Play it safe to protect yourself and others from #COVID19 by following these guidelines for staying connected while social distancing. https://bit.ly/2QAPMaG   #PhysicalDistancepic.twitter.com/NQV5gF5yKy
Play it safe to protect yourself and others from #COVID19 by following these guidelines for staying connected while social distancing. https://bit.ly/2QAPMaG  #PhysicalDistance pic.twitter.com/NQV5gF5yKy (Source: Food and Drug Adminstration (FDA): CDRHNew)
Source: Food and Drug Adminstration (FDA): CDRHNew - March 30, 2020 Category: Medical Devices Authors: ( at HHS_ASH) Source Type: news

The infusion pumps deliver fluids and medications. The affected infusion pumps and infusion pump systems lead to over- and under-infusion in patients. Find out more about this #MedicalDevice recall. https://go.usa.gov/xvxFz  
The infusion pumps deliver fluids and medications. The affected infusion pumps and infusion pump systems lead to over- and under-infusion in patients. Find out more about this #MedicalDevice recall. https://go.usa.gov/xvxFz  (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: CME America Recalls CME America BodyGuard Infusion Pump System Due to Risk of Over- and Under-Infusionpic.twitter.com/YyHeC3URXT
Today, the @US_FDA identified a Class I Recall, the most serious type of recall: CME America Recalls CME America BodyGuard Infusion Pump System Due to Risk of Over- and Under-Infusion pic.twitter.com/YyHeC3URXT (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

The deadline for our public comment period has been extended to May 1! Provide feedback on our white paper on " Maximizing Patient Input in the Design and Development of Medical Device Clinical Trials " . Learn more and submit comments here: http://bit.ly/2VMuoT0   pic.twitter.com/RXzfMLzhli
The deadline for our public comment period has been extended to May 1! Provide feedback on our white paper on "Maximizing Patient Input in the Design and Development of Medical Device Clinical Trials". Learn more and submit comments here: http://bit.ly/2VMuoT0  pic.twitter.com/RXzfMLzhli (Source: Food and Drug Adminstration (FDA): CDRHNew)
Source: Food and Drug Adminstration (FDA): CDRHNew - March 30, 2020 Category: Medical Devices Authors: ( at MDIConline) Source Type: news

Later today FDA will release an enforcement policy for gowns, other apparel, and gloves to help expand the availability of surgical apparel for health care professionals during this pandemic.
(Source: Food and Drug Adminstration (FDA): CDRHNew)
Source: Food and Drug Adminstration (FDA): CDRHNew - March 30, 2020 Category: Medical Devices Authors: ( at SteveFDA) Source Type: news

Do not use disinfectant sprays or wipes on your skin because they may cause skin and eye irritation. They are intended for use on hard, non-porous surfaces. https://go.usa.gov/xvqpe   pic.twitter.com/yzpP7K4R0q
Do not use disinfectant sprays or wipes on your skin because they may cause skin and eye irritation. They are intended for use on hard, non-porous surfaces. https://go.usa.gov/xvqpe  pic.twitter.com/yzpP7K4R0q (Source: Food and Drug Adminstration (FDA): CDRHNew)
Source: Food and Drug Adminstration (FDA): CDRHNew - March 30, 2020 Category: Medical Devices Authors: ( at FDA_Drug_Info) Source Type: news

This #NationalDoctorsDay we want to express our immense gratitude to everyone working in the healthcare arena. You are superheroes.pic.twitter.com/8zvcy7xdpB
This #NationalDoctorsDay we want to express our immense gratitude to everyone working in the healthcare arena. You are superheroes. pic.twitter.com/8zvcy7xdpB (Source: Food and Drug Adminstration (FDA): CDRHNew)
Source: Food and Drug Adminstration (FDA): CDRHNew - March 30, 2020 Category: Medical Devices Authors: ( at US_FDA) Source Type: news

FDA issued an Emergency Use Authorization (EUA) to @Battelle for its Battelle CCDS Critical Care Decontamination System for use in decontaminating compatible single-use N95 respirators so they can be reused by health care personnel during #COVID19. https://www.fda.gov/medical-devices/emergency-situations-medical-devices/emergency-use-authorizations#coronavirus2019   … pic.twitter.com/fWwmrtM1fS
FDA issued an Emergency Use Authorization (EUA) to @Battelle for its Battelle CCDS Critical Care Decontamination System for use in decontaminating compatible single-use N95 respirators so they can be reused by health care personnel during #COVID19. https://www.fda.gov/medical-devices/emergency-situations-medical-devices/emergency-use-authorizations#coronavirus2019 … pic.twitter.com/fWwmrtM1fS (Source: Food and Drug Adminstration (FDA): CDRHNew)
Source: Food and Drug Adminstration (FDA): CDRHNew - March 29, 2020 Category: Medical Devices Authors: ( at SteveFDA) Source Type: news

(1/5) Today ’ s #SundaySpotlight breaks through some of the misinformation and rumors about #COVID19! Here are the facts about how #coronavirus spreads.pic.twitter.com/D2poNF3cLv
(1/5) Today’s #SundaySpotlight breaks through some of the misinformation and rumors about #COVID19! Here are the facts about how #coronavirus spreads. pic.twitter.com/D2poNF3cLv (Source: Food and Drug Adminstration (FDA): CDRHNew)
Source: Food and Drug Adminstration (FDA): CDRHNew - March 29, 2020 Category: Medical Devices Authors: ( at Surgeon_General) Source Type: news

Flagging for developers of tests for SARS-CoV-2. We will be hosting our 2nd virtual Town Hall on April 1st from 12:15-1:15 PM ET to answer technical questions about the development and validation of tests for SARS-CoV-2 and the recently issued guidance. https://go.usa.gov/xv3hx   pic.twitter.com/JFWWIhRJxt
Flagging for developers of tests for SARS-CoV-2. We will be hosting our 2nd virtual Town Hall on April 1st from 12:15-1:15 PM ET to answer technical questions about the development and validation of tests for SARS-CoV-2 and the recently issued guidance. https://go.usa.gov/xv3hx  pic.twitter.com/JFWWIhRJxt (Source: Food and Drug Adminstration (FDA): CDRHNew)
Source: Food and Drug Adminstration (FDA): CDRHNew - March 27, 2020 Category: Medical Devices Authors: ( at FDADeviceInfo) Source Type: news

FDA recently issued an emergency use authorization to help increase the U.S. supply of ventilators to ease burdens on the health care system and provide critically ill patients with lifesaving devices. https://www.fda.gov/news-events/press-announcements/coronavirus-covid-19-update-fda-takes-action-help-increase-us-supply-ventilators-and-respirators   … pic.twitter.com/AnHW2ShVCt
FDA recently issued an emergency use authorization to help increase the U.S. supply of ventilators to ease burdens on the health care system and provide critically ill patients with lifesaving devices. https://www.fda.gov/news-events/press-announcements/coronavirus-covid-19-update-fda-takes-action-help-increase-us-supply-ventilators-and-respirators … pic.twitter.com/AnHW2ShVCt (Source: Food and Drug Adminstration (FDA): CDRHNew)
Source: Food and Drug Adminstration (FDA): CDRHNew - March 27, 2020 Category: Medical Devices Authors: ( at US_FDA) Source Type: news

FDA took action to help increase the U.S. supply of ventilators and respirators as part of our commitment to ease burdens on the health care system during the #COVID19 public health emergency. https://www.fda.gov/news-events/press-announcements/coronavirus-covid-19-update-fda-takes-action-help-increase-us-supply-ventilators-and-respirators   … pic.twitter.com/FeCHowXveX
FDA took action to help increase the U.S. supply of ventilators and respirators as part of our commitment to ease burdens on the health care system during the #COVID19 public health emergency. https://www.fda.gov/news-events/press-announcements/coronavirus-covid-19-update-fda-takes-action-help-increase-us-supply-ventilators-and-respirators … pic.twitter.com/FeCHowXveX (Source: Food and Drug Adminstration (FDA): CDRHNew)
Source: Food and Drug Adminstration (FDA): CDRHNew - March 27, 2020 Category: Medical Devices Authors: ( at SteveFDA) Source Type: news

Today, the @US_FDA made a minor update to the Final Guidance on the Center for Devices and Radiological Health (CDRH) Appeals Processes: Questions and Answers About 517A.
(Source: Food and Drug Adminstration (FDA): CDRHNew)
Source: Food and Drug Adminstration (FDA): CDRHNew - March 27, 2020 Category: Medical Devices Authors: ( at FDADeviceInfo) Source Type: news

The guidance clarifies how a request for a “ substantive summary ” should be submitted to the Agency. Find out more about this final guidance. https://go.usa.gov/xv3JF  
The guidance clarifies how a request for a “substantive summary” should be submitted to the Agency. Find out more about this final guidance. https://go.usa.gov/xv3JF  (Source: Food and Drug Adminstration (FDA): CDRHNew)
Source: Food and Drug Adminstration (FDA): CDRHNew - March 27, 2020 Category: Medical Devices Authors: ( at FDADeviceInfo) Source Type: news

The U.S. food supply remains safe for both people and animals. Despite the #COVID19 pandemic, there are currently no nationwide shortages of food, but there are localized reports of shortages. Read more about food safety and availability in the U.S. https://www.fda.gov/consumers/consumer-updates/food-safety-and-availability-during-coronavirus-pandemic   …
The U.S. food supply remains safe for both people and animals. Despite the #COVID19 pandemic, there are currently no nationwide shortages of food, but there are localized reports of shortages. Read more about food safety and availability in the U.S. https://www.fda.gov/consumers/consumer-updates/food-safety-and-availability-during-coronavirus-pandemic … (Source: Food and Drug Adminstration (FDA): CDRHNew)
Source: Food and Drug Adminstration (FDA): CDRHNew - March 27, 2020 Category: Medical Devices Authors: ( at US_FDA) Source Type: news

In times of national emergency, like the #COVID19 pandemic, unscrupulous actors may try to prey on the public ’ s fear by selling bogus products that claim to deliver cures. @US_FDA is taking action. Please, don ’ t fall prey to health fraud. https://go.usa.gov/xdJxQ  
In times of national emergency, like the #COVID19 pandemic, unscrupulous actors may try to prey on the public’s fear by selling bogus products that claim to deliver cures. @US_FDA is taking action. Please, don’t fall prey to health fraud. https://go.usa.gov/xdJxQ  (Source: Food and Drug Adminstration (FDA): CDRHNew)
Source: Food and Drug Adminstration (FDA): CDRHNew - March 27, 2020 Category: Medical Devices Authors: ( at US_FDA) Source Type: news

Wash your hands, people! Wet, lather, scrub for 20 secs (check out my song, better than Happy Bday), rinse & dry. Great challenge @Surgeon_General to stop #COVID19. I nominate @CDCDirector, @BillGates, & @FDACommissioner for the #SafeHands challenge. #coronaviruspic.twitter.com/xechXUqoqC
Wash your hands, people! Wet, lather, scrub for 20 secs (check out my song, better than Happy Bday), rinse & dry. Great challenge @Surgeon_General to stop #COVID19. I nominate @CDCDirector, @BillGates, & @FDACommissioner for the #SafeHands challenge. #coronavirus pic.twitter.com/xechXUqoqC (Source: Food and Drug Adminstration (FDA): CDRHNew)
Source: Food and Drug Adminstration (FDA): CDRHNew - March 27, 2020 Category: Medical Devices Authors: ( at NIHDirector) Source Type: news

While at home, find creative ways to stay active - get your family and friends involved by starting a push-up challenge or seeing who can do the most squats. #COVID19pic.twitter.com/B8IVsD9vop
While at home, find creative ways to stay active - get your family and friends involved by starting a push-up challenge or seeing who can do the most squats. #COVID19 pic.twitter.com/B8IVsD9vop (Source: Food and Drug Adminstration (FDA): CDRHNew)
Source: Food and Drug Adminstration (FDA): CDRHNew - March 27, 2020 Category: Medical Devices Authors: ( at Surgeon_General) Source Type: news

Here ’ s the latest on what FDA is doing to respond to the #COVID19 public health emergency: https://www.fda.gov/news-events/press-announcements/coronavirus-covid-19-update-daily-roundup-march-26-2020   … pic.twitter.com/B1GOrq2Qdu
Here’s the latest on what FDA is doing to respond to the #COVID19 public health emergency: https://www.fda.gov/news-events/press-announcements/coronavirus-covid-19-update-daily-roundup-march-26-2020 … pic.twitter.com/B1GOrq2Qdu (Source: Food and Drug Adminstration (FDA): CDRHNew)
Source: Food and Drug Adminstration (FDA): CDRHNew - March 27, 2020 Category: Medical Devices Authors: ( at SteveFDA) Source Type: news

To help increase ventilator access, FDA issued an emergency use authorization for certain ventilators, anesthesia gas machines modified for use as ventilators, positive pressure breathing devices modified for use as ventilators, & ventilator accessories. https://www.fda.gov/media/136423/download   …
To help increase ventilator access, FDA issued an emergency use authorization for certain ventilators, anesthesia gas machines modified for use as ventilators, positive pressure breathing devices modified for use as ventilators, & ventilator accessories. https://www.fda.gov/media/136423/download … (Source: Food and Drug Adminstration (FDA): CDRHNew)
Source: Food and Drug Adminstration (FDA): CDRHNew - March 26, 2020 Category: Medical Devices Authors: ( at SteveFDA) Source Type: news

FDA has worked with over 190 #COVID19 test developers who intend to submit EUA applications. To date, 17 emergency use authorizations have been issued & under our laboratory developed test policy, more than 100 labs have notified FDA that they are testing. https://www.fda.gov/medical-devices/emergency-situations-medical-devices/faqs-diagnostic-testing-sars-cov-2   …
FDA has worked with over 190 #COVID19 test developers who intend to submit EUA applications. To date, 17 emergency use authorizations have been issued & under our laboratory developed test policy, more than 100 labs have notified FDA that they are testing. 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 26, 2020 Category: Medical Devices Authors: ( at SteveFDA) Source Type: news

Yesterday, we announced a number of actions FDA has taken to fight the #COVID19 pandemic: https://www.fda.gov/news-events/press-announcements/coronavirus-covid-19-update-daily-roundup-march-25-2020   … pic.twitter.com/xUJEmME0jw
Yesterday, we announced a number of actions FDA has taken to fight the #COVID19 pandemic: https://www.fda.gov/news-events/press-announcements/coronavirus-covid-19-update-daily-roundup-march-25-2020 … pic.twitter.com/xUJEmME0jw (Source: Food and Drug Adminstration (FDA): CDRHNew)
Source: Food and Drug Adminstration (FDA): CDRHNew - March 26, 2020 Category: Medical Devices Authors: ( at SteveFDA) Source Type: news

You have my commitment that I will not rest in the search for possible #COVID19 treatment options. However, our decision-making will always be based on data and science.
(Source: Food and Drug Adminstration (FDA): CDRHNew)
Source: Food and Drug Adminstration (FDA): CDRHNew - March 26, 2020 Category: Medical Devices Authors: ( at SteveFDA) Source Type: news

Every day, over 17,000 @US_FDA professionals are committed to working around the clock to break down barriers to innovation and accelerate the development of lifesaving treatments as part of an all-of-government and all-of-America approach to defeating #COVID19.
(Source: Food and Drug Adminstration (FDA): CDRHNew)
Source: Food and Drug Adminstration (FDA): CDRHNew - March 26, 2020 Category: Medical Devices Authors: ( at SteveFDA) Source Type: news

Find the latest information and answers to frequently asked questions about hand sanitizers and #COVID19 on our website: https://go.usa.gov/xvqpe   .pic.twitter.com/LabgeYD3YM
Find the latest information and answers to frequently asked questions about hand sanitizers and #COVID19 on our website: https://go.usa.gov/xvqpe . pic.twitter.com/LabgeYD3YM (Source: Food and Drug Adminstration (FDA): CDRHNew)
Source: Food and Drug Adminstration (FDA): CDRHNew - March 26, 2020 Category: Medical Devices Authors: ( at FDA_Drug_Info) Source Type: news

The @US_FDA just issued an immediately in effect guidance on the Enforcement Policy for Face Masks and Respirators During the Coronavirus Disease-2019 (COVID-19) Public Health Emergency. https://go.usa.gov/xvqBd  
The @US_FDA just issued an immediately in effect guidance on the Enforcement Policy for Face Masks and Respirators During the Coronavirus Disease-2019 (COVID-19) Public Health Emergency. https://go.usa.gov/xvqBd  (Source: Food and Drug Adminstration (FDA): CDRHNew)
Source: Food and Drug Adminstration (FDA): CDRHNew - March 26, 2020 Category: Medical Devices Authors: ( at FDADeviceInfo) Source Type: news

We believe the policy set forth in this guidance may help address #COVID19 by helping to expand the availability of general use face masks for the general public & particulate filtering facepiece respirators (including N95 respirators) for healthcare professionals.
We believe the policy set forth in this guidance may help address #COVID19 by helping to expand the availability of general use face masks for the general public & particulate filtering facepiece respirators (including N95 respirators) for healthcare professionals. (Source: Food and Drug Adminstration (FDA): CDRHNew)
Source: Food and Drug Adminstration (FDA): CDRHNew - March 26, 2020 Category: Medical Devices Authors: ( at FDADeviceInfo) Source Type: news

All hands and supplies are on deck in the fight against #COVID19. Today @US_FDA ’ s CDRH sent our supply of gloves, masks, gowns, and N95 respirators from our Office of Science and Engineering Laboratories to the Clinical Center at @NIH.pic.twitter.com/dYiNrpnE1B
All hands and supplies are on deck in the fight against #COVID19. Today @US_FDA’s CDRH sent our supply of gloves, masks, gowns, and N95 respirators from our Office of Science and Engineering Laboratories to the Clinical Center at @NIH. pic.twitter.com/dYiNrpnE1B (Source: Food and Drug Adminstration (FDA): CDRHNew)
Source: Food and Drug Adminstration (FDA): CDRHNew - March 25, 2020 Category: Medical Devices Authors: ( at FDADeviceInfo) Source Type: news

We ’ re in the middle of the @WhiteHouse #Coronavirus Task Force ’ s 15 Days to Slow the Spread. Follow these tips to keep yourself, your family and your community healthy. https://twitter.com/HHSGov/status/1242449847426469889   …
We’re in the middle of the @WhiteHouse #Coronavirus Task Force’s 15 Days to Slow the Spread. Follow these tips to keep yourself, your family and your community healthy. https://twitter.com/HHSGov/status/1242449847426469889 … (Source: Food and Drug Adminstration (FDA): CDRHNew)
Source: Food and Drug Adminstration (FDA): CDRHNew - March 25, 2020 Category: Medical Devices Authors: ( at SteveFDA) Source Type: news

Through the emergency Investigational New Drug (eIND) application process, FDA is facilitating the use of #COVID19 convalescent plasma as an investigational treatment for individual #COVID19 patients with serious or immediately life-threatening #COVID19. https://www.fda.gov/vaccines-blood-biologics/investigational-new-drug-ind-or-device-exemption-ide-process-cber/investigational-covid-19-convalescent-plasma-emergency-inds   …
Through the emergency Investigational New Drug (eIND) application process, FDA is facilitating the use of #COVID19 convalescent plasma as an investigational treatment for individual #COVID19 patients with serious or immediately life-threatening #COVID19. https://www.fda.gov/vaccines-blood-biologics/investigational-new-drug-ind-or-device-exemption-ide-process-cber/investigational-covid-19-convalescent-plasma-emergency-inds … (Source: Food and Drug Adminstration (FDA): CDRHNew)
Source: Food and Drug Adminstration (FDA): CDRHNew - March 24, 2020 Category: Medical Devices Authors: ( at US_FDA) Source Type: news

Sometimes science moves faster than the regulatory process, & in times of public health emergency like the #COVID19 pandemic, it is paramount that we be flexible in getting potentially life-saving investigational medicines to patients who need them most. https://www.fda.gov/vaccines-blood-biologics/investigational-new-drug-ind-or-device-exemption-ide-process-cber/investigational-covid-19-convalescent-plasma-emergency-inds   …
Sometimes science moves faster than the regulatory process, & in times of public health emergency like the #COVID19 pandemic, it is paramount that we be flexible in getting potentially life-saving investigational medicines to patients who need them most. https://www.fda.gov/vaccines-blood-biologics/investigational-new-drug-ind-or-device-exemption-ide-process-cber/investigational-covid-19-convalescent-plasma-emergency-inds … (Source: Food and Drug Adminstration (FDA): CDRHNew)
Source: Food and Drug Adminstration (FDA): CDRHNew - March 24, 2020 Category: Medical Devices Authors: ( at SteveFDA) Source Type: news

Parents: A key to slowing the spread of #COVID19 is to limit social interactions and practice #socialdistancing. Press pause on play dates & keep any groups as small as possible. #StayAtHome https://bit.ly/2y0L4fG   pic.twitter.com/g8RJ8Nw4Bs
Parents: A key to slowing the spread of #COVID19 is to limit social interactions and practice #socialdistancing. Press pause on play dates & keep any groups as small as possible. #StayAtHome https://bit.ly/2y0L4fG  pic.twitter.com/g8RJ8Nw4Bs (Source: Food and Drug Adminstration (FDA): CDRHNew)
Source: Food and Drug Adminstration (FDA): CDRHNew - March 24, 2020 Category: Medical Devices Authors: ( at CDCgov) Source Type: news

One of FDA ’ s top priorities in combating the #COVID19 pandemic is facilitating access to critical personal protective equipment (PPE) and devices. Today, we took action to increase the supply of PPE & provided instructions to manufacturers that import it. https://www.fda.gov/news-events/press-announcements/coronavirus-covid-19-update-fda-takes-action-increase-us-supplies-through-instructions-ppe-and   … pic.twitter.com/BYUtJJq3kw
One of FDA’s top priorities in combating the #COVID19 pandemic is facilitating access to critical personal protective equipment (PPE) and devices. Today, we took action to increase the supply of PPE & provided instructions to manufacturers that import it. https://www.fda.gov/news-events/press-announcements/coronavirus-covid-19-update-fda-takes-action-increase-us-supplies-through-instructions-ppe-and … pic.twitter.com/BYUtJJq3kw (Source: Food and Drug Adminstration (FDA): CDRHNew)
Source: Food and Drug Adminstration (FDA): CDRHNew - March 24, 2020 Category: Medical Devices Authors: ( at SteveFDA) Source Type: news

If your pet needs medical attention during the #COVID19 pandemic, & you are social distancing, FDA intends to temporarily suspend certain regulations that may make it easier for a vet to help you from the comfort of your own home. https://www.fda.gov/news-events/press-announcements/coronavirus-covid-19-update-fda-helps-facilitate-veterinary-telemedicine-during-pandemic   … pic.twitter.com/LfZJRYhxyv
If your pet needs medical attention during the #COVID19 pandemic, & you are social distancing, FDA intends to temporarily suspend certain regulations that may make it easier for a vet to help you from the comfort of your own home. https://www.fda.gov/news-events/press-announcements/coronavirus-covid-19-update-fda-helps-facilitate-veterinary-telemedicine-during-pandemic … pic.twitter.com/LfZJRYhxyv (Source: Food and Drug Adminstration (FDA): CDRHNew)
Source: Food and Drug Adminstration (FDA): CDRHNew - March 24, 2020 Category: Medical Devices Authors: ( at US_FDA) Source Type: news

We warned health care providers and patients about the potential risk of #COVID19 transmission through fecal samples for transplantation (FMT) procedures and encouraged anyone suspecting adverse events or side effects to let FDA know. https://www.fda.gov/vaccines-blood-biologics/safety-availability-biologics/safety-alert-regarding-use-fecal-microbiota-transplantation-and-additional-safety-protections   …
We warned health care providers and patients about the potential risk of #COVID19 transmission through fecal samples for transplantation (FMT) procedures and encouraged anyone suspecting adverse events or side effects to let FDA know. https://www.fda.gov/vaccines-blood-biologics/safety-availability-biologics/safety-alert-regarding-use-fecal-microbiota-transplantation-and-additional-safety-protections … (Source: Food and Drug Adminstration (FDA): CDRHNew)
Source: Food and Drug Adminstration (FDA): CDRHNew - March 24, 2020 Category: Medical Devices Authors: ( at SteveFDA) Source Type: news

We ’ re helping to make #COVID19 testing more comfortable for patients, updating specimen collection recommendations regarding the use of nasal swabs at just the front of the nose rather than deep inside the nasal cavity. https://www.fda.gov/medical-devices/emergency-situations-medical-devices/faqs-diagnostic-testing-sars-cov-2   …
We’re helping to make #COVID19 testing more comfortable for patients, updating specimen collection recommendations regarding the use of nasal swabs at just the front of the nose rather than deep inside the nasal cavity. 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 24, 2020 Category: Medical Devices Authors: ( at SteveFDA) Source Type: news

We ’ re working around the clock to support patients, health care professionals, manufacturers and the public during the #COVID19 pandemic. Here ’ s the latest on what we ’ re doing at FDA to combat the #COVID19 pandemic: https://www.fda.gov/news-events/press-announcements/coronavirus-covid-19-update-daily-roundup   … pic.twitter.com/HX6VKDj2IH
We’re working around the clock to support patients, health care professionals, manufacturers and the public during the #COVID19 pandemic. Here’s the latest on what we’re doing at FDA to combat the #COVID19 pandemic: https://www.fda.gov/news-events/press-announcements/coronavirus-covid-19-update-daily-roundup … pic.twitter.com/HX6VKDj2IH (Source: Food and Drug Adminstration (FDA): CDRHNew)
Source: Food and Drug Adminstration (FDA): CDRHNew - March 24, 2020 Category: Medical Devices Authors: ( at SteveFDA) Source Type: news

REMINDER. https://twitter.com/FDADeviceInfo/status/1241079163999719424   …
REMINDER. https://twitter.com/FDADeviceInfo/status/1241079163999719424 … (Source: Food and Drug Adminstration (FDA): CDRHNew)
Source: Food and Drug Adminstration (FDA): CDRHNew - March 24, 2020 Category: Medical Devices Authors: ( at FDADeviceInfo) Source Type: news

We updated our FAQs for diagnostic testing of #COVID19 to include more information about alternative material sources and specimen collection. https://go.usa.gov/xdSps  
We updated our FAQs for diagnostic testing of #COVID19 to include more information about alternative material sources and specimen collection. https://go.usa.gov/xdSps  (Source: Food and Drug Adminstration (FDA): CDRHNew)
Source: Food and Drug Adminstration (FDA): CDRHNew - March 24, 2020 Category: Medical Devices Authors: ( at FDADeviceInfo) Source Type: news

One of FDA ’ s most crucial roles in a public health emergency like the #COVID19 pandemic is to safeguard the health of the American people by monitoring the global supply chain for food and medical products, and taking action to prevent any disruptions. https://www.fda.gov/coronavirus  
One of FDA’s most crucial roles in a public health emergency like the #COVID19 pandemic is to safeguard the health of the American people by monitoring the global supply chain for food and medical products, and taking action to prevent any disruptions. https://www.fda.gov/coronavirus  (Source: Food and Drug Adminstration (FDA): CDRHNew)
Source: Food and Drug Adminstration (FDA): CDRHNew - March 24, 2020 Category: Medical Devices Authors: ( at SteveFDA) Source Type: news

We ’ re working with experts around the world to find ways to prevent and treat #COVID19, including collaborating with international organizations to facilitate the development of a vaccine. For more, read the latest FDA Voices... https://www.fda.gov/news-events/fda-voices-perspectives-fda-leadership-and-experts/fda-and-ema-collaborate-facilitate-sars-cov-2-vaccine-development   …
We’re working with experts around the world to find ways to prevent and treat #COVID19, including collaborating with international organizations to facilitate the development of a vaccine. For more, read the latest FDA Voices... https://www.fda.gov/news-events/fda-voices-perspectives-fda-leadership-and-experts/fda-and-ema-collaborate-facilitate-sars-cov-2-vaccine-development … (Source: Food and Drug Adminstration (FDA): CDRHNew)
Source: Food and Drug Adminstration (FDA): CDRHNew - March 24, 2020 Category: Medical Devices Authors: ( at SteveFDA) Source Type: news

At this time, FDA is not aware of any validated test available to purchase for home testing for #COVID19. http://www.fda.gov/news-events/press-announcements/coronavirus-covid-19-update-fda-alerts-consumers-about-unauthorized-fraudulent-covid-19-test-kits   …
At this time, FDA is not aware of any validated test available to purchase for home testing for #COVID19. http://www.fda.gov/news-events/press-announcements/coronavirus-covid-19-update-fda-alerts-consumers-about-unauthorized-fraudulent-covid-19-test-kits … (Source: Food and Drug Adminstration (FDA): CDRHNew)
Source: Food and Drug Adminstration (FDA): CDRHNew - March 23, 2020 Category: Medical Devices Authors: ( at SteveFDA) Source Type: news

Have you seen this new PSA on TV? Find out how to protect yourself and others at http://Coronavirus.gov   . Together we can help #StoptheSpread of #coronavirus. @CDCgov @AdCouncil #COVID19pic.twitter.com/JxFT04Nrle
Have you seen this new PSA on TV? Find out how to protect yourself and others at http://Coronavirus.gov . Together we can help #StoptheSpread of #coronavirus. @CDCgov @AdCouncil #COVID19 pic.twitter.com/JxFT04Nrle (Source: Food and Drug Adminstration (FDA): CDRHNew)
Source: Food and Drug Adminstration (FDA): CDRHNew - March 23, 2020 Category: Medical Devices Authors: ( at US_FDA) Source Type: news

Know the facts about #COVID19. Don ’ t share rumors & unintentionally spread misinformation. Federal, state & local governments are posting current and accurate information. For help in distinguishing rumor from fact, see @FEMA Coronavirus Rumor Control: https://bit.ly/3ahGFDq   pic.twitter.com/AkbQjOM2xw
Know the facts about #COVID19. Don’t share rumors & unintentionally spread misinformation. Federal, state & local governments are posting current and accurate information. For help in distinguishing rumor from fact, see @FEMA Coronavirus Rumor Control: https://bit.ly/3ahGFDq  pic.twitter.com/AkbQjOM2xw (Source: Food and Drug Adminstration (FDA): CDRHNew)
Source: Food and Drug Adminstration (FDA): CDRHNew - March 23, 2020 Category: Medical Devices Authors: ( at CDCgov) Source Type: news

FDA ’ s updates to our policy on #COVID19 diagnostic testing that was originally issued on Feb. 29 demonstrates FDA ’ s ability to pivot & adapt as the situation warrants in light of a public health emergency: https://www.fda.gov/news-events/press-announcements/coronavirus-covid-19-update-fda-provides-more-regulatory-relief-during-outbreak-continues-help   …
FDA’s updates to our policy on #COVID19 diagnostic testing that was originally issued on Feb. 29 demonstrates FDA’s ability to pivot & adapt as the situation warrants in light of a public health emergency: 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 22, 2020 Category: Medical Devices Authors: ( at SteveFDA) Source Type: news

Recognizing that the need for personal protective equipment (PPE), such as surgical & examination gloves, may outpace the supply available during the #COVID19 pandemic, FDA has published a letter to health care providers sharing conservation strategies. https://www.fda.gov/medical-devices/letters-health-care-providers/medical-glove-conservation-strategies-letter-health-care-providers   … pic.twitter.com/2GsHuDuvHd
Recognizing that the need for personal protective equipment (PPE), such as surgical & examination gloves, may outpace the supply available during the #COVID19 pandemic, FDA has published a letter to health care providers sharing conservation strategies. https://www.fda.gov/medical-devices/letters-health-care-providers/medical-glove-conservation-strategies-letter-health-care-providers … pic.twitter.com/2GsHuDuvHd (Source: Food and Drug Adminstration (FDA): CDRHNew)
Source: Food and Drug Adminstration (FDA): CDRHNew - March 22, 2020 Category: Medical Devices Authors: ( at SteveFDA) Source Type: news

Today we are providing updated information in the FAQs for diagnostic testing of #COVID19 to make clear that, at this time, the FDA has not authorized any test that is available to purchase for testing yourself at home for #COVID19. https://go.usa.gov/xduUx  
Today we are providing updated information in the FAQs for diagnostic testing of #COVID19 to make clear that, at this time, the FDA has not authorized any test that is available to purchase for testing yourself at home for #COVID19. https://go.usa.gov/xduUx  (Source: Food and Drug Adminstration (FDA): CDRHNew)
Source: Food and Drug Adminstration (FDA): CDRHNew - March 21, 2020 Category: Medical Devices Authors: ( at FDADeviceInfo) Source Type: news

The FAQs for diagnostic testing of #COVID19 have also been updated to clarify that, as noted in the guidance, the “ Policy for Diagnostic Tests for Coronavirus Disease-2019 ” does not apply to at-home testing, including self-collection of samples to be sent to a clinical laboratory
The FAQs for diagnostic testing of #COVID19 have also been updated to clarify that, as noted in the guidance, the “Policy for Diagnostic Tests for Coronavirus Disease-2019” does not apply to at-home testing, including self-collection of samples to be sent to a clinical laboratory (Source: Food and Drug Adminstration (FDA): CDRHNew)
Source: Food and Drug Adminstration (FDA): CDRHNew - March 21, 2020 Category: Medical Devices Authors: ( at FDADeviceInfo) Source Type: news

We see the public health value in expanding the availability of #COVID19 testing through safe and accurate tests that may include home collection, and we are actively working with test developers.
(Source: Food and Drug Adminstration (FDA): CDRHNew)
Source: Food and Drug Adminstration (FDA): CDRHNew - March 21, 2020 Category: Medical Devices Authors: ( at FDADeviceInfo) Source Type: news

Everyone has a role to play to reduce & slow transmission of #COVID19. Physical or social distancing is one way to prevent the spread of COVID-19. This means avoiding crowded places and maintaining distance from others. More prevention tips: https://bit.ly/2QbLFkW   . #StayAtHomepic.twitter.com/UMbF3UG7vU
Everyone has a role to play to reduce & slow transmission of #COVID19. Physical or social distancing is one way to prevent the spread of COVID-19. This means avoiding crowded places and maintaining distance from others. More prevention tips: https://bit.ly/2QbLFkW . #StayAtHome pic.twitter.com/UMbF3UG7vU (Source: Food and Drug Adminstration (FDA): CDRHNew)
Source: Food and Drug Adminstration (FDA): CDRHNew - March 21, 2020 Category: Medical Devices Authors: ( at CDCgov) Source Type: news