FDA fully supports partners looking to develop new diagnostic tools for #COVID19. Apply now to help! https://twitter.com/DepSecHargan/status/1228326692239880193   …
FDA fully supports partners looking to develop new diagnostic tools for #COVID19. Apply now to help! https://twitter.com/DepSecHargan/status/1228326692239880193 … (Source: Food and Drug Adminstration (FDA): CDRHNew)
Source: Food and Drug Adminstration (FDA): CDRHNew - February 14, 2020 Category: Medical Devices Authors: ( at SteveFDA) Source Type: news

Find more about the upcoming meeting and register today! https://go.usa.gov/xdRBx  
Find more about the upcoming meeting and register today! https://go.usa.gov/xdRBx  (Source: Food and Drug Adminstration (FDA): CDRHNew)
Source: Food and Drug Adminstration (FDA): CDRHNew - February 14, 2020 Category: Medical Devices Authors: ( at FDADeviceInfo) Source Type: news

The purpose of the workshop is to bring together experts from several disciplines and multiple sectors to discuss the appropriate study designs needed to demonstrate the safety and effectiveness of ctDNA cancer screening tests and to support claims of cancer screening.
(Source: Food and Drug Adminstration (FDA): CDRHNew)
Source: Food and Drug Adminstration (FDA): CDRHNew - February 14, 2020 Category: Medical Devices Authors: ( at FDADeviceInfo) Source Type: news

The @US_FDA supports the continued research and advancement of cancer screening tests. Join us on March 9, 2020 from 8:30 AM to 4:30 PM, as we discuss, “ Detecting Circulating Tumor DNA for Cancer Screening. ” pic.twitter.com/Bbs6Xnd5D7
The @US_FDA supports the continued research and advancement of cancer screening tests. Join us on March 9, 2020 from 8:30 AM to 4:30 PM, as we discuss, “Detecting Circulating Tumor DNA for Cancer Screening.” pic.twitter.com/Bbs6Xnd5D7 (Source: Food and Drug Adminstration (FDA): CDRHNew)
Source: Food and Drug Adminstration (FDA): CDRHNew - February 14, 2020 Category: Medical Devices Authors: ( at FDADeviceInfo) Source Type: news

Right now, there are 83 FDA Commissioned Corps from #USPHS deployed around the country to support our #COVID19 response efforts. These professionals are on the frontline and working to keep Americans safe. https://twitter.com/HHS_ASH/status/1228125040853516288   …
Right now, there are 83 FDA Commissioned Corps from #USPHS deployed around the country to support our #COVID19 response efforts. These professionals are on the frontline and working to keep Americans safe. https://twitter.com/HHS_ASH/status/1228125040853516288 … (Source: Food and Drug Adminstration (FDA): CDRHNew)
Source: Food and Drug Adminstration (FDA): CDRHNew - February 14, 2020 Category: Medical Devices Authors: ( at SteveFDA) Source Type: news

Registration is required by 4:00 PM EST on April 6, 2020. Find out more about the workshop. https://go.usa.gov/xdRb7  
Registration is required by 4:00 PM EST on April 6, 2020. Find out more about the workshop. https://go.usa.gov/xdRb7  (Source: Food and Drug Adminstration (FDA): CDRHNew)
Source: Food and Drug Adminstration (FDA): CDRHNew - February 14, 2020 Category: Medical Devices Authors: ( at FDADeviceInfo) Source Type: news

The purpose of this public workshop is to discuss modeling and simulation practices currently used in health technologies by industry and to develop a framework for evaluating and assessing the utility of computational modeling and simulation in health technologies
(Source: Food and Drug Adminstration (FDA): CDRHNew)
Source: Food and Drug Adminstration (FDA): CDRHNew - February 14, 2020 Category: Medical Devices Authors: ( at FDADeviceInfo) Source Type: news

Join us on April 13-15, 2020 (3 days), the @US_FDA will host a public workshop entitled “ Towards Good Simulation Practices in Health Technologies. ” pic.twitter.com/navUtbZK7N
Join us on April 13-15, 2020 (3 days), the @US_FDA will host a public workshop entitled “Towards Good Simulation Practices in Health Technologies.” pic.twitter.com/navUtbZK7N (Source: Food and Drug Adminstration (FDA): CDRHNew)
Source: Food and Drug Adminstration (FDA): CDRHNew - February 14, 2020 Category: Medical Devices Authors: ( at FDADeviceInfo) Source Type: news

The @US_FDA wants to continue to promote the advancement of the use of safe and effective technology in health care. In recent years, computational modeling has become an increasingly powerful tool for evaluating #MedicalDevices.
(Source: Food and Drug Adminstration (FDA): CDRHNew)
Source: Food and Drug Adminstration (FDA): CDRHNew - February 14, 2020 Category: Medical Devices Authors: ( at FDADeviceInfo) Source Type: news

Happy #ValentinesDay from all of us at FDA!pic.twitter.com/brzjC8TRIO
Happy #ValentinesDay from all of us at FDA! pic.twitter.com/brzjC8TRIO (Source: Food and Drug Adminstration (FDA): CDRHNew)
Source: Food and Drug Adminstration (FDA): CDRHNew - February 14, 2020 Category: Medical Devices Authors: ( at US_FDA) Source Type: news

#DYK African American women often have more heart attack risk factors than white women, such as high blood pressure, high cholesterol & diabetes? Get tips on managing these conditions & making #HeartHealthy decisions: http://www.fda.gov/womenshearthealth   … via @FDAWomen
#DYK African American women often have more heart attack risk factors than white women, such as high blood pressure, high cholesterol & diabetes? Get tips on managing these conditions & making #HeartHealthy decisions: http://www.fda.gov/womenshearthealth … via @FDAWomen (Source: Food and Drug Adminstration (FDA): CDRHNew)
Source: Food and Drug Adminstration (FDA): CDRHNew - February 13, 2020 Category: Medical Devices Authors: ( at US_FDA) Source Type: news

We're looking forward to this meeting! #PatientEngagement https://twitter.com/MDIConline/status/1225552020368699392   …
We're looking forward to this meeting! #PatientEngagement https://twitter.com/MDIConline/status/1225552020368699392 … (Source: Food and Drug Adminstration (FDA): CDRHNew)
Source: Food and Drug Adminstration (FDA): CDRHNew - February 13, 2020 Category: Medical Devices Authors: ( at FDADeviceInfo) Source Type: news

A missing or broken retainer ring could cause under or over delivery of insulin. This may cause patient injury or death. Find out more about the recall. https://go.usa.gov/xd59C  
A missing or broken retainer ring could cause under or over delivery of insulin. This may cause patient injury or death. Find out more about the recall. https://go.usa.gov/xd59C  (Source: Food and Drug Adminstration (FDA): CDRHNew)
Source: Food and Drug Adminstration (FDA): CDRHNew - February 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: Medtronic Recalls MiniMed Insulin Pumps for incorrect insulin dosing.pic.twitter.com/qcg5tFiznt
Today, the @US_FDA identified a Class I Recall, the most serious type of recall: Medtronic Recalls MiniMed Insulin Pumps for incorrect insulin dosing. pic.twitter.com/qcg5tFiznt (Source: Food and Drug Adminstration (FDA): CDRHNew)
Source: Food and Drug Adminstration (FDA): CDRHNew - February 12, 2020 Category: Medical Devices Authors: ( at FDADeviceInfo) Source Type: news

This guidance is intended to help manufacturers evaluate their device, enhance consistency of performance testing, and promote the safe use of these devices in clinical settings. Find out more. https://go.usa.gov/xd58F  
This guidance is intended to help manufacturers evaluate their device, enhance consistency of performance testing, and promote the safe use of these devices in clinical settings. Find out more. https://go.usa.gov/xd58F  (Source: Food and Drug Adminstration (FDA): CDRHNew)
Source: Food and Drug Adminstration (FDA): CDRHNew - February 12, 2020 Category: Medical Devices Authors: ( at FDADeviceInfo) Source Type: news

Today, the @US_FDA issued the final guidance titled, Peripheral Vascular Atherectomy Devices – Premarket Notification [510(k)] Submissions. The guidance applies to atherectomy devices used in the peripheral vasculature, which are classified by the FDA as class II devices.pic.twitter.com/IcedRwj5DZ
Today, the @US_FDA issued the final guidance titled, Peripheral Vascular Atherectomy Devices – Premarket Notification [510(k)] Submissions. The guidance applies to atherectomy devices used in the peripheral vasculature, which are classified by the FDA as class II devices. pic.twitter.com/IcedRwj5DZ (Source: Food and Drug Adminstration (FDA): CDRHNew)
Source: Food and Drug Adminstration (FDA): CDRHNew - February 12, 2020 Category: Medical Devices Authors: ( at FDADeviceInfo) Source Type: news

Is age a risk factor for heart disease? Hear what women like you had to say about heart disease, including risk factors & heart attack symptoms. #HeartMonthpic.twitter.com/xkYqcolCOz
Is age a risk factor for heart disease? Hear what women like you had to say about heart disease, including risk factors & heart attack symptoms. #HeartMonth pic.twitter.com/xkYqcolCOz (Source: Food and Drug Adminstration (FDA): CDRHNew)
Source: Food and Drug Adminstration (FDA): CDRHNew - February 11, 2020 Category: Medical Devices Authors: ( at FDAWomen) Source Type: news

FDA has experts fully engaged in efforts to develop diagnostics, vaccines & therapeutics for #2019nCoV. We are working closely with our government & international partners on these efforts to share information & collaborate. https://www.fda.gov/novelcoronavirus   …
FDA has experts fully engaged in efforts to develop diagnostics, vaccines & therapeutics for #2019nCoV. We are working closely with our government & international partners on these efforts to share information & collaborate. https://www.fda.gov/novelcoronavirus … (Source: Food and Drug Adminstration (FDA): CDRHNew)
Source: Food and Drug Adminstration (FDA): CDRHNew - February 10, 2020 Category: Medical Devices Authors: ( at SteveFDA) Source Type: news

Since 1994, FDA ’ s Office of Women ’ s Health has funded studies providing valuable insight into sex differences in the diagnosis & treatment of heart disease, leading to a better understanding of the disease in women. Learn about current research here: https://go.usa.gov/xmuxW   pic.twitter.com/JfaOhoY2q9
Since 1994, FDA’s Office of Women’s Health has funded studies providing valuable insight into sex differences in the diagnosis & treatment of heart disease, leading to a better understanding of the disease in women. Learn about current research here: https://go.usa.gov/xmuxW  pic.twitter.com/JfaOhoY2q9 (Source: Food and Drug Adminstration (FDA): CDRHNew)
Source: Food and Drug Adminstration (FDA): CDRHNew - February 10, 2020 Category: Medical Devices Authors: ( at US_FDA) Source Type: news

Heart disease is the leading cause of death for U.S. men and women. And many @US_FDA regulated devices are used to treat various heart issues. Find out more about these devices that help keep the heart beating. https://go.usa.gov/xd9mB   #HearthHealthMonth
Heart disease is the leading cause of death for U.S. men and women. And many @US_FDA regulated devices are used to treat various heart issues. Find out more about these devices that help keep the heart beating. https://go.usa.gov/xd9mB  #HearthHealthMonth (Source: Food and Drug Adminstration (FDA): CDRHNew)
Source: Food and Drug Adminstration (FDA): CDRHNew - February 10, 2020 Category: Medical Devices Authors: ( at FDADeviceInfo) Source Type: news

FDA will join the global observance of Rare Disease Day 2020 raising awareness about the 7,000 known rare diseases, many of which have no treatment. #FDARare2020 #rarediseaseday Join us at our public meeting on February 24, 2020 https://go.usa.gov/xdTqf   pic.twitter.com/nDS7LA0MrO
FDA will join the global observance of Rare Disease Day 2020 raising awareness about the 7,000 known rare diseases, many of which have no treatment. #FDARare2020 #rarediseaseday Join us at our public meeting on February 24, 2020 https://go.usa.gov/xdTqf  pic.twitter.com/nDS7LA0MrO (Source: Food and Drug Adminstration (FDA): CDRHNew)
Source: Food and Drug Adminstration (FDA): CDRHNew - February 10, 2020 Category: Medical Devices Authors: ( at FDAPatientinfo) Source Type: news

A loose cable connection could cause the loss of mechanical ventilation which could lead to serious injury or death. Find out more about the recall. #MedicalDevice https://go.usa.gov/xdkJZ  
A loose cable connection could cause the loss of mechanical ventilation which could lead to serious injury or death. Find out more about the recall. #MedicalDevice https://go.usa.gov/xdkJZ  (Source: Food and Drug Adminstration (FDA): CDRHNew)
Source: Food and Drug Adminstration (FDA): CDRHNew - February 7, 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: GE Healthcare Recalls Carestation 620/650/650c A1 Anesthesia Systems Due to Loss of Mechanical Ventilationpic.twitter.com/OPhmbeALeF
Today, the @US_FDA identified a Class I Recall, the most serious type of recall: GE Healthcare Recalls Carestation 620/650/650c A1 Anesthesia Systems Due to Loss of Mechanical Ventilation pic.twitter.com/OPhmbeALeF (Source: Food and Drug Adminstration (FDA): CDRHNew)
Source: Food and Drug Adminstration (FDA): CDRHNew - February 7, 2020 Category: Medical Devices Authors: ( at FDADeviceInfo) Source Type: news

OWH goes red in honor of #HeartMonth & #WearRedDay! Check out our tips on how you and your loved ones can improve your #HeartHealth today! http://www.fda.gov/womenshearthealth   … pic.twitter.com/VmC9J32K8S
OWH goes red in honor of #HeartMonth & #WearRedDay! Check out our tips on how you and your loved ones can improve your #HeartHealth today! http://www.fda.gov/womenshearthealth … pic.twitter.com/VmC9J32K8S (Source: Food and Drug Adminstration (FDA): CDRHNew)
Source: Food and Drug Adminstration (FDA): CDRHNew - February 7, 2020 Category: Medical Devices Authors: ( at FDAWomen) Source Type: news

It ’ s #BurnAwarenessWeek and the FDA wants to remind consumers that UV radiation in tanning devices and sunlamps pose serious health risks including skin burns. Protect your skin and find out more about these devices: https://go.usa.gov/xdkc3   pic.twitter.com/QnXKmYVP2F
It’s #BurnAwarenessWeek and the FDA wants to remind consumers that UV radiation in tanning devices and sunlamps pose serious health risks including skin burns. Protect your skin and find out more about these devices: https://go.usa.gov/xdkc3  pic.twitter.com/QnXKmYVP2F (Source: Food and Drug Adminstration (FDA): CDRHNew)
Source: Food and Drug Adminstration (FDA): CDRHNew - February 6, 2020 Category: Medical Devices Authors: ( at FDADeviceInfo) Source Type: news

Today, FDA issued an EUA for @CDCgov diagnostic to detect #2019nCoV novel #coronavirus. Its use is authorized for patients who meet CDC criteria for 2019-nCoV testing & is limited to qualified labs designated by CDC & in US, those certified to perform high complexity tests.pic.twitter.com/eZYgFsz57K
Today, FDA issued an EUA for @CDCgov diagnostic to detect #2019nCoV novel #coronavirus. Its use is authorized for patients who meet CDC criteria for 2019-nCoV testing & is limited to qualified labs designated by CDC & in US, those certified to perform high complexity tests. pic.twitter.com/eZYgFsz57K (Source: Food and Drug Adminstration (FDA): CDRHNew)
Source: Food and Drug Adminstration (FDA): CDRHNew - February 4, 2020 Category: Medical Devices Authors: ( at US_FDA) Source Type: news

Today ’ s EUA is the result of the close collaboration between FDA and @CDCgov to prioritize and rapidly respond to the need to develop critical medical products as part of the US Govt response to the #coronavirus outbreak. #2019nCoVpic.twitter.com/4GwJ9Azjry
Today’s EUA is the result of the close collaboration between FDA and @CDCgov to prioritize and rapidly respond to the need to develop critical medical products as part of the US Govt response to the #coronavirus outbreak. #2019nCoV pic.twitter.com/4GwJ9Azjry (Source: Food and Drug Adminstration (FDA): CDRHNew)
Source: Food and Drug Adminstration (FDA): CDRHNew - February 4, 2020 Category: Medical Devices Authors: ( at SteveFDA) Source Type: news

A manufacturing problem could cause the displayed oxygen values to be incorrect which could lead to serious injury or death. Find out more about the recall. https://go.usa.gov/xdB9w  
A manufacturing problem could cause the displayed oxygen values to be incorrect which could lead to serious injury or death. Find out more about the recall. https://go.usa.gov/xdB9w  (Source: Food and Drug Adminstration (FDA): CDRHNew)
Source: Food and Drug Adminstration (FDA): CDRHNew - February 4, 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: GE Healthcare Recalls CARESCAPE Respiratory Modules Due to Incorrect Oxygen Values.pic.twitter.com/jFl1s95W9w
Today, the @US_FDA identified a Class I Recall, the most serious type of recall: GE Healthcare Recalls CARESCAPE Respiratory Modules Due to Incorrect Oxygen Values. pic.twitter.com/jFl1s95W9w (Source: Food and Drug Adminstration (FDA): CDRHNew)
Source: Food and Drug Adminstration (FDA): CDRHNew - February 4, 2020 Category: Medical Devices Authors: ( at FDADeviceInfo) Source Type: news

#HeartMonth #HeartHealth #FDA #MedicalDevicepic.twitter.com/9mv3osCmXK
#HeartMonth #HeartHealth #FDA #MedicalDevice pic.twitter.com/9mv3osCmXK (Source: Food and Drug Adminstration (FDA): CDRHNew)
Source: Food and Drug Adminstration (FDA): CDRHNew - February 4, 2020 Category: Medical Devices Authors: ( at FDADeviceInfo) Source Type: news

Today, FDA cohosted a public workshop with @MDIConline on Advancing Emergency Use Diagnostic Products Toward Full Marketing Status. Planned well before the #coronavirus outbreak, it ’ s especially timely now. http://bit.ly/36WxpC2   pic.twitter.com/YAkUgNSqqp
Today, FDA cohosted a public workshop with @MDIConline on Advancing Emergency Use Diagnostic Products Toward Full Marketing Status. Planned well before the #coronavirus outbreak, it’s especially timely now. http://bit.ly/36WxpC2  pic.twitter.com/YAkUgNSqqp (Source: Food and Drug Adminstration (FDA): CDRHNew)
Source: Food and Drug Adminstration (FDA): CDRHNew - February 4, 2020 Category: Medical Devices Authors: ( at SteveFDA) Source Type: news

Visit @MinorityHealth's Black History Month webpage throughout February for resources, events and more. Help increase awareness about the impact heart disease has on the African American community and the benefits of an #activeandhealthy lifestyle. #BHM http://www.minorityhealth.hhs.gov/omh/browse.aspx?lvl=3 & lvlid=13   … pic.twitter.com/kWstENokDh
Visit @MinorityHealth's Black History Month webpage throughout February for resources, events and more. Help increase awareness about the impact heart disease has on the African American community and the benefits of an #activeandhealthy lifestyle. #BHM http://www.minorityhealth.hhs.gov/omh/browse.aspx?lvl=3&lvlid=13 … pic.twitter.com/kWstENokDh (Source: Food and Drug Adminstration (FDA): CDRHNew)
Source: Food and Drug Adminstration (FDA): CDRHNew - February 3, 2020 Category: Medical Devices Authors: ( at HHS_ASH) Source Type: news

.@SecAzar ’ s declaration of a Public Health Emergency on novel #coronavirus is part of the Administration ’ s work to monitor, respond to, and mitigate the spread of the #coronavirus. At this time, the risk to the American public remains low. https://twitter.com/SecAzar/status/1223346974264561665   …
. @SecAzar’s declaration of a Public Health Emergency on novel #coronavirus is part of the Administration’s work to monitor, respond to, and mitigate the spread of the #coronavirus. At this time, the risk to the American public remains low. https://twitter.com/SecAzar/status/1223346974264561665 … (Source: Food and Drug Adminstration (FDA): CDRHNew)
Source: Food and Drug Adminstration (FDA): CDRHNew - February 1, 2020 Category: Medical Devices Authors: ( at SteveFDA) Source Type: news

The Pressure Relief Manifold does not hold pressure when initially set up on a patient. This issue is due to a dislodged valve not being properly seated, resulting in loss of pressure in the system. Find out more about the recall. https://go.usa.gov/xdTSB  
The Pressure Relief Manifold does not hold pressure when initially set up on a patient. This issue is due to a dislodged valve not being properly seated, resulting in loss of pressure in the system. Find out more about the recall. https://go.usa.gov/xdTSB  (Source: Food and Drug Adminstration (FDA): CDRHNew)
Source: Food and Drug Adminstration (FDA): CDRHNew - January 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: Teleflex Recalls the Galemed http://Babi.Plus   Pressure Relief Manifolds Due to Dislodged Valve.pic.twitter.com/Whzh0vrLa9
Today, the @US_FDA identified a Class I Recall, the most serious type of recall: Teleflex Recalls the Galemed http://Babi.Plus  Pressure Relief Manifolds Due to Dislodged Valve. pic.twitter.com/Whzh0vrLa9 (Source: Food and Drug Adminstration (FDA): CDRHNew)
Source: Food and Drug Adminstration (FDA): CDRHNew - January 28, 2020 Category: Medical Devices Authors: ( at FDADeviceInfo) Source Type: news

On April 1, 2020, the @US_FDA will hold a public meeting, Communications About the Safety of Medical Devices. During this meeting, we plan to discuss the development, content & format of the FDA ’ s safety communications for medical devices: https://go.usa.gov/xdTdh   pic.twitter.com/gkN3Ou9Dbg
On April 1, 2020, the @US_FDA will hold a public meeting, Communications About the Safety of Medical Devices. During this meeting, we plan to discuss the development, content & format of the FDA’s safety communications for medical devices: https://go.usa.gov/xdTdh  pic.twitter.com/gkN3Ou9Dbg (Source: Food and Drug Adminstration (FDA): CDRHNew)
Source: Food and Drug Adminstration (FDA): CDRHNew - January 28, 2020 Category: Medical Devices Authors: ( at FDADeviceInfo) Source Type: news

If you're planning a big spread for the #BigGame & aren't sure how quickly food will be eaten, keep the serving dishes small & refill as needed. We've got more advice for #FoodSafety at https://go.usa.gov/xdTmh   pic.twitter.com/kOYoULUGeK
If you're planning a big spread for the #BigGame & aren't sure how quickly food will be eaten, keep the serving dishes small & refill as needed. We've got more advice for #FoodSafety at https://go.usa.gov/xdTmh  pic.twitter.com/kOYoULUGeK (Source: Food and Drug Adminstration (FDA): CDRHNew)
Source: Food and Drug Adminstration (FDA): CDRHNew - January 28, 2020 Category: Medical Devices Authors: ( at FDAfood) Source Type: news

CORONAVIRUS UPDATE: Today at 11:15 AM ET, join @SecAzar, @CDCDirector, @DrNancyM_CDC & @NIAIDNews ’ s Director Anthony Fauci for an update on the HHS response to the Novel Coronavirus. Watch live on HHS Twitter.pic.twitter.com/4ZquBfJfvv
CORONAVIRUS UPDATE: Today at 11:15 AM ET, join @SecAzar, @CDCDirector, @DrNancyM_CDC & @NIAIDNews’s Director Anthony Fauci for an update on the HHS response to the Novel Coronavirus. Watch live on HHS Twitter. pic.twitter.com/4ZquBfJfvv (Source: Food and Drug Adminstration (FDA): CDRHNew)
Source: Food and Drug Adminstration (FDA): CDRHNew - January 28, 2020 Category: Medical Devices Authors: ( at HHSGov) Source Type: news

Making guacamole for the #BigGame? Wash fruits and veggies before cutting or eating, even if you aren ’ t eating the peel. When knives cut thorough an unwashed peel, germs can spread into produce. Learn more: https://go.usa.gov/xpF9G   pic.twitter.com/M22wDWg3Ur
Making guacamole for the #BigGame? Wash fruits and veggies before cutting or eating, even if you aren’t eating the peel. When knives cut thorough an unwashed peel, germs can spread into produce. Learn more: https://go.usa.gov/xpF9G  pic.twitter.com/M22wDWg3Ur (Source: Food and Drug Adminstration (FDA): CDRHNew)
Source: Food and Drug Adminstration (FDA): CDRHNew - January 28, 2020 Category: Medical Devices Authors: ( at foodsafetygov) Source Type: news

The 2020 ELP Site Visit Proposal period is now open through Monday February 24th at 12 PM EST. And we encourage stakeholders to submit applications to the ELP Program Manager. Find out everything you need to know about this year ’ s application process https://go.usa.gov/xd2pS   pic.twitter.com/c4E6EEpAXE
The 2020 ELP Site Visit Proposal period is now open through Monday February 24th at 12 PM EST. And we encourage stakeholders to submit applications to the ELP Program Manager. Find out everything you need to know about this year’s application process https://go.usa.gov/xd2pS  pic.twitter.com/c4E6EEpAXE (Source: Food and Drug Adminstration (FDA): CDRHNew)
Source: Food and Drug Adminstration (FDA): CDRHNew - January 27, 2020 Category: Medical Devices Authors: ( at FDADeviceInfo) Source Type: news

The @US_FDA ’ s Experiential Learning Program (ELP) is a collaborative approach to closing the knowledge gap between emerging and innovative technology and the pre-market review of the resulting medical devices.
The @US_FDA’s Experiential Learning Program (ELP) is a collaborative approach to closing the knowledge gap between emerging and innovative technology and the pre-market review of the resulting medical devices. (Source: Food and Drug Adminstration (FDA): CDRHNew)
Source: Food and Drug Adminstration (FDA): CDRHNew - January 27, 2020 Category: Medical Devices Authors: ( at FDADeviceInfo) Source Type: news

We encourage you to read this draft guidance and provide your comments to the FDA by March 30, 2020. https://go.usa.gov/xd2pw  
We encourage you to read this draft guidance and provide your comments to the FDA by March 30, 2020. https://go.usa.gov/xd2pw  (Source: Food and Drug Adminstration (FDA): CDRHNew)
Source: Food and Drug Adminstration (FDA): CDRHNew - January 27, 2020 Category: Medical Devices Authors: ( at FDADeviceInfo) Source Type: news

Today, the @US_FDA issued a draft guidance for device manufacturers of arthroscopy pump tubing sets intended for multiple patient use. The draft guidance includes recommendations to mitigate the risk of infection, outline device design considerations, & risk mitigation strategiespic.twitter.com/sQJtAHKidx
Today, the @US_FDA issued a draft guidance for device manufacturers of arthroscopy pump tubing sets intended for multiple patient use. The draft guidance includes recommendations to mitigate the risk of infection, outline device design considerations, & risk mitigation strategies pic.twitter.com/sQJtAHKidx (Source: Food and Drug Adminstration (FDA): CDRHNew)
Source: Food and Drug Adminstration (FDA): CDRHNew - January 27, 2020 Category: Medical Devices Authors: ( at FDADeviceInfo) Source Type: news

Arthroscopy pump tubing sets are important surgical tools used to inspect, diagnose, and repair problems inside a joint. The tubing set is designed to deliver irrigation fluid to joint surgical sites, such as the knee, shoulder, hip and elbow.
(Source: Food and Drug Adminstration (FDA): CDRHNew)
Source: Food and Drug Adminstration (FDA): CDRHNew - January 27, 2020 Category: Medical Devices Authors: ( at FDADeviceInfo) Source Type: news

At the FDA, we are working hard to prepare, mitigate & respond to #coronavirus, in close coordination with our federal partners. This collaboration, as @SecAzar noted, reflects our shared commitment to public health.pic.twitter.com/brZWfLodGz
At the FDA, we are working hard to prepare, mitigate & respond to #coronavirus, in close coordination with our federal partners. This collaboration, as @SecAzar noted, reflects our shared commitment to public health. pic.twitter.com/brZWfLodGz (Source: Food and Drug Adminstration (FDA): CDRHNew)
Source: Food and Drug Adminstration (FDA): CDRHNew - January 27, 2020 Category: Medical Devices Authors: ( at SteveFDA) Source Type: news

These devices are used mostly in health care facilities for displaying information, such as temperature, heartbeat, and blood pressure. Find out more about the issue in our Safety Communication. https://go.usa.gov/xdggu  
These devices are used mostly in health care facilities for displaying information, such as temperature, heartbeat, and blood pressure. Find out more about the issue in our Safety Communication. https://go.usa.gov/xdggu  (Source: Food and Drug Adminstration (FDA): CDRHNew)
Source: Food and Drug Adminstration (FDA): CDRHNew - January 23, 2020 Category: Medical Devices Authors: ( at FDADeviceInfo) Source Type: news

The @US_FDA is raising awareness among health care providers and patients about cybersecurity vulnerabilities in certain GE Healthcare Clinical Information Central Stations and Telemetry Servers that may introduce risks to patients while being monitored.pic.twitter.com/o99keBw0cq
The @US_FDA is raising awareness among health care providers and patients about cybersecurity vulnerabilities in certain GE Healthcare Clinical Information Central Stations and Telemetry Servers that may introduce risks to patients while being monitored. pic.twitter.com/o99keBw0cq (Source: Food and Drug Adminstration (FDA): CDRHNew)
Source: Food and Drug Adminstration (FDA): CDRHNew - January 23, 2020 Category: Medical Devices Authors: ( at FDADeviceInfo) Source Type: news

The @US_FDA has issued a final order to reclassify certain radiological medical image analyzers, including CADe devices, from Class III devices to Class II devices. Find out more about the Final Order https://go.usa.gov/xdrts  
The @US_FDA has issued a final order to reclassify certain radiological medical image analyzers, including CADe devices, from Class III devices to Class II devices. Find out more about the Final Order https://go.usa.gov/xdrts  (Source: Food and Drug Adminstration (FDA): CDRHNew)
Source: Food and Drug Adminstration (FDA): CDRHNew - January 22, 2020 Category: Medical Devices Authors: ( at FDADeviceInfo) Source Type: news

Medical image analyzers including computer-assisted/aided detection (CADe) devices for mammography breast cancer and other analyzers are important systems that help doctors interpret medical images.
(Source: Food and Drug Adminstration (FDA): CDRHNew)
Source: Food and Drug Adminstration (FDA): CDRHNew - January 22, 2020 Category: Medical Devices Authors: ( at FDADeviceInfo) Source Type: news

Today, the @US_FDA cleared another duodenoscope with a disposable endcap that facilitates reprocessing. Learn more about this and all other cleared duodenoscopes with disposable components inside the blue box update found on our duodenoscopes page. https://go.usa.gov/xdaBE  
Today, the @US_FDA cleared another duodenoscope with a disposable endcap that facilitates reprocessing. Learn more about this and all other cleared duodenoscopes with disposable components inside the blue box update found on our duodenoscopes page. https://go.usa.gov/xdaBE  (Source: Food and Drug Adminstration (FDA): CDRHNew)
Source: Food and Drug Adminstration (FDA): CDRHNew - January 17, 2020 Category: Medical Devices Authors: ( at FDADeviceInfo) Source Type: news