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 1, 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 1, 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