Last month, FDA issued a policy providing regulatory flexibility in certain circumstances for validated serological tests performed in laboratories and patient care settings. https://www.fda.gov/news-events/press-announcements/coronavirus-covid-19-update-fda-provides-more-regulatory-relief-during-outbreak-continues-help   …
Last month, FDA issued a policy providing regulatory flexibility in certain circumstances for validated serological tests performed in laboratories and patient care settings. 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 - April 18, 2020 Category: Medical Devices Authors: ( at SteveFDA) Source Type: news

Some serological test developers have falsely claimed their tests are FDA authorized or that their tests can diagnose #COVID19. When we become aware of this, we take appropriate action against firms making or distributing unvalidated tests or making false claims.
(Source: Food and Drug Adminstration (FDA): CDRHNew)
Source: Food and Drug Adminstration (FDA): CDRHNew - April 18, 2020 Category: Medical Devices Authors: ( at SteveFDA) Source Type: news

As #COVID19 mitigation efforts continue to #FlattenTheCurve, many Americans are wondering when they can resume normal activities. Antibody tests — or serological tests — could play a role in this complex calculation. https://www.fda.gov/news-events/press-announcements/coronavirus-covid-19-update-serological-test-validation-and-education-efforts   … pic.twitter.com/qHao5l2Tzs
As #COVID19 mitigation efforts continue to #FlattenTheCurve, many Americans are wondering when they can resume normal activities. Antibody tests—or serological tests—could play a role in this complex calculation. https://www.fda.gov/news-events/press-announcements/coronavirus-covid-19-update-serological-test-validation-and-education-efforts … pic.twitter.com/qHao5l2Tzs (Source: Food and Drug Adminstration (FDA): CDRHNew)
Source: Food and Drug Adminstration (FDA): CDRHNew - April 18, 2020 Category: Medical Devices Authors: ( at SteveFDA) Source Type: news

To continue to expand #COVID19 testing capability, @US_FDA has updated information on its website regarding swabs used to collect patient samples for #COVID19 testing to include spun synthetic nasal swabs. https://www.fda.gov/news-events/press-announcements/coronavirus-covid-19-update-fda-gates-foundation-unitedhealth-group-quantigen-and-us-cotton   … pic.twitter.com/oNoJGcOopB
To continue to expand #COVID19 testing capability, @US_FDA has updated information on its website regarding swabs used to collect patient samples for #COVID19 testing to include spun synthetic nasal swabs. https://www.fda.gov/news-events/press-announcements/coronavirus-covid-19-update-fda-gates-foundation-unitedhealth-group-quantigen-and-us-cotton … pic.twitter.com/oNoJGcOopB (Source: Food and Drug Adminstration (FDA): CDRHNew)
Source: Food and Drug Adminstration (FDA): CDRHNew - April 18, 2020 Category: Medical Devices Authors: ( at SteveFDA) Source Type: news

FDA encourages health care professionals and consumers to report adverse events or quality problems experienced with the use of #COVID19 products to the FDA ’ s MedWatch Adverse Event Reporting program. https://www.fda.gov/safety/medwatch-fda-safety-information-and-adverse-event-reporting-program   …
FDA encourages health care professionals and consumers to report adverse events or quality problems experienced with the use of #COVID19 products to the FDA’s MedWatch Adverse Event Reporting program. https://www.fda.gov/safety/medwatch-fda-safety-information-and-adverse-event-reporting-program … (Source: Food and Drug Adminstration (FDA): CDRHNew)
Source: Food and Drug Adminstration (FDA): CDRHNew - April 17, 2020 Category: Medical Devices Authors: ( at SteveFDA) Source Type: news

Today, a federal court entered a temporary injunction against the Genesis II Church of Health and Healing requiring them to immediately stop distributing “ Miracle Mineral Solution, ” an unproven, potentially harmful product that claims to treat #COVID19 https://www.fda.gov/news-events/press-announcements/coronavirus-covid-19-update-federal-judge-enters-temporary-injunction-against-genesis-ii-church   … pic.twitter.com/8Z5qeaeiZQ
Today, a federal court entered a temporary injunction against the Genesis II Church of Health and Healing requiring them to immediately stop distributing “Miracle Mineral Solution,” an unproven, potentially harmful product that claims to treat #COVID19 https://www.fda.gov/news-events/press-announcements/coronavirus-covid-19-update-federal-judge-enters-temporary-injunction-against-genesis-ii-church … pic.twitter.com/8Z5qeaeiZQ (Source: Food and Drug Adminstration (FDA): CDRHNew)
Source: Food and Drug Adminstration (FDA): CDRHNew - April 17, 2020 Category: Medical Devices Authors: ( at SteveFDA) Source Type: news

Collaboration through the ACTIV partnership is critical for success & FDA will continue to use every tool possible under our #Coronavirus Treatment Acceleration Program to speed the development of safe & effective medical countermeasures. https://twitter.com/NIH/status/1251134603894484997   …
Collaboration through the ACTIV partnership is critical for success & FDA will continue to use every tool possible under our #Coronavirus Treatment Acceleration Program to speed the development of safe & effective medical countermeasures. https://twitter.com/NIH/status/1251134603894484997 … (Source: Food and Drug Adminstration (FDA): CDRHNew)
Source: Food and Drug Adminstration (FDA): CDRHNew - April 17, 2020 Category: Medical Devices Authors: ( at SteveFDA) Source Type: news

As we continue to increase the number of authorized #COVID19 tests, we ’ ve worked with 315+ test developers who have said they will submit EUA requests for diagnostic tests. 190+ labs have begun testing under our Policy for Diagnostic Tests for Coronavirus Disease-2019.
As we continue to increase the number of authorized #COVID19 tests, we’ve worked with 315+ test developers who have said they will submit EUA requests for diagnostic tests. 190+ labs have begun testing under our Policy for Diagnostic Tests for Coronavirus Disease-2019. (Source: Food and Drug Adminstration (FDA): CDRHNew)
Source: Food and Drug Adminstration (FDA): CDRHNew - April 17, 2020 Category: Medical Devices Authors: ( at SteveFDA) Source Type: news

To date, we ’ ve issued 37 emergency use authorizations (EUAs) for #COVID19 diagnostic tests. Most recently, EUAs were issued to Mount Sinai Laboratory ’ s COVID-19 ELISA IgG Antibody Test & Maccura Biotechnology (USA) LLC ’ s SARS-CoV-2 Fluorescent PCR Kit. https://www.fda.gov/medical-devices/emergency-situations-medical-devices/emergency-use-authorizations#covid19ivd   …
To date, we’ve issued 37 emergency use authorizations (EUAs) for #COVID19 diagnostic tests. Most recently, EUAs were issued to Mount Sinai Laboratory’s COVID-19 ELISA IgG Antibody Test & Maccura Biotechnology (USA) LLC’s SARS-CoV-2 Fluorescent PCR Kit. 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 17, 2020 Category: Medical Devices Authors: ( at SteveFDA) Source Type: news

We issued guidance help expand the availability of telethermographic systems used for body temperature measurements for triage use during the #COVID19 public health emergency. https://www.fda.gov/regulatory-information/search-fda-guidance-documents/enforcement-policy-telethermographic-systems-during-coronavirus-disease-2019-covid-19-public-health   …
We issued guidance help expand the availability of telethermographic systems used for body temperature measurements for triage use during the #COVID19 public health emergency. https://www.fda.gov/regulatory-information/search-fda-guidance-documents/enforcement-policy-telethermographic-systems-during-coronavirus-disease-2019-covid-19-public-health … (Source: Food and Drug Adminstration (FDA): CDRHNew)
Source: Food and Drug Adminstration (FDA): CDRHNew - April 17, 2020 Category: Medical Devices Authors: ( at SteveFDA) Source Type: news

We updated the question-and-answer appendix in a guidance on conducting clinical trials of medical products during the #COVID19 pandemic. https://www.fda.gov/regulatory-information/search-fda-guidance-documents/fda-guidance-conduct-clinical-trials-medical-products-during-covid-19-pandemic   …
We updated the question-and-answer appendix in a guidance on conducting clinical trials of medical products during the #COVID19 pandemic. https://www.fda.gov/regulatory-information/search-fda-guidance-documents/fda-guidance-conduct-clinical-trials-medical-products-during-covid-19-pandemic … (Source: Food and Drug Adminstration (FDA): CDRHNew)
Source: Food and Drug Adminstration (FDA): CDRHNew - April 17, 2020 Category: Medical Devices Authors: ( at SteveFDA) Source Type: news

FDA issued a temporary policy for outsourcing facilities to compound certain drugs for hospitalized patients during the #COVID19 pandemic when hospitals aren ’ t able to access FDA-approved drugs. https://www.fda.gov/regulatory-information/search-fda-guidance-documents/temporary-policy-compounding-certain-drugs-hospitalized-patients-outsourcing-facilities-during-covid   …
FDA issued a temporary policy for outsourcing facilities to compound certain drugs for hospitalized patients during the #COVID19 pandemic when hospitals aren’t able to access FDA-approved drugs. https://www.fda.gov/regulatory-information/search-fda-guidance-documents/temporary-policy-compounding-certain-drugs-hospitalized-patients-outsourcing-facilities-during-covid … (Source: Food and Drug Adminstration (FDA): CDRHNew)
Source: Food and Drug Adminstration (FDA): CDRHNew - April 17, 2020 Category: Medical Devices Authors: ( at SteveFDA) Source Type: news

Our top priority during the #COVID19 pandemic is protecting the public health and safety. Here is an update on FDA ’ s latest actions: https://www.fda.gov/news-events/press-announcements/coronavirus-covid-19-update-daily-roundup-april-16-2020   … pic.twitter.com/ezNbJzQL1Z
Our top priority during the #COVID19 pandemic is protecting the public health and safety. Here is an update on FDA’s latest actions: https://www.fda.gov/news-events/press-announcements/coronavirus-covid-19-update-daily-roundup-april-16-2020 … pic.twitter.com/ezNbJzQL1Z (Source: Food and Drug Adminstration (FDA): CDRHNew)
Source: Food and Drug Adminstration (FDA): CDRHNew - April 17, 2020 Category: Medical Devices Authors: ( at SteveFDA) Source Type: news

FDA has heard your concerns about shopping for #food safely. We want to assure you there is currently NO evidence of human or animal food or food packaging being associated with transmission of the #COVID19 . More food shopping info here: https://go.usa.gov/xv86k  
FDA has heard your concerns about shopping for #food safely. We want to assure you there is currently NO evidence of human or animal food or food packaging being associated with transmission of the #COVID19 . More food shopping info here: https://go.usa.gov/xv86k  (Source: Food and Drug Adminstration (FDA): CDRHNew)
Source: Food and Drug Adminstration (FDA): CDRHNew - April 16, 2020 Category: Medical Devices Authors: ( at FDAfood) Source Type: news

FDA is facilitating development of & access to convalescent plasma as potential #COVID19 treatment. If you ’ ve recovered from COVID-19 for at least 28 days OR have no symptoms for at least 14 days & a negative COVID-19 lab test, consider donating plasma https://www.fda.gov/news-events/press-announcements/coronavirus-covid-19-update-fda-encourages-recovered-patients-donate-plasma-development-blood   … pic.twitter.com/jEwXv1COpC
FDA is facilitating development of & access to convalescent plasma as potential #COVID19 treatment. If you’ve recovered from COVID-19 for at least 28 days OR have no symptoms for at least 14 days & a negative COVID-19 lab test, consider donating plasma https://www.fda.gov/news-events/press-announcements/coronavirus-covid-19-update-fda-encourages-recovered-patients-donate-plasma-development-blood … pic.twitter.com/jEwXv1COpC (Source: Food and Drug Adminstration (FDA): CDRHNew)
Source: Food and Drug Adminstration (FDA): CDRHNew - April 16, 2020 Category: Medical Devices Authors: ( at US_FDA) Source Type: news