Medtronic has recalled the auto-registration feature of the StealthStation DBS Software due to inaccuracies caused by minor patient movements during the auto-registration process. Find out more about this #MedicalDevice recall. https://go.usa.gov/xwWCk  
Medtronic has recalled the auto-registration feature of the StealthStation DBS Software due to inaccuracies caused by minor patient movements during the auto-registration process. Find out more about this #MedicalDevice recall. https://go.usa.gov/xwWCk  (Source: Food and Drug Adminstration (FDA): CDRHNew)
Source: Food and Drug Adminstration (FDA): CDRHNew - June 3, 2020 Category: Medical Devices Authors: ( at FDADeviceInfo) Source Type: news

On June 1st, the @US_FDA identified a Class I Recall, the most serious type of recall: Medtronic recalls StealthStation auto-registration feature due to inaccuracies during deep brain stimulation (DBS) procedures.pic.twitter.com/mGsbP4C8be
On June 1st, the @US_FDA identified a Class I Recall, the most serious type of recall: Medtronic recalls StealthStation auto-registration feature due to inaccuracies during deep brain stimulation (DBS) procedures. pic.twitter.com/mGsbP4C8be (Source: Food and Drug Adminstration (FDA): CDRHNew)
Source: Food and Drug Adminstration (FDA): CDRHNew - June 3, 2020 Category: Medical Devices Authors: ( at FDADeviceInfo) Source Type: news

We apologize for today's technical difficulties. A transcript from today's Town Hall will be available by June 9th. We have also confirmed the dial-in information for our next Town Hall call on June 10, 2020 is correct.
(Source: Food and Drug Adminstration (FDA): CDRHNew)
Source: Food and Drug Adminstration (FDA): CDRHNew - June 3, 2020 Category: Medical Devices Authors: ( at FDADeviceInfo) Source Type: news

Emergency department data collected by CDC surveillance networks indicate some patients may be delaying emergency care during the #COVID19 pandemic. Fewer visits for critical conditions might result in complications or death. Learn more from @CDCMMWR: http://bit.ly/MMWR6320   .pic.twitter.com/Z6tUdtTVL7
Emergency department data collected by CDC surveillance networks indicate some patients may be delaying emergency care during the #COVID19 pandemic. Fewer visits for critical conditions might result in complications or death. Learn more from @CDCMMWR: http://bit.ly/MMWR6320 . pic.twitter.com/Z6tUdtTVL7 (Source: Food and Drug Adminstration (FDA): CDRHNew)
Source: Food and Drug Adminstration (FDA): CDRHNew - June 3, 2020 Category: Medical Devices Authors: ( at CDCgov) Source Type: news

REMINDER https://twitter.com/FDADeviceInfo/status/1266434402919288836   …
REMINDER https://twitter.com/FDADeviceInfo/status/1266434402919288836 … (Source: Food and Drug Adminstration (FDA): CDRHNew)
Source: Food and Drug Adminstration (FDA): CDRHNew - June 3, 2020 Category: Medical Devices Authors: ( at FDADeviceInfo) Source Type: news

Consumer and health care personnel safety is a top priority for FDA. We ’ re working with industry to increase access to hand sanitizers and ensure that harmful levels of impurities are not present in ethanol used in these products. https://go.usa.gov/xwj9T   pic.twitter.com/KEtwKNB3Da
Consumer and health care personnel safety is a top priority for FDA. We’re working with industry to increase access to hand sanitizers and ensure that harmful levels of impurities are not present in ethanol used in these products. https://go.usa.gov/xwj9T  pic.twitter.com/KEtwKNB3Da (Source: Food and Drug Adminstration (FDA): CDRHNew)
Source: Food and Drug Adminstration (FDA): CDRHNew - June 2, 2020 Category: Medical Devices Authors: ( at US_FDA) Source Type: news

Today, @US_FDA is providing an update on Allergan ’ s latest actions to inform patients who may not be aware of the July 2019 BIOCELL breast implants and tissue expanders recall. Find out more. https://go.usa.gov/xwbRP  
Today, @US_FDA is providing an update on Allergan’s latest actions to inform patients who may not be aware of the July 2019 BIOCELL breast implants and tissue expanders recall. Find out more. https://go.usa.gov/xwbRP  (Source: Food and Drug Adminstration (FDA): CDRHNew)
Source: Food and Drug Adminstration (FDA): CDRHNew - June 1, 2020 Category: Medical Devices Authors: ( at FDADeviceInfo) Source Type: news

#DYK women are nearly 2x more likely to develop Alzheimer ’ s Disease compared to men? Researchers are conducting clinical trials to better understand this disease & inform future treatment. Learn more about clinical trials: http://www.clinicaltrials.gov   pic.twitter.com/6QdC0ZSy8z
#DYK women are nearly 2x more likely to develop Alzheimer’s Disease compared to men? Researchers are conducting clinical trials to better understand this disease & inform future treatment. Learn more about clinical trials: http://www.clinicaltrials.gov  pic.twitter.com/6QdC0ZSy8z (Source: Food and Drug Adminstration (FDA): CDRHNew)
Source: Food and Drug Adminstration (FDA): CDRHNew - June 1, 2020 Category: Medical Devices Authors: ( at FDAWomen) Source Type: news

Today kicks off National CPR and AED Awareness Week. Please consider taking a few minutes to learn more about the life-saving capabilities of automated external defibrillators and how to use them. https://go.usa.gov/xw4XT   #CPRAEDAwarenessWeek
Today kicks off National CPR and AED Awareness Week. Please consider taking a few minutes to learn more about the life-saving capabilities of automated external defibrillators and how to use them. https://go.usa.gov/xw4XT  #CPRAEDAwarenessWeek (Source: Food and Drug Adminstration (FDA): CDRHNew)
Source: Food and Drug Adminstration (FDA): CDRHNew - June 1, 2020 Category: Medical Devices Authors: ( at US_FDA) 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 June 3, 2020 12:15-1:15 ET. http://go.usa.gov/xv3hx   pic.twitter.com/WxLDFGp6uW
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 June 3, 2020 12:15-1:15 ET. http://go.usa.gov/xv3hx  pic.twitter.com/WxLDFGp6uW (Source: Food and Drug Adminstration (FDA): CDRHNew)
Source: Food and Drug Adminstration (FDA): CDRHNew - May 29, 2020 Category: Medical Devices Authors: ( at FDADeviceInfo) Source Type: news

Protect your water supply & ensure #foodsafety, by knowing what to do before, during & after a #storm https://go.usa.gov/xw4Kn   #HurricaneSeasonpic.twitter.com/lqbR93cWmn
Protect your water supply & ensure #foodsafety, by knowing what to do before, during & after a #storm https://go.usa.gov/xw4Kn  #HurricaneSeason pic.twitter.com/lqbR93cWmn (Source: Food and Drug Adminstration (FDA): CDRHNew)
Source: Food and Drug Adminstration (FDA): CDRHNew - May 29, 2020 Category: Medical Devices Authors: ( at FDAfood) Source Type: news

We're kicking off our 2020 Annual Public Forum next month with a fireside chat where @pgoldberg14 sits down with @SteveFDA to discuss shared goals and how @US_FDA is helping to battle #COVID19. Register at http://bit.ly/2I4117z   .pic.twitter.com/N90ZpmrdJ5
We're kicking off our 2020 Annual Public Forum next month with a fireside chat where @pgoldberg14 sits down with @SteveFDA to discuss shared goals and how @US_FDA is helping to battle #COVID19. Register at http://bit.ly/2I4117z . pic.twitter.com/N90ZpmrdJ5 (Source: Food and Drug Adminstration (FDA): CDRHNew)
Source: Food and Drug Adminstration (FDA): CDRHNew - May 29, 2020 Category: Medical Devices Authors: ( at MDIConline) Source Type: news

Do you have questions about glove shortages or manufacturing, purchasing, or importing gloves? Check out the @US_FDA ’ s comprehensive resource about medical gloves during the #COVID19 public health emergency. https://go.usa.gov/xw4D9  
Do you have questions about glove shortages or manufacturing, purchasing, or importing gloves? Check out the @US_FDA’s comprehensive resource about medical gloves during the #COVID19 public health emergency. https://go.usa.gov/xw4D9  (Source: Food and Drug Adminstration (FDA): CDRHNew)
Source: Food and Drug Adminstration (FDA): CDRHNew - May 29, 2020 Category: Medical Devices Authors: ( at FDADeviceInfo) Source Type: news

The clamp screws are at risk of breaking when tightening the strain relief clamp and outflow graft tears have been observed before, during, or shortly after implant. Find out more about this #MedicalDevice recall. https://go.usa.gov/xwgWw  
The clamp screws are at risk of breaking when tightening the strain relief clamp and outflow graft tears have been observed before, during, or shortly after implant. Find out more about this #MedicalDevice recall. https://go.usa.gov/xwgWw  (Source: Food and Drug Adminstration (FDA): CDRHNew)
Source: Food and Drug Adminstration (FDA): CDRHNew - May 28, 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 HeartWare HVAD Pump Outflow Graft and Outflow Graft Strain Relief Due to Risk of Breaks and Tears During Set Up.pic.twitter.com/m68O7tKrDG
Today, the @US_FDA identified a Class I Recall, the most serious type of recall: Medtronic Recalls HeartWare HVAD Pump Outflow Graft and Outflow Graft Strain Relief Due to Risk of Breaks and Tears During Set Up. pic.twitter.com/m68O7tKrDG (Source: Food and Drug Adminstration (FDA): CDRHNew)
Source: Food and Drug Adminstration (FDA): CDRHNew - May 28, 2020 Category: Medical Devices Authors: ( at FDADeviceInfo) Source Type: news

Learn about upcoming system enhancements to CDRH's Electronic #MedicalDevice Reporting (eMDR) system https://go.usa.gov/xwgrB  
Learn about upcoming system enhancements to CDRH's Electronic #MedicalDevice Reporting (eMDR) system https://go.usa.gov/xwgrB  (Source: Food and Drug Adminstration (FDA): CDRHNew)
Source: Food and Drug Adminstration (FDA): CDRHNew - May 28, 2020 Category: Medical Devices Authors: ( at FDADeviceInfo) Source Type: news

Thanks for all of your questions! Be sure to visit https://www.fda.gov/coronavirus   for all the latest in our efforts against #COVID19. #AskFDApic.twitter.com/TlP4726boW
Thanks for all of your questions! Be sure to visit https://www.fda.gov/coronavirus  for all the latest in our efforts against #COVID19. #AskFDA pic.twitter.com/TlP4726boW (Source: Food and Drug Adminstration (FDA): CDRHNew)
Source: Food and Drug Adminstration (FDA): CDRHNew - May 28, 2020 Category: Medical Devices Authors: ( at US_FDA) Source Type: news

FDA is providing a new tool to help in the development and evaluation of #COVID19 diagnostic tests. https://twitter.com/SteveFDA/status/1265979674108329985   …
FDA is providing a new tool to help in the development and evaluation of #COVID19 diagnostic tests. https://twitter.com/SteveFDA/status/1265979674108329985 … (Source: Food and Drug Adminstration (FDA): CDRHNew)
Source: Food and Drug Adminstration (FDA): CDRHNew - May 28, 2020 Category: Medical Devices Authors: ( at US_FDA) Source Type: news

There is still time to register for tomorrow's informational webinar on our draft framework on Real-World Evidence generation for In Vitro Diagnostics! Learn more: https://bit.ly/2WXZw10   pic.twitter.com/3Ydv0XEIUM
There is still time to register for tomorrow's informational webinar on our draft framework on Real-World Evidence generation for In Vitro Diagnostics! Learn more: https://bit.ly/2WXZw10  pic.twitter.com/3Ydv0XEIUM (Source: Food and Drug Adminstration (FDA): CDRHNew)
Source: Food and Drug Adminstration (FDA): CDRHNew - May 27, 2020 Category: Medical Devices Authors: ( at MDIConline) Source Type: news

The @US_FDA reminds reprocessing staff in health care facilities to use the correct cycle and compatible N95 respirators when decontaminating respirators with STERRAD Sterilization Systems. Find out more. https://go.usa.gov/xwr65   pic.twitter.com/TL6cYwvP5B
The @US_FDA reminds reprocessing staff in health care facilities to use the correct cycle and compatible N95 respirators when decontaminating respirators with STERRAD Sterilization Systems. Find out more. https://go.usa.gov/xwr65  pic.twitter.com/TL6cYwvP5B (Source: Food and Drug Adminstration (FDA): CDRHNew)
Source: Food and Drug Adminstration (FDA): CDRHNew - May 27, 2020 Category: Medical Devices Authors: ( at FDADeviceInfo) 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 May 27, 2020 12:15-1:15 ET. http://go.usa.gov/xv3hx   pic.twitter.com/OJ3frp7Ni7
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 May 27, 2020 12:15-1:15 ET. http://go.usa.gov/xv3hx  pic.twitter.com/OJ3frp7Ni7 (Source: Food and Drug Adminstration (FDA): CDRHNew)
Source: Food and Drug Adminstration (FDA): CDRHNew - May 26, 2020 Category: Medical Devices Authors: ( at FDADeviceInfo) Source Type: news

Every 2 seconds, someone in the U.S. needs blood. The #COVID19 pandemic has impacted the nation ’ s blood supply because of factors such as cancelled blood drives. If you are healthy & feel well, consider donating. Learn more here: https://go.usa.gov/xv7a8   pic.twitter.com/X8yYIbQ5LJ
Every 2 seconds, someone in the U.S. needs blood. The #COVID19 pandemic has impacted the nation’s blood supply because of factors such as cancelled blood drives. If you are healthy & feel well, consider donating. Learn more here: https://go.usa.gov/xv7a8  pic.twitter.com/X8yYIbQ5LJ (Source: Food and Drug Adminstration (FDA): CDRHNew)
Source: Food and Drug Adminstration (FDA): CDRHNew - May 20, 2020 Category: Medical Devices Authors: ( at US_FDA) Source Type: news

Have questions about device shortages, enforcement policies, and other #COVID19 related topics? Check out the @US_FDA ’ s comprehensive directory of email addresses for medical device questions during the #COVID19 pandemic. https://go.usa.gov/xvS85   pic.twitter.com/nitxGp2vIO
Have questions about device shortages, enforcement policies, and other #COVID19 related topics? Check out the @US_FDA’s comprehensive directory of email addresses for medical device questions during the #COVID19 pandemic. https://go.usa.gov/xvS85  pic.twitter.com/nitxGp2vIO (Source: Food and Drug Adminstration (FDA): CDRHNew)
Source: Food and Drug Adminstration (FDA): CDRHNew - May 20, 2020 Category: Medical Devices Authors: ( at FDADeviceInfo) Source Type: news

There are two different types of #COVID19 tests: diagnostic tests (molecular and antigen tests) and antibody tests. Learn more about #coronavirus testing (PDF): https://go.usa.gov/xvuK7   pic.twitter.com/IOd3tvJh8i
There are two different types of #COVID19 tests: diagnostic tests (molecular and antigen tests) and antibody tests. Learn more about #coronavirus testing (PDF): https://go.usa.gov/xvuK7  pic.twitter.com/IOd3tvJh8i (Source: Food and Drug Adminstration (FDA): CDRHNew)
Source: Food and Drug Adminstration (FDA): CDRHNew - May 20, 2020 Category: Medical Devices Authors: ( at FDA_MCMi) Source Type: news

FDA is committed to protecting the supply chain of imported PPE, #COVID19 test kits, drugs, & other medical devices to ensure products are safe, while stopping illegal, dangerous, & fraudulent products. Dr. Judy McMeekin shares an update on supply chain: https://www.fda.gov/news-events/fda-voices/covid-19-supply-chain-update-importation-vital-food-and-medical-products   …
FDA is committed to protecting the supply chain of imported PPE, #COVID19 test kits, drugs, & other medical devices to ensure products are safe, while stopping illegal, dangerous, & fraudulent products. Dr. Judy McMeekin shares an update on supply chain: https://www.fda.gov/news-events/fda-voices/covid-19-supply-chain-update-importation-vital-food-and-medical-products … (Source: Food and Drug Adminstration (FDA): CDRHNew)
Source: Food and Drug Adminstration (FDA): CDRHNew - May 20, 2020 Category: Medical Devices Authors: ( at US_FDA) 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 May 20, 2020 12:15-1:15 ET. http://go.usa.gov/xv3hx   pic.twitter.com/a2X4CUh0Kz
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 May 20, 2020 12:15-1:15 ET. http://go.usa.gov/xv3hx  pic.twitter.com/a2X4CUh0Kz (Source: Food and Drug Adminstration (FDA): CDRHNew)
Source: Food and Drug Adminstration (FDA): CDRHNew - May 19, 2020 Category: Medical Devices Authors: ( at FDADeviceInfo) Source Type: news

Wondering if disinfectant sprays or wipes can be used on your skin to prevent the spread of #COVID19? The answer is no Disinfectant sprays or wipes are not intended for use on humans or animals and should only be used on hard, non-porous surfaces. https://go.usa.gov/xv7aW   pic.twitter.com/RwHnTlNzaz
Wondering if disinfectant sprays or wipes can be used on your skin to prevent the spread of #COVID19? The answer is no Disinfectant sprays or wipes are not intended for use on humans or animals and should only be used on hard, non-porous surfaces. https://go.usa.gov/xv7aW  pic.twitter.com/RwHnTlNzaz (Source: Food and Drug Adminstration (FDA): CDRHNew)
Source: Food and Drug Adminstration (FDA): CDRHNew - May 19, 2020 Category: Medical Devices Authors: ( at US_FDA) Source Type: news

#FDAORA has not found evidence to suggest that transmission of #COVID19 is linked with imported goods (incl. food/medical products). MORE: https://go.usa.gov/xvuJT   pic.twitter.com/W9JHMhqpCS
#FDAORA has not found evidence to suggest that transmission of #COVID19 is linked with imported goods (incl. food/medical products). MORE: https://go.usa.gov/xvuJT  pic.twitter.com/W9JHMhqpCS (Source: Food and Drug Adminstration (FDA): CDRHNew)
Source: Food and Drug Adminstration (FDA): CDRHNew - May 19, 2020 Category: Medical Devices Authors: ( at FDA_ORA) Source Type: news

During the #COVID19 public health emergency, children may be home from school & you may have more hand sanitizer accessible. Be sure to keep all hand sanitizer products out of reach of children, and contact poison control if swallowed at 800-222-1222 or http://poison.org   pic.twitter.com/38GO4H9AHJ
During the #COVID19 public health emergency, children may be home from school & you may have more hand sanitizer accessible. Be sure to keep all hand sanitizer products out of reach of children, and contact poison control if swallowed at 800-222-1222 or http://poison.org  pic.twitter.com/38GO4H9AHJ (Source: Food and Drug Adminstration (FDA): CDRHNew)
Source: Food and Drug Adminstration (FDA): CDRHNew - May 18, 2020 Category: Medical Devices Authors: ( at US_FDA) Source Type: news

If you are displaying #COVID19 symptoms and want to get tested, call your state or local health department or a medical provider. Learn more at http://cdc.gov/coronavirus   @CDCgov
If you are displaying #COVID19 symptoms and want to get tested, call your state or local health department or a medical provider. Learn more at http://cdc.gov/coronavirus  @CDCgov (Source: Food and Drug Adminstration (FDA): CDRHNew)
Source: Food and Drug Adminstration (FDA): CDRHNew - May 15, 2020 Category: Medical Devices Authors: ( at FDADeviceInfo) Source Type: news

In response to the #COVID19 pandemic, @US_FDA has taken these steps since yesterday: https://www.fda.gov/news-events/press-announcements/coronavirus-covid-19-update-daily-roundup-may-14-2020   … pic.twitter.com/FGttxL6wYM
In response to the #COVID19 pandemic, @US_FDA has taken these steps since yesterday: https://www.fda.gov/news-events/press-announcements/coronavirus-covid-19-update-daily-roundup-may-14-2020 … pic.twitter.com/FGttxL6wYM (Source: Food and Drug Adminstration (FDA): CDRHNew)
Source: Food and Drug Adminstration (FDA): CDRHNew - May 15, 2020 Category: Medical Devices Authors: ( at SteveFDA) Source Type: news

#COVID19 is a disease caused by a #coronavirus, so antibiotics do not prevent or treat it. Remember to only take medications prescribed by a health care professional. https://go.usa.gov/xvvv4   pic.twitter.com/nKcdBF6oTF
#COVID19 is a disease caused by a #coronavirus, so antibiotics do not prevent or treat it. Remember to only take medications prescribed by a health care professional. https://go.usa.gov/xvvv4  pic.twitter.com/nKcdBF6oTF (Source: Food and Drug Adminstration (FDA): CDRHNew)
Source: Food and Drug Adminstration (FDA): CDRHNew - May 15, 2020 Category: Medical Devices Authors: ( at US_FDA) Source Type: news

In the spirit of transparency, FDA is alerting the public to early data suggesting potential inaccurate results during the Abbott ID NOW point of care #COVID19 test, specifically false negative results. https://go.usa.gov/xvM5b   pic.twitter.com/15Rh4Y50YN
In the spirit of transparency, FDA is alerting the public to early data suggesting potential inaccurate results during the Abbott ID NOW point of care #COVID19 test, specifically false negative results. https://go.usa.gov/xvM5b  pic.twitter.com/15Rh4Y50YN (Source: Food and Drug Adminstration (FDA): CDRHNew)
Source: Food and Drug Adminstration (FDA): CDRHNew - May 15, 2020 Category: Medical Devices Authors: ( at US_FDA) Source Type: news

Today, FDA sent warning letters to 2 breast implant makers as part of ongoing efforts to protect patients: Allergan did not comply w/ post-approval study requirements; Ideal Implant Inc. cited for failures w/ quality system & medical device reporting regs. https://go.usa.gov/xvMbA   pic.twitter.com/p60gRc5GdP
Today, FDA sent warning letters to 2 breast implant makers as part of ongoing efforts to protect patients: Allergan did not comply w/ post-approval study requirements; Ideal Implant Inc. cited for failures w/ quality system & medical device reporting regs. https://go.usa.gov/xvMbA  pic.twitter.com/p60gRc5GdP (Source: Food and Drug Adminstration (FDA): CDRHNew)
Source: Food and Drug Adminstration (FDA): CDRHNew - May 14, 2020 Category: Medical Devices Authors: ( at FDAMedia) Source Type: news

If someone in your home gets sick with #COVID19, do you know how to protect yourself and others? This video offers special cleaning advice: https://bit.ly/3a5uKZo   .pic.twitter.com/0Lr4HSp2OQ
If someone in your home gets sick with #COVID19, do you know how to protect yourself and others? This video offers special cleaning advice: https://bit.ly/3a5uKZo . pic.twitter.com/0Lr4HSp2OQ (Source: Food and Drug Adminstration (FDA): CDRHNew)
Source: Food and Drug Adminstration (FDA): CDRHNew - May 14, 2020 Category: Medical Devices Authors: ( at CDCgov) Source Type: news

During the town hall, we will also answer technical questions about research regarding the development and validation of swabs manufactured
(Source: Food and Drug Adminstration (FDA): CDRHNew)
Source: Food and Drug Adminstration (FDA): CDRHNew - May 13, 2020 Category: Medical Devices Authors: ( at FDADeviceInfo) Source Type: news

Flagging: On Friday May 15th from 1-2 p.m. ET, @US_FDA will host a virtual Town Hall for researchers, clinical laboratories & commercial manufacturers to discuss the production & use of 3D printed swabs during the #COVID19 public health emergency. https://go.usa.gov/xvFcV  
Flagging: On Friday May 15th from 1-2 p.m. ET, @US_FDA will host a virtual Town Hall for researchers, clinical laboratories & commercial manufacturers to discuss the production & use of 3D printed swabs during the #COVID19 public health emergency. https://go.usa.gov/xvFcV  (Source: Food and Drug Adminstration (FDA): CDRHNew)
Source: Food and Drug Adminstration (FDA): CDRHNew - May 13, 2020 Category: Medical Devices Authors: ( at FDADeviceInfo) Source Type: news

Experts from FDA, @DeptVetAffairs ’ Innovation Ecosystem, & @NIH ’ s 3D Print Exchange will discuss their collaborative scientific research on the design, manufacturing, & use of 3D printed swabs.
Experts from FDA, @DeptVetAffairs’ Innovation Ecosystem, & @NIH’s 3D Print Exchange will discuss their collaborative scientific research on the design, manufacturing, & use of 3D printed swabs. (Source: Food and Drug Adminstration (FDA): CDRHNew)
Source: Food and Drug Adminstration (FDA): CDRHNew - May 13, 2020 Category: Medical Devices Authors: ( at FDADeviceInfo) Source Type: news

Whether you are a health care professional, consumer, or patient, you can report any observed or suspected adverse events for drugs used to treat patients who have # COVID19 symptoms. Learn more about the type of info you should report to #MedWatch: http://www.fda.gov/medwatch   pic.twitter.com/EhpOa91zOu
Whether you are a health care professional, consumer, or patient, you can report any observed or suspected adverse events for drugs used to treat patients who have # COVID19 symptoms. Learn more about the type of info you should report to #MedWatch: http://www.fda.gov/medwatch  pic.twitter.com/EhpOa91zOu (Source: Food and Drug Adminstration (FDA): CDRHNew)
Source: Food and Drug Adminstration (FDA): CDRHNew - May 13, 2020 Category: Medical Devices Authors: ( at US_FDA) Source Type: news

FDA is working quickly every day to protect the public health during the #COVID19 pandemic. Here is our latest update: https://www.fda.gov/news-events/press-announcements/coronavirus-covid-19-update-daily-roundup-may-12-2020   … pic.twitter.com/MqRZLDEPIX
FDA is working quickly every day to protect the public health during the #COVID19 pandemic. Here is our latest update: https://www.fda.gov/news-events/press-announcements/coronavirus-covid-19-update-daily-roundup-may-12-2020 … pic.twitter.com/MqRZLDEPIX (Source: Food and Drug Adminstration (FDA): CDRHNew)
Source: Food and Drug Adminstration (FDA): CDRHNew - May 13, 2020 Category: Medical Devices Authors: ( at SteveFDA) Source Type: news

These catheters are at risk of tip detachment which could lead to pieces of the catheter breaking off. This could cause additional surgical procedures, damage to the blood vessel, or death. Find out more about the #MedicalDevice recall https://go.usa.gov/xvH6h  
These catheters are at risk of tip detachment which could lead to pieces of the catheter breaking off. This could cause additional surgical procedures, damage to the blood vessel, or death. Find out more about the #MedicalDevice recall https://go.usa.gov/xvH6h  (Source: Food and Drug Adminstration (FDA): CDRHNew)
Source: Food and Drug Adminstration (FDA): CDRHNew - May 12, 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: Applied Medical Recalls Python Embolectomy, BARD Embolectomy, and OTW Latis Cleaning Catheters Due to Risk of Separation During Use.pic.twitter.com/mBuBQKDipv
Today, the @US_FDA identified a Class I Recall, the most serious type of recall: Applied Medical Recalls Python Embolectomy, BARD Embolectomy, and OTW Latis Cleaning Catheters Due to Risk of Separation During Use. pic.twitter.com/mBuBQKDipv (Source: Food and Drug Adminstration (FDA): CDRHNew)
Source: Food and Drug Adminstration (FDA): CDRHNew - May 12, 2020 Category: Medical Devices Authors: ( at FDADeviceInfo) Source Type: news

It ’ s the start of National Women ’ s Health Week! If you are an expecting or new mom, check out @FDAWomen for information on safe medicine, breastfeeding, food safety and more! http://www.fda.gov/pregnancy   #NWHW #FindYourHealthpic.twitter.com/VQQbyjyQnm
It’s the start of National Women’s Health Week! If you are an expecting or new mom, check out @FDAWomen for information on safe medicine, breastfeeding, food safety and more! http://www.fda.gov/pregnancy  #NWHW #FindYourHealth pic.twitter.com/VQQbyjyQnm (Source: Food and Drug Adminstration (FDA): CDRHNew)
Source: Food and Drug Adminstration (FDA): CDRHNew - May 12, 2020 Category: Medical Devices Authors: ( at FDADeviceInfo) 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 May 13, 2020 12:15-1:15 ET. http://go.usa.gov/xv3hx   pic.twitter.com/BZdOBQtByD
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 May 13, 2020 12:15-1:15 ET. http://go.usa.gov/xv3hx  pic.twitter.com/BZdOBQtByD (Source: Food and Drug Adminstration (FDA): CDRHNew)
Source: Food and Drug Adminstration (FDA): CDRHNew - May 12, 2020 Category: Medical Devices Authors: ( at FDADeviceInfo) Source Type: news

CONSUMERS: Be cautious of websites and stores selling products claiming to prevent, treat, diagnose or cure #COVID19. Products for veterinary use, “ for research only, ” or otherwise not for human consumption have not been evaluated by FDA for human safety. https://go.usa.gov/xvG8G   pic.twitter.com/pC1LVU1L8u
CONSUMERS: Be cautious of websites and stores selling products claiming to prevent, treat, diagnose or cure #COVID19. Products for veterinary use, “for research only,” or otherwise not for human consumption have not been evaluated by FDA for human safety. https://go.usa.gov/xvG8G  pic.twitter.com/pC1LVU1L8u (Source: Food and Drug Adminstration (FDA): CDRHNew)
Source: Food and Drug Adminstration (FDA): CDRHNew - May 12, 2020 Category: Medical Devices Authors: ( at FDA_ORA) Source Type: news

It ’ s important for women to prioritize health in every stage of life. Check out our resources on pregnancy, menopause, healthy aging & more, available here: http://go.usa.gov/x9hqy   #NWHW #FindYourHealthpic.twitter.com/IqXvhSj2ku
It’s important for women to prioritize health in every stage of life. Check out our resources on pregnancy, menopause, healthy aging & more, available here: http://go.usa.gov/x9hqy  #NWHW #FindYourHealth pic.twitter.com/IqXvhSj2ku (Source: Food and Drug Adminstration (FDA): CDRHNew)
Source: Food and Drug Adminstration (FDA): CDRHNew - May 12, 2020 Category: Medical Devices Authors: ( at FDAWomen) Source Type: news

If you are aware of fraudulent #COVID19 test kits, you can help by reporting them to FDA's Health Fraud Program at FDA-COVID-19-Fraudulent-Products@fda.hhs.gov or https://go.usa.gov/xvwu4   pic.twitter.com/dqrzjHxNIY
If you are aware of fraudulent #COVID19 test kits, you can help by reporting them to FDA's Health Fraud Program at FDA-COVID-19-Fraudulent-Products@fda.hhs.gov or https://go.usa.gov/xvwu4  pic.twitter.com/dqrzjHxNIY (Source: Food and Drug Adminstration (FDA): CDRHNew)
Source: Food and Drug Adminstration (FDA): CDRHNew - May 12, 2020 Category: Medical Devices Authors: ( at US_FDA) Source Type: news

Today the @US_FDA updated the Policy for #COVID19 Tests During the Public Health Emergency. The update includes a new section that references the availability, on the FDA's website, EUA submission templates for molecular, antigen, and serology tests. https://go.usa.gov/xvsvh  
Today the @US_FDA updated the Policy for #COVID19 Tests During the Public Health Emergency. The update includes a new section that references the availability, on the FDA's website, EUA submission templates for molecular, antigen, and serology tests. https://go.usa.gov/xvsvh  (Source: Food and Drug Adminstration (FDA): CDRHNew)
Source: Food and Drug Adminstration (FDA): CDRHNew - May 11, 2020 Category: Medical Devices Authors: ( at FDADeviceInfo) Source Type: news

REMINDER: Today from 2-3 PM ET, the @US_FDA will host a webinar about the guidance, Notifying CDRH of a Permanent Discontinuance or Interruption in Manufacturing of a Device Under Section 506J of the FD & C Act During the #COVID19 Public Health Emergency. https://go.usa.gov/xvwXQ   pic.twitter.com/zntOq31lez
REMINDER: Today from 2-3 PM ET, the @US_FDA will host a webinar about the guidance, Notifying CDRH of a Permanent Discontinuance or Interruption in Manufacturing of a Device Under Section 506J of the FD&C Act During the #COVID19 Public Health Emergency. https://go.usa.gov/xvwXQ  pic.twitter.com/zntOq31lez (Source: Food and Drug Adminstration (FDA): CDRHNew)
Source: Food and Drug Adminstration (FDA): CDRHNew - May 11, 2020 Category: Medical Devices Authors: ( at FDADeviceInfo) Source Type: news

Friday, @FDAHealthEquity met with racial and ethnic minority leaders to help rapidly address concerns about some of America ’ s most vulnerable populations during the #COVID19 pandemic.
Friday, @FDAHealthEquity met with racial and ethnic minority leaders to help rapidly address concerns about some of America’s most vulnerable populations during the #COVID19 pandemic. (Source: Food and Drug Adminstration (FDA): CDRHNew)
Source: Food and Drug Adminstration (FDA): CDRHNew - May 9, 2020 Category: Medical Devices Authors: ( at US_FDA) Source Type: news