Next week is Healthy Contact Week. Join the @CDCgov for a Facebook Live chat on Monday August 20th at 2 PM for a conversation on contact lens use. http://facebook.com/CDC/   #OnePairTakeCarepic.twitter.com/7HDQYrdPBv
Next week is Healthy Contact Week. Join the @CDCgov for a Facebook Live chat on Monday August 20th at 2 PM for a conversation on contact lens use. http://facebook.com/CDC/  #OnePairTakeCare pic.twitter.com/7HDQYrdPBv (Source: Food and Drug Adminstration (FDA): CDRHNew)
Source: Food and Drug Adminstration (FDA): CDRHNew - August 17, 2018 Category: Medical Devices Authors: ( at FDADeviceInfo) Source Type: news

#FDA issues letter to healthcare providers on the final post-approval study results & risks associated with #SynCardia TAH-t: C2 Driver System. https://go.usa.gov/xUeYd   #MedicalDevices
#FDA issues letter to healthcare providers on the final post-approval study results & risks associated with #SynCardia TAH-t: C2 Driver System. https://go.usa.gov/xUeYd  #MedicalDevices (Source: Food and Drug Adminstration (FDA): CDRHNew)
Source: Food and Drug Adminstration (FDA): CDRHNew - August 17, 2018 Category: Medical Devices Authors: ( at FDADeviceInfo) Source Type: news

#FDA issues FR notice on proposed list of #MedicalDevice accessories suitable for class I. Comments open for 60 days. View the list here: https://go.usa.gov/xUe37   #FDARA
#FDA issues FR notice on proposed list of #MedicalDevice accessories suitable for class I. Comments open for 60 days. View the list here: https://go.usa.gov/xUe37  #FDARA (Source: Food and Drug Adminstration (FDA): CDRHNew)
Source: Food and Drug Adminstration (FDA): CDRHNew - August 17, 2018 Category: Medical Devices Authors: ( at FDADeviceInfo) Source Type: news

We are excited by all the feedback we received over the last two days during the Pediatric Medical Device Development meeting. All presentation materials will be available on the Pediatric Medical Device webpage at https://go.usa.gov/xUF39   #Devices4Kids #MedicalDevicepic.twitter.com/XGwlpgopGn
We are excited by all the feedback we received over the last two days during the Pediatric Medical Device Development meeting. All presentation materials will be available on the Pediatric Medical Device webpage at https://go.usa.gov/xUF39  #Devices4Kids #MedicalDevice pic.twitter.com/XGwlpgopGn (Source: Food and Drug Adminstration (FDA): CDRHNew)
Source: Food and Drug Adminstration (FDA): CDRHNew - August 14, 2018 Category: Medical Devices Authors: ( at FDADeviceInfo) Source Type: news

Today is Day 2 of the Pediatric Medical Device Public Meeting. Today we will be discussing the importance of International Regulation Harmonization. https://go.usa.gov/xU6rg   #Devices4Kids #MedicalDevicepic.twitter.com/bMYgjX8CTX
Today is Day 2 of the Pediatric Medical Device Public Meeting. Today we will be discussing the importance of International Regulation Harmonization. https://go.usa.gov/xU6rg  #Devices4Kids #MedicalDevice pic.twitter.com/bMYgjX8CTX (Source: Food and Drug Adminstration (FDA): CDRHNew)
Source: Food and Drug Adminstration (FDA): CDRHNew - August 14, 2018 Category: Medical Devices Authors: ( at FDADeviceInfo) Source Type: news

We thank the participants that joined in person and remotely during Day 1 of the Pediatric Medical Device Development public meeting. We look forward to continuing discussions around increasing medical device options for children today. #Devices4Kids #MedicalDevicepic.twitter.com/7cXPFfvfif
We thank the participants that joined in person and remotely during Day 1 of the Pediatric Medical Device Development public meeting. We look forward to continuing discussions around increasing medical device options for children today. #Devices4Kids #MedicalDevice pic.twitter.com/7cXPFfvfif (Source: Food and Drug Adminstration (FDA): CDRHNew)
Source: Food and Drug Adminstration (FDA): CDRHNew - August 14, 2018 Category: Medical Devices Authors: ( at FDADeviceInfo) Source Type: news

FDA Commissioner, @SGottliebFDA , speaking during day 1 of the Pediatric Medical Device Development Public Meeting #devices4kids #FDA #MedicalDevicepic.twitter.com/0I1Poe9Yqn
FDA Commissioner, @SGottliebFDA , speaking during day 1 of the Pediatric Medical Device Development Public Meeting #devices4kids #FDA #MedicalDevice pic.twitter.com/0I1Poe9Yqn (Source: Food and Drug Adminstration (FDA): CDRHNew)
Source: Food and Drug Adminstration (FDA): CDRHNew - August 14, 2018 Category: Medical Devices Authors: ( at FDADeviceInfo) Source Type: news

More highlights from today's Pediatric Medical Device Development Public Meeting: Dr. Michelle Tarver of CDRH highlighting that collaboration is imperative in helping to promote pediatric device development. #devices4kids #MedicalDevicepic.twitter.com/mzlmU6Nq9U
More highlights from today's Pediatric Medical Device Development Public Meeting: Dr. Michelle Tarver of CDRH highlighting that collaboration is imperative in helping to promote pediatric device development. #devices4kids #MedicalDevice pic.twitter.com/mzlmU6Nq9U (Source: Food and Drug Adminstration (FDA): CDRHNew)
Source: Food and Drug Adminstration (FDA): CDRHNew - August 13, 2018 Category: Medical Devices Authors: ( at FDADeviceInfo) Source Type: news

Highlights from today's Pediatric Medical Device Development Public Meeting: Bakul Patel discussed #digitalhealth and how technology enables development and access to safe medical devices #devices4kids #FDAPreCertpic.twitter.com/X4wQbX0Tjc
Highlights from today's Pediatric Medical Device Development Public Meeting: Bakul Patel discussed #digitalhealth and how technology enables development and access to safe medical devices #devices4kids #FDAPreCert pic.twitter.com/X4wQbX0Tjc (Source: Food and Drug Adminstration (FDA): CDRHNew)
Source: Food and Drug Adminstration (FDA): CDRHNew - August 13, 2018 Category: Medical Devices Authors: ( at FDADeviceInfo) Source Type: news

Today is Day 1 of the Pediatric Medical Device Development Public Meeting. Today we will discuss the programs, policies, and procedures at the #FDA intended to streamline evidence generation. https://go.usa.gov/xU6rg   #devices4kids #Pediatricspic.twitter.com/3tXTgwPJPo
Today is Day 1 of the Pediatric Medical Device Development Public Meeting. Today we will discuss the programs, policies, and procedures at the #FDA intended to streamline evidence generation. https://go.usa.gov/xU6rg  #devices4kids #Pediatrics pic.twitter.com/3tXTgwPJPo (Source: Food and Drug Adminstration (FDA): CDRHNew)
Source: Food and Drug Adminstration (FDA): CDRHNew - August 13, 2018 Category: Medical Devices Authors: ( at FDADeviceInfo) Source Type: news

Day 1 of the Pediatric Medical Device Public Meeting, today we be discussing about the National Evaluation System for health Technology , and incorporating Real-World Evidence generation strategies into #medicaldevice development for #pediatrics. https://go.usa.gov/xUvKR   pic.twitter.com/6KusScpBfI
Day 1 of the Pediatric Medical Device Public Meeting, today we be discussing about the National Evaluation System for health Technology , and incorporating Real-World Evidence generation strategies into #medicaldevice development for #pediatrics. https://go.usa.gov/xUvKR  pic.twitter.com/6KusScpBfI (Source: Food and Drug Adminstration (FDA): CDRHNew)
Source: Food and Drug Adminstration (FDA): CDRHNew - August 13, 2018 Category: Medical Devices Authors: ( at FDADeviceInfo) Source Type: news

Arkon Anesthesia Delivery System recalled due to unexpected failed state while in use or idle https://go.usa.gov/xUHbw   #fda #medicaldevice
Arkon Anesthesia Delivery System recalled due to unexpected failed state while in use or idle https://go.usa.gov/xUHbw  #fda #medicaldevice (Source: Food and Drug Adminstration (FDA): CDRHNew)
Source: Food and Drug Adminstration (FDA): CDRHNew - August 10, 2018 Category: Medical Devices Authors: ( at FDADeviceInfo) Source Type: news

Vyaire Medical, Inc. Recalls AirLife Resuscitation Devices Due to Manufacturing Error Preventing Oxygen Delivery https://go.usa.gov/xUHgr   #fda #medicaldevice
Vyaire Medical, Inc. Recalls AirLife Resuscitation Devices Due to Manufacturing Error Preventing Oxygen Delivery https://go.usa.gov/xUHgr  #fda #medicaldevice (Source: Food and Drug Adminstration (FDA): CDRHNew)
Source: Food and Drug Adminstration (FDA): CDRHNew - August 10, 2018 Category: Medical Devices Authors: ( at FDADeviceInfo) Source Type: news

FDA allows marketing of first direct-to-consumer app for contraceptive use to prevent pregnancy https://go.usa.gov/xUHC6  
FDA allows marketing of first direct-to-consumer app for contraceptive use to prevent pregnancy https://go.usa.gov/xUHC6  (Source: Food and Drug Adminstration (FDA): CDRHNew)
Source: Food and Drug Adminstration (FDA): CDRHNew - August 10, 2018 Category: Medical Devices Authors: ( at FDAMedia) Source Type: news

Letter to Health Care Providers: Risks Associated with Use of Rupture of Membrane Tests https://go.usa.gov/xUAt4   #MedicalDevice #FDA
Letter to Health Care Providers: Risks Associated with Use of Rupture of Membrane Tests https://go.usa.gov/xUAt4  #MedicalDevice #FDA (Source: Food and Drug Adminstration (FDA): CDRHNew)
Source: Food and Drug Adminstration (FDA): CDRHNew - August 8, 2018 Category: Medical Devices Authors: ( at FDADeviceInfo) Source Type: news

The FDA ’ s Fresh Empire campaign illustrates tobacco prevention messages to multicultural youth in a novel and attention-grabbing way. Watch the new ad encouraging teens to live tobacco free: https://www.youtube.com/watch?v=6iBAMnU96UY   …
The FDA’s Fresh Empire campaign illustrates tobacco prevention messages to multicultural youth in a novel and attention-grabbing way. Watch the new ad encouraging teens to live tobacco free: https://www.youtube.com/watch?v=6iBAMnU96UY … (Source: Food and Drug Adminstration (FDA): CDRHNew)
Source: Food and Drug Adminstration (FDA): CDRHNew - August 8, 2018 Category: Medical Devices Authors: ( at FDATobacco) Source Type: news

By Aug. 10, all packages and advertisements for “ covered ” tobacco products (except for cigars and pipe tobacco) and roll-your-own/cigarette tobacco products must have the required nicotine warning statement. https://cards.twitter.com/cards/2m2m96/5xn98   …
By Aug. 10, all packages and advertisements for “covered” tobacco products (except for cigars and pipe tobacco) and roll-your-own/cigarette tobacco products must have the required nicotine warning statement. https://cards.twitter.com/cards/2m2m96/5xn98 … (Source: Food and Drug Adminstration (FDA): CDRHNew)
Source: Food and Drug Adminstration (FDA): CDRHNew - August 7, 2018 Category: Medical Devices Authors: ( at FDATobacco) Source Type: news

Today is the last day to register to attend the Pediatric Medical Device Development public meeting in person. Click the link to learn more and register. #Pediatrics #medicaldevice https://go.usa.gov/xUvBD   pic.twitter.com/mWuQWK9MLk
Today is the last day to register to attend the Pediatric Medical Device Development public meeting in person. Click the link to learn more and register. #Pediatrics #medicaldevice https://go.usa.gov/xUvBD  pic.twitter.com/mWuQWK9MLk (Source: Food and Drug Adminstration (FDA): CDRHNew)
Source: Food and Drug Adminstration (FDA): CDRHNew - August 6, 2018 Category: Medical Devices Authors: ( at FDADeviceInfo) Source Type: news

Students are showcasing their work at #FDA ’ s Annual Summer Student Scientific Poster Daypic.twitter.com/Oq6r1ywLuw
Students are showcasing their work at #FDA’s Annual Summer Student Scientific Poster Day pic.twitter.com/Oq6r1ywLuw (Source: Food and Drug Adminstration (FDA): CDRHNew)
Source: Food and Drug Adminstration (FDA): CDRHNew - August 1, 2018 Category: Medical Devices Authors: ( at FDADeviceInfo) Source Type: news

Today the #FDA is hosting the 2018 Annual Summer Student Scientific Poster Day. We support the next generation of regulatory scientists.pic.twitter.com/mVClAeXKFi
Today the #FDA is hosting the 2018 Annual Summer Student Scientific Poster Day. We support the next generation of regulatory scientists. pic.twitter.com/mVClAeXKFi (Source: Food and Drug Adminstration (FDA): CDRHNew)
Source: Food and Drug Adminstration (FDA): CDRHNew - August 1, 2018 Category: Medical Devices Authors: ( at FDADeviceInfo) Source Type: news

During the Pediatric Medical Device Development, public meeting, the #FDA will highlight pathways to encourage the development of medical devices for children. There is still time to register! Click the link to learn more. https://go.usa.gov/xUvBD   #Pediatrics #medicaldevicepic.twitter.com/UzKDyAyER5
During the Pediatric Medical Device Development, public meeting, the #FDA will highlight pathways to encourage the development of medical devices for children. There is still time to register! Click the link to learn more. https://go.usa.gov/xUvBD  #Pediatrics #medicaldevice pic.twitter.com/UzKDyAyER5 (Source: Food and Drug Adminstration (FDA): CDRHNew)
Source: Food and Drug Adminstration (FDA): CDRHNew - July 31, 2018 Category: Medical Devices Authors: ( at FDADeviceInfo) Source Type: news

The #FDA promotes timely access to safe and effective medical devices for all patients, and supports pathways for children to share equally in medical device innovation.
(Source: Food and Drug Adminstration (FDA): CDRHNew)
Source: Food and Drug Adminstration (FDA): CDRHNew - July 31, 2018 Category: Medical Devices Authors: ( at FDADeviceInfo) Source Type: news

Join us for the Pediatric Medical Device Development public meeting Aug 13-14 to identify ways to increase the availability of medical devices for children. https://go.usa.gov/xUvBD   #Pediatrics #medicaldevicepic.twitter.com/ZP3ImzNw2T
Join us for the Pediatric Medical Device Development public meeting Aug 13-14 to identify ways to increase the availability of medical devices for children. https://go.usa.gov/xUvBD  #Pediatrics #medicaldevice pic.twitter.com/ZP3ImzNw2T (Source: Food and Drug Adminstration (FDA): CDRHNew)
Source: Food and Drug Adminstration (FDA): CDRHNew - July 31, 2018 Category: Medical Devices Authors: ( at FDADeviceInfo) Source Type: news

FDA ’ s Pediatric Device Consortia Grant Program (PDC) facilitates the development, of medical devices for children. 18 pediatric medical devices have been approved/cleared to date. Learn more about the PDC here: https://go.usa.gov/xUvBC   #Pediatrics #MedicalDevice #FDApic.twitter.com/HgMSCIbmra
FDA’s Pediatric Device Consortia Grant Program (PDC) facilitates the development, of medical devices for children. 18 pediatric medical devices have been approved/cleared to date. Learn more about the PDC here: https://go.usa.gov/xUvBC  #Pediatrics #MedicalDevice #FDA pic.twitter.com/HgMSCIbmra (Source: Food and Drug Adminstration (FDA): CDRHNew)
Source: Food and Drug Adminstration (FDA): CDRHNew - July 31, 2018 Category: Medical Devices Authors: ( at FDADeviceInfo) Source Type: news

Many medical devices for children may be approved by the Humanitarian Device Exemption pathway. Learn how the Humanitarian Device Exemption pathway program & other pathways can bring more devices intended for children to market. http://go.usa.gov/xUvZ7   #Pediatrics #medicaldevicepic.twitter.com/LEaSk1efJ5
Many medical devices for children may be approved by the Humanitarian Device Exemption pathway. Learn how the Humanitarian Device Exemption pathway program & other pathways can bring more devices intended for children to market. http://go.usa.gov/xUvZ7  #Pediatrics #medicaldevice pic.twitter.com/LEaSk1efJ5 (Source: Food and Drug Adminstration (FDA): CDRHNew)
Source: Food and Drug Adminstration (FDA): CDRHNew - July 31, 2018 Category: Medical Devices Authors: ( at FDADeviceInfo) Source Type: news

On Aug 13-14, the #FDA is hosting the Pediatric Medical Device Development public meeting at the White Oak campus. Join us and participate in discussions around increasing medical device development for children. More info here: https://go.usa.gov/xUvZm   #Pediatrics #medicaldevicepic.twitter.com/c0cuVYtTLK
On Aug 13-14, the #FDA is hosting the Pediatric Medical Device Development public meeting at the White Oak campus. Join us and participate in discussions around increasing medical device development for children. More info here: https://go.usa.gov/xUvZm  #Pediatrics #medicaldevice pic.twitter.com/c0cuVYtTLK (Source: Food and Drug Adminstration (FDA): CDRHNew)
Source: Food and Drug Adminstration (FDA): CDRHNew - July 31, 2018 Category: Medical Devices Authors: ( at FDADeviceInfo) Source Type: news

#FDA Warns Against Use of Energy-Based Devices to Perform Vaginal “ Rejuvenation ” or Vaginal Cosmetic Procedures http://go.usa.gov/xUdgB   #MedicalDevice
#FDA Warns Against Use of Energy-Based Devices to Perform Vaginal “Rejuvenation” or Vaginal Cosmetic Procedures http://go.usa.gov/xUdgB  #MedicalDevice (Source: Food and Drug Adminstration (FDA): CDRHNew)
Source: Food and Drug Adminstration (FDA): CDRHNew - July 30, 2018 Category: Medical Devices Authors: ( at FDADeviceInfo) Source Type: news

#FDA shows more examples of cleared Mobile Medical Apps https://go.usa.gov/xUEPf   #DigitalHealth #mhealth #HealthTech #MedicalDevice
#FDA shows more examples of cleared Mobile Medical Apps https://go.usa.gov/xUEPf  #DigitalHealth #mhealth #HealthTech #MedicalDevice (Source: Food and Drug Adminstration (FDA): CDRHNew)
Source: Food and Drug Adminstration (FDA): CDRHNew - July 25, 2018 Category: Medical Devices Authors: ( at FDADeviceInfo) Source Type: news

#FDA issues updated safety communication for Zoll LifeVest 4000 regarding “ Message Code 102, ” and updated patient checklist. https://go.usa.gov/xUEPn   #MedicalDevices
#FDA issues updated safety communication for Zoll LifeVest 4000 regarding “Message Code 102,” and updated patient checklist. https://go.usa.gov/xUEPn  #MedicalDevices (Source: Food and Drug Adminstration (FDA): CDRHNew)
Source: Food and Drug Adminstration (FDA): CDRHNew - July 25, 2018 Category: Medical Devices Authors: ( at FDADeviceInfo) Source Type: news

Even when Essure is no longer sold, the #FDA will remain vigilant in protecting patients who ’ ve already had this device implanted. We ’ ll continue to monitor adverse events and publicly communicate any new safety findings on this - and any other device. https://www.bloomberg.com/news/articles/2018-07-20/bayer-to-stop-selling-contraceptive-implant-after-threats-by-fda   …
Even when Essure is no longer sold, the #FDA will remain vigilant in protecting patients who’ve already had this device implanted. We’ll continue to monitor adverse events and publicly communicate any new safety findings on this - and any other device. https://www.bloomberg.com/news/articles/2018-07-20/bayer-to-stop-selling-contraceptive-implant-after-threats-by-fda … (Source: Food and Drug Adminstration (FDA): CDRHNew)
Source: Food and Drug Adminstration (FDA): CDRHNew - July 22, 2018 Category: Medical Devices Authors: ( at SGottliebFDA) Source Type: news

As the #FDA learned more from patients about the serious adverse events associated with this device, we took a series of important actions to better understand the benefits and risks, and to address patient safety concerns. https://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm614123.htm   …
As the #FDA learned more from patients about the serious adverse events associated with this device, we took a series of important actions to better understand the benefits and risks, and to address patient safety concerns. https://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm614123.htm … (Source: Food and Drug Adminstration (FDA): CDRHNew)
Source: Food and Drug Adminstration (FDA): CDRHNew - July 22, 2018 Category: Medical Devices Authors: ( at SGottliebFDA) Source Type: news

On Friday, Bayer said the permanent birth control device Essure would no longer be sold or distributed in the US for commercial reasons after 12/31/18. This came after FDA ’ s patient safety action in April restricting sale and distribution of the device and earlier agency actions
On Friday, Bayer said the permanent birth control device Essure would no longer be sold or distributed in the US for commercial reasons after 12/31/18. This came after FDA’s patient safety action in April restricting sale and distribution of the device and earlier agency actions (Source: Food and Drug Adminstration (FDA): CDRHNew)
Source: Food and Drug Adminstration (FDA): CDRHNew - July 22, 2018 Category: Medical Devices Authors: ( at SGottliebFDA) Source Type: news

Medical device safety is a key #FDA priority. We ’ re committed to protecting U.S. patients by minimizing avoidable risks, assuring they have timely information to make well-informed decisions, and advancing devices that are safer, more effective, and address unmet medical need.pic.twitter.com/Dm73SQ213p
Medical device safety is a key #FDA priority. We’re committed to protecting U.S. patients by minimizing avoidable risks, assuring they have timely information to make well-informed decisions, and advancing devices that are safer, more effective, and address unmet medical need. pic.twitter.com/Dm73SQ213p (Source: Food and Drug Adminstration (FDA): CDRHNew)
Source: Food and Drug Adminstration (FDA): CDRHNew - July 22, 2018 Category: Medical Devices Authors: ( at SGottliebFDA) Source Type: news

Our aim: ensure that devices not only meet the gold standard for getting to market but continue to meet this standard as we get more data and learn more about their benefit-risk profile in real-world settings. These new approaches will also help advance beneficial innovation
(Source: Food and Drug Adminstration (FDA): CDRHNew)
Source: Food and Drug Adminstration (FDA): CDRHNew - July 22, 2018 Category: Medical Devices Authors: ( at SGottliebFDA) Source Type: news

We'll integrate #FDA ’ s premarket and post-market activities through a reorganization in our medical device centers, creating a broader and deeper view of device safety, effectiveness and quality across the total product life cycle. Patient Safety is at the center of these effortspic.twitter.com/msK4BH9BPQ
We'll integrate #FDA’s premarket and post-market activities through a reorganization in our medical device centers, creating a broader and deeper view of device safety, effectiveness and quality across the total product life cycle. Patient Safety is at the center of these efforts pic.twitter.com/msK4BH9BPQ (Source: Food and Drug Adminstration (FDA): CDRHNew)
Source: Food and Drug Adminstration (FDA): CDRHNew - July 22, 2018 Category: Medical Devices Authors: ( at SGottliebFDA) Source Type: news

Among our efforts, one approach: the possible development of a public-private partnership – a CyberMed Safety Analysis Board - to complement existing device vulnerability and response mechanisms and serve as a resource for device makers and #FDA
Among our efforts, one approach: the possible development of a public-private partnership – a CyberMed Safety Analysis Board - to complement existing device vulnerability and response mechanisms and serve as a resource for device makers and #FDA (Source: Food and Drug Adminstration (FDA): CDRHNew)
Source: Food and Drug Adminstration (FDA): CDRHNew - July 22, 2018 Category: Medical Devices Authors: ( at SGottliebFDA) Source Type: news

We will advance medical device cybersecurity to keep pace with emerging threats and vulnerabilities. This includes updating premarket guidance and considering new post-market authority. We'll have an announcement soon on major new policy.pic.twitter.com/tzZKxpQbmx
We will advance medical device cybersecurity to keep pace with emerging threats and vulnerabilities. This includes updating premarket guidance and considering new post-market authority. We'll have an announcement soon on major new policy. pic.twitter.com/tzZKxpQbmx (Source: Food and Drug Adminstration (FDA): CDRHNew)
Source: Food and Drug Adminstration (FDA): CDRHNew - July 22, 2018 Category: Medical Devices Authors: ( at SGottliebFDA) Source Type: news

But predicates may be decades old. Our new “ expanded abbreviated ” 510(k) path to market https://bit.ly/2vnc1Zl   may drive greater market competition for safer devices. It explains how objective performance criteria may be used to demonstrate substantial equivalence.
But predicates may be decades old. Our new “expanded abbreviated” 510(k) path to market https://bit.ly/2vnc1Zl  may drive greater market competition for safer devices. It explains how objective performance criteria may be used to demonstrate substantial equivalence. (Source: Food and Drug Adminstration (FDA): CDRHNew)
Source: Food and Drug Adminstration (FDA): CDRHNew - July 22, 2018 Category: Medical Devices Authors: ( at SGottliebFDA) Source Type: news

Some devices come to market after #FDA determines that they're substantially equivalent to another legally marketed device called the predicate – this is the 510(k) pathway typically used for moderate risk devices.
Some devices come to market after #FDA determines that they're substantially equivalent to another legally marketed device called the predicate – this is the 510(k) pathway typically used for moderate risk devices. (Source: Food and Drug Adminstration (FDA): CDRHNew)
Source: Food and Drug Adminstration (FDA): CDRHNew - July 22, 2018 Category: Medical Devices Authors: ( at SGottliebFDA) Source Type: news

We ’ re exploring ways to use umbrella regulation or seek authority to address new risks faster. We're pursuing ways to spur innovation in safer devices; creating a Breakthrough Devices-like path https://bit.ly/2O43EqH   and providing streamlined paths for comparative safety claimspic.twitter.com/30wLydOAec
We’re exploring ways to use umbrella regulation or seek authority to address new risks faster. We're pursuing ways to spur innovation in safer devices; creating a Breakthrough Devices-like path https://bit.ly/2O43EqH  and providing streamlined paths for comparative safety claims pic.twitter.com/30wLydOAec (Source: Food and Drug Adminstration (FDA): CDRHNew)
Source: Food and Drug Adminstration (FDA): CDRHNew - July 22, 2018 Category: Medical Devices Authors: ( at SGottliebFDA) Source Type: news

We'll consider regulatory options to speed up requiring companies to mitigate safety problems identified postmarket. Currently, mitigations such as new user training or new labeling can require rulemaking, which takes time and resources
(Source: Food and Drug Adminstration (FDA): CDRHNew)
Source: Food and Drug Adminstration (FDA): CDRHNew - July 22, 2018 Category: Medical Devices Authors: ( at SGottliebFDA) Source Type: news

We must address data gaps on tech for women ’ s health. Our new Women ’ s Health Technologies Strategically Coordinated Registry Network https://bit.ly/2L4Tqsx   provides more evidence on areas as uterine fibroids, pelvic floor disorders & female long-acting reversible contraceptionpic.twitter.com/TAWmVh99oL
We must address data gaps on tech for women’s health. Our new Women’s Health Technologies Strategically Coordinated Registry Network https://bit.ly/2L4Tqsx  provides more evidence on areas as uterine fibroids, pelvic floor disorders & female long-acting reversible contraception pic.twitter.com/TAWmVh99oL (Source: Food and Drug Adminstration (FDA): CDRHNew)
Source: Food and Drug Adminstration (FDA): CDRHNew - July 22, 2018 Category: Medical Devices Authors: ( at SGottliebFDA) Source Type: news

NEST will facilitate timely detection of potential safety risks that wouldn ’ t otherwise be identified as quickly, or at all. But it requires addressing variations in data standards and ensuring systems talk to each other
NEST will facilitate timely detection of potential safety risks that wouldn’t otherwise be identified as quickly, or at all. But it requires addressing variations in data standards and ensuring systems talk to each other (Source: Food and Drug Adminstration (FDA): CDRHNew)
Source: Food and Drug Adminstration (FDA): CDRHNew - July 22, 2018 Category: Medical Devices Authors: ( at SGottliebFDA) Source Type: news

We'll establish a robust medical device patient safety net by continuing our work on NEST, or the National Evaluation System for health Technology. NEST links data from registries, EHRs and billing claimspic.twitter.com/m2UaZ6gEaV
We'll establish a robust medical device patient safety net by continuing our work on NEST, or the National Evaluation System for health Technology. NEST links data from registries, EHRs and billing claims pic.twitter.com/m2UaZ6gEaV (Source: Food and Drug Adminstration (FDA): CDRHNew)
Source: Food and Drug Adminstration (FDA): CDRHNew - July 22, 2018 Category: Medical Devices Authors: ( at SGottliebFDA) Source Type: news

The Medical Device Safety Action Plan focuses on five key areas: establishing a safety net, exploring regulatory options, spurring Innovation, advancing cybersecurity and advancing the Total Product Lifecycle approach to Device Safety. Let ’ s look at each areapic.twitter.com/aDwVxKGjyA
The Medical Device Safety Action Plan focuses on five key areas: establishing a safety net, exploring regulatory options, spurring Innovation, advancing cybersecurity and advancing the Total Product Lifecycle approach to Device Safety. Let’s look at each area pic.twitter.com/aDwVxKGjyA (Source: Food and Drug Adminstration (FDA): CDRHNew)
Source: Food and Drug Adminstration (FDA): CDRHNew - July 22, 2018 Category: Medical Devices Authors: ( at SGottliebFDA) Source Type: news

I, along with my CDRH colleagues, recently unveiled #FDA ’ s Medical Device Safety Action Plan https://bit.ly/2Hpc3l9   that builds on these substantial efforts, and reflects the dedication & expertise of #FDA professional staff to these issuespic.twitter.com/8NkA9VzKM4
I, along with my CDRH colleagues, recently unveiled #FDA’s Medical Device Safety Action Plan https://bit.ly/2Hpc3l9  that builds on these substantial efforts, and reflects the dedication & expertise of #FDA professional staff to these issues pic.twitter.com/8NkA9VzKM4 (Source: Food and Drug Adminstration (FDA): CDRHNew)
Source: Food and Drug Adminstration (FDA): CDRHNew - July 22, 2018 Category: Medical Devices Authors: ( at SGottliebFDA) Source Type: news

To further enhance device safety, we've required that labels/packages of most devices include unique device identifiers (UDIs) to better track a device & have been laying groundwork for using real-world evidence from electronic health records, medical claims & device registriespic.twitter.com/e5BxqXYJbB
To further enhance device safety, we've required that labels/packages of most devices include unique device identifiers (UDIs) to better track a device & have been laying groundwork for using real-world evidence from electronic health records, medical claims & device registries pic.twitter.com/e5BxqXYJbB (Source: Food and Drug Adminstration (FDA): CDRHNew)
Source: Food and Drug Adminstration (FDA): CDRHNew - July 22, 2018 Category: Medical Devices Authors: ( at SGottliebFDA) Source Type: news

Once on market, #FDA monitors for safety issues by collecting adverse event reports https://bit.ly/2mlhQ20   , reviewing published studies, ordering postmarket studies and inspecting facilities. We want to build on limits of these tools, as they don ’ t provide real-time informationpic.twitter.com/WJMYVcAyoQ
Once on market, #FDA monitors for safety issues by collecting adverse event reports https://bit.ly/2mlhQ20 , reviewing published studies, ordering postmarket studies and inspecting facilities. We want to build on limits of these tools, as they don’t provide real-time information pic.twitter.com/WJMYVcAyoQ (Source: Food and Drug Adminstration (FDA): CDRHNew)
Source: Food and Drug Adminstration (FDA): CDRHNew - July 22, 2018 Category: Medical Devices Authors: ( at SGottliebFDA) Source Type: news

#FDA thoroughly evaluates risks and the potential for user error before a device is cleared or approved for marketing. But we know that not everything can be revealed and known about a device before it reaches the market
(Source: Food and Drug Adminstration (FDA): CDRHNew)
Source: Food and Drug Adminstration (FDA): CDRHNew - July 22, 2018 Category: Medical Devices Authors: ( at SGottliebFDA) Source Type: news

Bayer to stop #Essure sales in the U.S. https://go.usa.gov/xUnaA   #MedicalDevice
Bayer to stop #Essure sales in the U.S. https://go.usa.gov/xUnaA  #MedicalDevice (Source: Food and Drug Adminstration (FDA): CDRHNew)
Source: Food and Drug Adminstration (FDA): CDRHNew - July 20, 2018 Category: Medical Devices Authors: ( at FDADeviceInfo) Source Type: news