handsanitizers may not have an expiration date and whether they are still effective after the expiration date by visiting our frequently asked questions about hand sanitizers website: https://go.usa.gov/xvqpe  pic.twitter.com/JUgWnqVgWi (Source: Food and Drug Adminstration (FDA): CDRHNew)
Source: Food and Drug Adminstration (FDA): CDRHNew - April 1, 2020 Category: Medical Devices Authors: ( at FDA_Drug_Info) Source Type: news

FDA is using every tool at its disposal to combat the #COVID19 pandemic. Here are the latest actions we ’ ve taken: https://www.fda.gov/news-events/press-announcements/coronavirus-covid-19-update-daily-roundup-march-31-2020   … pic.twitter.com/2kfilfSsIO
FDA is using every tool at its disposal to combat the #COVID19 pandemic. Here are the latest actions we’ve taken: https://www.fda.gov/news-events/press-announcements/coronavirus-covid-19-update-daily-roundup-march-31-2020 … pic.twitter.com/2kfilfSsIO (Source: Food and Drug Adminstration (FDA): CDRHNew)
Source: Food and Drug Adminstration (FDA): CDRHNew - April 1, 2020 Category: Medical Devices Authors: ( at SteveFDA) Source Type: news

REMINDER: Flagging for developers of tests for SARS-CoV-2: Virtual Town Hall Series - Immediately in Effect Guidance on Coronavirus (COVID-19) Diagnostic Tests. Wednesday April 1, 2020 12:15-1:15 ET https://twitter.com/FDADeviceInfo/status/1243623373084778497   …
REMINDER: Flagging for developers of tests for SARS-CoV-2: Virtual Town Hall Series - Immediately in Effect Guidance on Coronavirus (COVID-19) Diagnostic Tests. Wednesday April 1, 2020 12:15-1:15 ET https://twitter.com/FDADeviceInfo/status/1243623373084778497 … (Source: Food and Drug Adminstration (FDA): CDRHNew)
Source: Food and Drug Adminstration (FDA): CDRHNew - March 31, 2020 Category: Medical Devices Authors: ( at FDADeviceInfo) Source Type: news

Check out @US_FDA's new Coronavirus Treatment Acceleration Program (#CTAP). It uses every available method to move new treatments to #patients as quickly as possible, while at the same time finding out whether they are helpful or harmful. #FlattenTheCurve https://www.fda.gov/drugs/coronavirus-covid-19-drugs/coronavirus-treatment-acceleration-program-ctap   …
Check out @US_FDA's new Coronavirus Treatment Acceleration Program ( #CTAP). It uses every available method to move new treatments to #patients as quickly as possible, while at the same time finding out whether they are helpful or harmful. #FlattenTheCurve https://www.fda.gov/drugs/coronavirus-covid-19-drugs/coronavirus-treatment-acceleration-program-ctap … (Source: Food and Drug Adminstration (FDA): CDRHNew)
Source: Food and Drug Adminstration (FDA): CDRHNew - March 31, 2020 Category: Medical Devices Authors: ( at AnandShahFDA) Source Type: news

Another company we warned, Bioactive C60/FullerLifeC60 LLC, sells an unapproved and unauthorized product, “ FullerLifeC60, ” with misleading claims it can build up your immunity to help mitigate, prevent, treat, diagnose, or cure #COVID19 in people. https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/bioactive-c60fullerlifec60-llc-605954-03302020   …
Another company we warned, Bioactive C60/FullerLifeC60 LLC, sells an unapproved and unauthorized product, “FullerLifeC60,” with misleading claims it can build up your immunity to help mitigate, prevent, treat, diagnose, or cure #COVID19 in people. https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/bioactive-c60fullerlifec60-llc-605954-03302020 … (Source: Food and Drug Adminstration (FDA): CDRHNew)
Source: Food and Drug Adminstration (FDA): CDRHNew - March 31, 2020 Category: Medical Devices Authors: ( at SteveFDA) Source Type: news

Today, FDA and @FTC issued warning letters to 3 companies for selling fraudulent products with claims to prevent, treat, mitigate, diagnose or cure #COVID19. https://www.fda.gov/consumers/health-fraud-scams/fraudulent-coronavirus-disease-2019-covid-19-products   … pic.twitter.com/IoyCudkXmX
Today, FDA and @FTC issued warning letters to 3 companies for selling fraudulent products with claims to prevent, treat, mitigate, diagnose or cure #COVID19. https://www.fda.gov/consumers/health-fraud-scams/fraudulent-coronavirus-disease-2019-covid-19-products … pic.twitter.com/IoyCudkXmX (Source: Food and Drug Adminstration (FDA): CDRHNew)
Source: Food and Drug Adminstration (FDA): CDRHNew - March 31, 2020 Category: Medical Devices Authors: ( at SteveFDA) Source Type: news

During this time, children may be home from school and you may have more #handsanitizer accessible. Be sure to keep all hand sanitizer products out of reach of children, and call poison control if swallowed at 800-222-1222 or go to http://poison.org   .pic.twitter.com/9eu2b0FagZ
During this time, children may be home from school and you may have more #handsanitizer accessible. Be sure to keep all hand sanitizer products out of reach of children, and call poison control if swallowed at 800-222-1222 or go to http://poison.org . pic.twitter.com/9eu2b0FagZ (Source: Food and Drug Adminstration (FDA): CDRHNew)
Source: Food and Drug Adminstration (FDA): CDRHNew - March 31, 2020 Category: Medical Devices Authors: ( at FDA_Drug_Info) Source Type: news

FDA is actively and aggressively monitoring for any firms marketing products with fraudulent #COVID19 diagnostic, prevention and treatment claims as part of our ongoing efforts to protect public health during this pandemic. https://twitter.com/FDA_ORA/status/1244974853796528128   …
FDA is actively and aggressively monitoring for any firms marketing products with fraudulent #COVID19 diagnostic, prevention and treatment claims as part of our ongoing efforts to protect public health during this pandemic. https://twitter.com/FDA_ORA/status/1244974853796528128 … (Source: Food and Drug Adminstration (FDA): CDRHNew)
Source: Food and Drug Adminstration (FDA): CDRHNew - March 31, 2020 Category: Medical Devices Authors: ( at US_FDA) Source Type: news

I am proud to lead @US_FDA, which plays an indispensable role in the American health care system and in our country's response to the #coronavirus pandemic. I encourage you to read about what FDA is doing to fight #COVID19. https://www.cnn.com/2020/03/30/opinions/fda-coronavirus-vaccine-testing-hahn/index.html   …
I am proud to lead @US_FDA, which plays an indispensable role in the American health care system and in our country's response to the #coronavirus pandemic. I encourage you to read about what FDA is doing to fight #COVID19. https://www.cnn.com/2020/03/30/opinions/fda-coronavirus-vaccine-testing-hahn/index.html … (Source: Food and Drug Adminstration (FDA): CDRHNew)
Source: Food and Drug Adminstration (FDA): CDRHNew - March 31, 2020 Category: Medical Devices Authors: ( at SteveFDA) Source Type: news

We ’ ve just updated our FAQs for diagnostic testing of #COVID19 to include more information about tests for use at the point of care and validating your test by bridging: https://go.usa.gov/xvaj6   pic.twitter.com/i32ajL9uPT
We’ve just updated our FAQs for diagnostic testing of #COVID19 to include more information about tests for use at the point of care and validating your test by bridging: https://go.usa.gov/xvaj6  pic.twitter.com/i32ajL9uPT (Source: Food and Drug Adminstration (FDA): CDRHNew)
Source: Food and Drug Adminstration (FDA): CDRHNew - March 31, 2020 Category: Medical Devices Authors: ( at FDADeviceInfo) Source Type: news

FDA is working 24/7 to respond to the #COVID19 pandemic. Here are latest actions we ’ ve taken: https://www.fda.gov/news-events/press-announcements/coronavirus-covid-19-update-daily-roundup-march-30-2020   … pic.twitter.com/8TdLdMwB5L
FDA is working 24/7 to respond to the #COVID19 pandemic. Here are latest actions we’ve taken: https://www.fda.gov/news-events/press-announcements/coronavirus-covid-19-update-daily-roundup-march-30-2020 … pic.twitter.com/8TdLdMwB5L (Source: Food and Drug Adminstration (FDA): CDRHNew)
Source: Food and Drug Adminstration (FDA): CDRHNew - March 31, 2020 Category: Medical Devices Authors: ( at SteveFDA) Source Type: news

The devices ’ delivery system could fracture while placing the stent inside the patient. Find out more about this #MedicalDevice recall. https://go.usa.gov/xvaxZ  
The devices’ delivery system could fracture while placing the stent inside the patient. Find out more about this #MedicalDevice recall. https://go.usa.gov/xvaxZ  (Source: Food and Drug Adminstration (FDA): CDRHNew)
Source: Food and Drug Adminstration (FDA): CDRHNew - March 30, 2020 Category: Medical Devices Authors: ( at FDADeviceInfo) Source Type: news

Today, the @US_FDA identified a Class I Recall, the most serious type of recall: Medtronic Recalls Pipeline Flex Embolization Devices Due to Risk of Device Fracture.pic.twitter.com/Z271monZK1
Today, the @US_FDA identified a Class I Recall, the most serious type of recall: Medtronic Recalls Pipeline Flex Embolization Devices Due to Risk of Device Fracture. pic.twitter.com/Z271monZK1 (Source: Food and Drug Adminstration (FDA): CDRHNew)
Source: Food and Drug Adminstration (FDA): CDRHNew - March 30, 2020 Category: Medical Devices Authors: ( at FDADeviceInfo) Source Type: news