Food and Drug Adminstration (FDA): CDRHNew This is an RSS file. You can use it to subscribe to this data in your favourite RSS reader or to display this data on your own website or blog.
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