#FDA In Brief: @US_FDA takes steps to advance the safety and accuracy of blood glucose monitors to empower patients with diabetes with reliable tools to manage their health. Read more: https://go.usa.gov/xPMyA   #MedicalDevice
#FDA In Brief: @US_FDA takes steps to advance the safety and accuracy of blood glucose monitors to empower patients with diabetes with reliable tools to manage their health. Read more: https://go.usa.gov/xPMyA  #MedicalDevice (Source: Food and Drug Adminstration (FDA): CDRHNew)
Source: Food and Drug Adminstration (FDA): CDRHNew - November 30, 2018 Category: Medical Devices Authors: ( at FDADeviceInfo) Source Type: news

.@US_FDA issues class I recall, the most serious type pf recall: Synaptive Medical Recalls BrightMatter Guide with SurfaceTrace Registration Due to Software Defect. Read more about the recall: https://go.usa.gov/xPMEn   #MedicalDevicepic.twitter.com/YU9Iq3Yw0b
. @US_FDA issues class I recall, the most serious type pf recall: Synaptive Medical Recalls BrightMatter Guide with SurfaceTrace Registration Due to Software Defect. Read more about the recall: https://go.usa.gov/xPMEn  #MedicalDevice pic.twitter.com/YU9Iq3Yw0b (Source: Food and Drug Adminstration (FDA): CDRHNew)
Source: Food and Drug Adminstration (FDA): CDRHNew - November 30, 2018 Category: Medical Devices Authors: ( at FDADeviceInfo) Source Type: news

.@US_FDA issues class I recall, the most serious type pf recall: Zimmer Biomet, Inc. Recalls Spinal Fusion & Long Bone Stimulators Due to Lack of Adequate Validation and Controls to Ensure Product Cleanliness. Read more about the recall: https://go.usa.gov/xPMEK   #MedicalDevicepic.twitter.com/M55ddC98wW
. @US_FDA issues class I recall, the most serious type pf recall: Zimmer Biomet, Inc. Recalls Spinal Fusion & Long Bone Stimulators Due to Lack of Adequate Validation and Controls to Ensure Product Cleanliness. Read more about the recall: https://go.usa.gov/xPMEK  #MedicalDevice pic.twitter.com/M55ddC98wW (Source: Food and Drug Adminstration (FDA): CDRHNew)
Source: Food and Drug Adminstration (FDA): CDRHNew - November 30, 2018 Category: Medical Devices Authors: ( at FDADeviceInfo) Source Type: news

Selected participants will work directly with the FDA to accelerate the development of and eventual review of marketing applications for these innovative products. Read more: https://go.usa.gov/xPMPk   pic.twitter.com/6rRnfSyLy4
Selected participants will work directly with the FDA to accelerate the development of and eventual review of marketing applications for these innovative products. Read more: https://go.usa.gov/xPMPk  pic.twitter.com/6rRnfSyLy4 (Source: Food and Drug Adminstration (FDA): CDRHNew)
Source: Food and Drug Adminstration (FDA): CDRHNew - November 30, 2018 Category: Medical Devices Authors: ( at FDADeviceInfo) Source Type: news

.@US_FDA has selected 8 novel medical devices as participants in #FDA ’ s Innovation Challenge to address the #OpioidEpidemic by preventing and treating opioid use disorder. #FDAInnovationChallenge
. @US_FDA has selected 8 novel medical devices as participants in #FDA’s Innovation Challenge to address the #OpioidEpidemic by preventing and treating opioid use disorder. #FDAInnovationChallenge (Source: Food and Drug Adminstration (FDA): CDRHNew)
Source: Food and Drug Adminstration (FDA): CDRHNew - November 30, 2018 Category: Medical Devices Authors: ( at FDADeviceInfo) Source Type: news

#DYK November is #NationalHealthySkinMonth. Are you thinking about getting Dermal Fillers? Check out the @US_FDA's information on Dermal Fillers before you do: https://go.usa.gov/xPHtk   #FDA #MedicalDevice
#DYK November is #NationalHealthySkinMonth. Are you thinking about getting Dermal Fillers? Check out the @US_FDA's information on Dermal Fillers before you do: https://go.usa.gov/xPHtk  #FDA #MedicalDevice (Source: Food and Drug Adminstration (FDA): CDRHNew)
Source: Food and Drug Adminstration (FDA): CDRHNew - November 26, 2018 Category: Medical Devices Authors: ( at FDADeviceInfo) Source Type: news

We aim to efficiently advance beneficial technology to patients, while solidifying FDA ’ s gold standard for safety. Our goal in focusing on older predicates is to drive sponsors to continually offer patients devices with the latest demonstrated improvements and advances in safety.
We aim to efficiently advance beneficial technology to patients, while solidifying FDA’s gold standard for safety. Our goal in focusing on older predicates is to drive sponsors to continually offer patients devices with the latest demonstrated improvements and advances in safety. (Source: Food and Drug Adminstration (FDA): CDRHNew)
Source: Food and Drug Adminstration (FDA): CDRHNew - November 26, 2018 Category: Medical Devices Authors: ( at SGottliebFDA) Source Type: news

It would also help make sure that newer devices reflect more modern technologies and standards that can improve patient care and outcomes. It would help the overall product environment continue to evolve in the direction toward safer, more effective devices.
(Source: Food and Drug Adminstration (FDA): CDRHNew)
Source: Food and Drug Adminstration (FDA): CDRHNew - November 26, 2018 Category: Medical Devices Authors: ( at SGottliebFDA) Source Type: news

We believe that encouraging product developers to use more modern predicates would give patients and their doctors a choice among older and newer versions of a type of device while promoting greater competition to adopt modern features that improve safety and performance.
(Source: Food and Drug Adminstration (FDA): CDRHNew)
Source: Food and Drug Adminstration (FDA): CDRHNew - November 26, 2018 Category: Medical Devices Authors: ( at SGottliebFDA) Source Type: news

In the next few months CDRH will make public on its website cleared devices that demonstrated substantial equivalence to older predicate devices. We ’ re considering focusing on predicates that are > 10 years old as a starting point, so the public is aware of those technologies.
In the next few months CDRH will make public on its website cleared devices that demonstrated substantial equivalence to older predicate devices. We’re considering focusing on predicates that are>10 years old as a starting point, so the public is aware of those technologies. (Source: Food and Drug Adminstration (FDA): CDRHNew)
Source: Food and Drug Adminstration (FDA): CDRHNew - November 26, 2018 Category: Medical Devices Authors: ( at SGottliebFDA) Source Type: news

These examples help illustrate why we believe that newer devices should be compared to the benefits and risks of more modern technologies and why we ’ re looking at ways to promote the use of more recent predicates
These examples help illustrate why we believe that newer devices should be compared to the benefits and risks of more modern technologies and why we’re looking at ways to promote the use of more recent predicates (Source: Food and Drug Adminstration (FDA): CDRHNew)
Source: Food and Drug Adminstration (FDA): CDRHNew - November 26, 2018 Category: Medical Devices Authors: ( at SGottliebFDA) Source Type: news

A stereotactic system used by neurosurgeons to more precisely determine where to perform their surgical procedure was intended to be MRI compatible but the older predicate it compared itself to was not, requiring additional performance testing.
(Source: Food and Drug Adminstration (FDA): CDRHNew)
Source: Food and Drug Adminstration (FDA): CDRHNew - November 26, 2018 Category: Medical Devices Authors: ( at SGottliebFDA) Source Type: news

An infusion pump whose predicate device uses older “ beam break ” technology to estimate the size of the drop. The new device uses a video camera and vision processing to monitor the drop formation and detect drops falling, making the device more precise and more accurate.
An infusion pump whose predicate device uses older “beam break” technology to estimate the size of the drop. The new device uses a video camera and vision processing to monitor the drop formation and detect drops falling, making the device more precise and more accurate. (Source: Food and Drug Adminstration (FDA): CDRHNew)
Source: Food and Drug Adminstration (FDA): CDRHNew - November 26, 2018 Category: Medical Devices Authors: ( at SGottliebFDA) Source Type: news

An X-ray system that includes a controller to control time of x-ray exposure. These new devices now meet performance standards and consensus standards that were either not available or have been revised to meet more modern criteria since the predicate device was cleared
(Source: Food and Drug Adminstration (FDA): CDRHNew)
Source: Food and Drug Adminstration (FDA): CDRHNew - November 26, 2018 Category: Medical Devices Authors: ( at SGottliebFDA) Source Type: news

A hemodialysis system, which has modernized through miniaturization; and a patient monitoring system that can monitor more patients and/or more parameters and which are increasingly becoming networked in healthcare facilities increasing the risk for cybersecurity threats.
(Source: Food and Drug Adminstration (FDA): CDRHNew)
Source: Food and Drug Adminstration (FDA): CDRHNew - November 26, 2018 Category: Medical Devices Authors: ( at SGottliebFDA) Source Type: news

Following are some examples of devices that have been modernized over the past several years, but for which some manufacturers have relied on older predicates:
(Source: Food and Drug Adminstration (FDA): CDRHNew)
Source: Food and Drug Adminstration (FDA): CDRHNew - November 26, 2018 Category: Medical Devices Authors: ( at SGottliebFDA) Source Type: news

Data show that nearly 20% of current 510(k)s are cleared based on a predicate that ’ s more than 10 years old. That doesn ’ t mean the products are unsafe. But it does mean that some devices may not be continually improving, which is the hallmark of health technologies.
Data show that nearly 20% of current 510(k)s are cleared based on a predicate that’s more than 10 years old. That doesn’t mean the products are unsafe. But it does mean that some devices may not be continually improving, which is the hallmark of health technologies. (Source: Food and Drug Adminstration (FDA): CDRHNew)
Source: Food and Drug Adminstration (FDA): CDRHNew - November 26, 2018 Category: Medical Devices Authors: ( at SGottliebFDA) Source Type: news

In 510(k), manufacturers often rely on comparative testing vs predicate devices to show a new device is as safe and effective as the predicate. But older predicates might not closely reflect the modern tech embedded in new devices or more current understanding of benefits & risks
In 510(k), manufacturers often rely on comparative testing vs predicate devices to show a new device is as safe and effective as the predicate. But older predicates might not closely reflect the modern tech embedded in new devices or more current understanding of benefits & risks (Source: Food and Drug Adminstration (FDA): CDRHNew)
Source: Food and Drug Adminstration (FDA): CDRHNew - November 26, 2018 Category: Medical Devices Authors: ( at SGottliebFDA) Source Type: news

We believe in merits of 510(k) process, but also believe it must be modernized to reflect advances in technology, safety, capabilities of newer devices. It ’ s time to fundamentally modernize an approach first adopted in 1976 c/w Medical Device Safety Action we issued in April 2018
We believe in merits of 510(k) process, but also believe it must be modernized to reflect advances in technology, safety, capabilities of newer devices. It’s time to fundamentally modernize an approach first adopted in 1976 c/w Medical Device Safety Action we issued in April 2018 (Source: Food and Drug Adminstration (FDA): CDRHNew)
Source: Food and Drug Adminstration (FDA): CDRHNew - November 26, 2018 Category: Medical Devices Authors: ( at SGottliebFDA) Source Type: news

The 510(k) program has been strengthened and refined in many ways, especially in recent years, as the FDA ’ s Device Center has made a systematic, concerted effort to improve the program ’ s performance, predictability, efficiency and safety.
The 510(k) program has been strengthened and refined in many ways, especially in recent years, as the FDA’s Device Center has made a systematic, concerted effort to improve the program’s performance, predictability, efficiency and safety. (Source: Food and Drug Adminstration (FDA): CDRHNew)
Source: Food and Drug Adminstration (FDA): CDRHNew - November 26, 2018 Category: Medical Devices Authors: ( at SGottliebFDA) Source Type: news

TWEETORIAL: Today we announced changes to modernize FDA ’ s 510(k) clearance pathway, used for clearance of low- to moderate-risk devices that are substantially equivalent to a device already on the market, known as a predicate device https://go.usa.gov/xPHdE  
TWEETORIAL: Today we announced changes to modernize FDA’s 510(k) clearance pathway, used for clearance of low- to moderate-risk devices that are substantially equivalent to a device already on the market, known as a predicate device https://go.usa.gov/xPHdE  (Source: Food and Drug Adminstration (FDA): CDRHNew)
Source: Food and Drug Adminstration (FDA): CDRHNew - November 26, 2018 Category: Medical Devices Authors: ( at SGottliebFDA) Source Type: news

Today #FDA announced the most significant modernization of the 510(k) medical device review process in a generation. https://www.wsj.com/articles/fda-is-revamping-clearance-procedures-for-medical-devices-1543234015   …
Today #FDA announced the most significant modernization of the 510(k) medical device review process in a generation. https://www.wsj.com/articles/fda-is-revamping-clearance-procedures-for-medical-devices-1543234015 … (Source: Food and Drug Adminstration (FDA): CDRHNew)
Source: Food and Drug Adminstration (FDA): CDRHNew - November 26, 2018 Category: Medical Devices Authors: ( at SGottliebFDA) Source Type: news

Today ’ s statement highlights increased expectations for information required in 510(k) submissions; each averages 1,185 pages, compared to 475 pages in 2009. Reviewers spend more time reviewing applications, but time to decision has become more efficient https://go.usa.gov/xPHdE  
Today’s statement highlights increased expectations for information required in 510(k) submissions; each averages 1,185 pages, compared to 475 pages in 2009. Reviewers spend more time reviewing applications, but time to decision has become more efficient https://go.usa.gov/xPHdE  (Source: Food and Drug Adminstration (FDA): CDRHNew)
Source: Food and Drug Adminstration (FDA): CDRHNew - November 26, 2018 Category: Medical Devices Authors: ( at SGottliebFDA) Source Type: news

Today, #FDA ’ s device center also posted performance report highlighting measures taken to increase predictability, transparency of 510(k) review process, incl. 50 final guidance documents on important medical device policy issues issued since 2009. https://go.usa.gov/xPHdn  
Today, #FDA’s device center also posted performance report highlighting measures taken to increase predictability, transparency of 510(k) review process, incl. 50 final guidance documents on important medical device policy issues issued since 2009. https://go.usa.gov/xPHdn  (Source: Food and Drug Adminstration (FDA): CDRHNew)
Source: Food and Drug Adminstration (FDA): CDRHNew - November 26, 2018 Category: Medical Devices Authors: ( at SGottliebFDA) Source Type: news

As device technology evolves and becomes increasingly complex, #FDA needs to keep pace. Our proposed changes to the 510(k) clearance pathway will allow FDA to retire outdated predicates and use new technologies to promote innovation and improved safety. https://go.usa.gov/xPHdE  
As device technology evolves and becomes increasingly complex, #FDA needs to keep pace. Our proposed changes to the 510(k) clearance pathway will allow FDA to retire outdated predicates and use new technologies to promote innovation and improved safety. https://go.usa.gov/xPHdE  (Source: Food and Drug Adminstration (FDA): CDRHNew)
Source: Food and Drug Adminstration (FDA): CDRHNew - November 26, 2018 Category: Medical Devices Authors: ( at SGottliebFDA) Source Type: news

.@US_FDA issues Class I Medical Device Recall, the most serious type of recall: Oscor Recalls TB Temporary Bipolar Pacing Leads Due to Connector Separation Causing Potential for Loss of Pacing. Find out more: https://go.usa.gov/xPHxF   #FDA #MedicalDevicepic.twitter.com/negJ6HU4x2
. @US_FDA issues Class I Medical Device Recall, the most serious type of recall: Oscor Recalls TB Temporary Bipolar Pacing Leads Due to Connector Separation Causing Potential for Loss of Pacing. Find out more: https://go.usa.gov/xPHxF  #FDA #MedicalDevice pic.twitter.com/negJ6HU4x2 (Source: Food and Drug Adminstration (FDA): CDRHNew)
Source: Food and Drug Adminstration (FDA): CDRHNew - November 23, 2018 Category: Medical Devices Authors: ( at FDADeviceInfo) Source Type: news

Presentations have been posted for the November 15, 2018 Patient Engagement Advisory Committee meeting. #PEAC2018 Read more: https://go.usa.gov/xPHxf   #FDA #MedicalDevice
Presentations have been posted for the November 15, 2018 Patient Engagement Advisory Committee meeting. #PEAC2018 Read more: https://go.usa.gov/xPHxf  #FDA #MedicalDevice (Source: Food and Drug Adminstration (FDA): CDRHNew)
Source: Food and Drug Adminstration (FDA): CDRHNew - November 23, 2018 Category: Medical Devices Authors: ( at FDADeviceInfo) Source Type: news

.@US_FDA issues update to safety communication warning against the use of energy-based devices to perform vaginal “ rejuvenation ” or vaginal cosmetic procedures. Read more: https://go.usa.gov/xPAzk   #MedicalDevicepic.twitter.com/pv0k2yaNfj
. @US_FDA issues update to safety communication warning against the use of energy-based devices to perform vaginal “rejuvenation” or vaginal cosmetic procedures. Read more: https://go.usa.gov/xPAzk  #MedicalDevice pic.twitter.com/pv0k2yaNfj (Source: Food and Drug Adminstration (FDA): CDRHNew)
Source: Food and Drug Adminstration (FDA): CDRHNew - November 20, 2018 Category: Medical Devices Authors: ( at FDADeviceInfo) Source Type: news

.@US_FDA has updated the webpage on Urogynecologic Surgical Mesh Implants. Read more: https://go.usa.gov/xPAzD   #MedicalDevice
. @US_FDA has updated the webpage on Urogynecologic Surgical Mesh Implants. Read more: https://go.usa.gov/xPAzD  #MedicalDevice (Source: Food and Drug Adminstration (FDA): CDRHNew)
Source: Food and Drug Adminstration (FDA): CDRHNew - November 20, 2018 Category: Medical Devices Authors: ( at FDADeviceInfo) Source Type: news

.@US_FDA issues Class I Medical Device Recall, the most serious type of recall: Beckman Coulter Life Sciences Beckman Coulter Life Sciences recalls the FC500 Series Flow Cytometers and EPICS XL Series Flow Cytometers. Find out more: https://go.usa.gov/xPAtn   #MedicalDevice #FDApic.twitter.com/6e064UQ2wg
. @US_FDA issues Class I Medical Device Recall, the most serious type of recall: Beckman Coulter Life Sciences Beckman Coulter Life Sciences recalls the FC500 Series Flow Cytometers and EPICS XL Series Flow Cytometers. Find out more: https://go.usa.gov/xPAtn  #MedicalDevice #FDA pic.twitter.com/6e064UQ2wg (Source: Food and Drug Adminstration (FDA): CDRHNew)
Source: Food and Drug Adminstration (FDA): CDRHNew - November 20, 2018 Category: Medical Devices Authors: ( at FDADeviceInfo) Source Type: news

#FDA has set important new goal when it comes to device safety: ensuring that we ’ re consistently first in the world to identify and act upon device safety signals to protect patients. https://go.usa.gov/xPAf7   pic.twitter.com/IATHeEUgHe
#FDA has set important new goal when it comes to device safety: ensuring that we’re consistently first in the world to identify and act upon device safety signals to protect patients. https://go.usa.gov/xPAf7  pic.twitter.com/IATHeEUgHe (Source: Food and Drug Adminstration (FDA): CDRHNew)
Source: Food and Drug Adminstration (FDA): CDRHNew - November 20, 2018 Category: Medical Devices Authors: ( at SGottliebFDA) Source Type: news

Are you traveling with some yummy food for #Thanksgiving this year? Take a few minutes to learn some #foodsafety tips to make sure you & your family don ’ t get sick. http://go.usa.gov/xPXzH   pic.twitter.com/tTpNUmwzcm
Are you traveling with some yummy food for #Thanksgiving this year? Take a few minutes to learn some #foodsafety tips to make sure you & your family don’t get sick. http://go.usa.gov/xPXzH  pic.twitter.com/tTpNUmwzcm (Source: Food and Drug Adminstration (FDA): CDRHNew)
Source: Food and Drug Adminstration (FDA): CDRHNew - November 20, 2018 Category: Medical Devices Authors: ( at SGottliebFDA) Source Type: news

School administrators/teachers share the vital mission of educating today's youth. Their guidance and leadership develops our young people into tomorrow's leaders. We hope these resources are helpful in getting students/educators talking about the risks of e-cigarette use.pic.twitter.com/v4YHpyORXl
School administrators/teachers share the vital mission of educating today's youth. Their guidance and leadership develops our young people into tomorrow's leaders. We hope these resources are helpful in getting students/educators talking about the risks of e-cigarette use. pic.twitter.com/v4YHpyORXl (Source: Food and Drug Adminstration (FDA): CDRHNew)
Source: Food and Drug Adminstration (FDA): CDRHNew - November 20, 2018 Category: Medical Devices Authors: ( at SGottliebFDA) Source Type: news

By providing more clarity around how these prescription-drug-use-related software products will be regulated, #FDA hopes to promote development of these innovations. We believe these innovative products can help significantly improve patients ’ health
By providing more clarity around how these prescription-drug-use-related software products will be regulated, #FDA hopes to promote development of these innovations. We believe these innovative products can help significantly improve patients’ health (Source: Food and Drug Adminstration (FDA): CDRHNew)
Source: Food and Drug Adminstration (FDA): CDRHNew - November 19, 2018 Category: Medical Devices Authors: ( at SGottliebFDA) Source Type: news

How we regulate this space is important. Consider, for example, a sensor that collects data to track a drug as it moves through the body after being ingested to promote compliance or monitor how a drug is working.
(Source: Food and Drug Adminstration (FDA): CDRHNew)
Source: Food and Drug Adminstration (FDA): CDRHNew - November 19, 2018 Category: Medical Devices Authors: ( at SGottliebFDA) Source Type: news

The #FDA wants to promote the development of #digitaltech that can also help guide the safe and effective use of prescription drugs, to help patients improve their health https://go.usa.gov/xPAak   pic.twitter.com/nRPaMkKini
The #FDA wants to promote the development of #digitaltech that can also help guide the safe and effective use of prescription drugs, to help patients improve their health https://go.usa.gov/xPAak  pic.twitter.com/nRPaMkKini (Source: Food and Drug Adminstration (FDA): CDRHNew)
Source: Food and Drug Adminstration (FDA): CDRHNew - November 19, 2018 Category: Medical Devices Authors: ( at SGottliebFDA) Source Type: news

The @US_FDA issues a safety communication cautioning doctors & patients of the risks associated w/ using medications that are not approved for use w/ implanted pumps that are delivered into the spinal fluid to treat or manage pain: https://go.usa.gov/xPfuw   #FDA #MedicalDevicepic.twitter.com/kgDSx2PQzn
The @US_FDA issues a safety communication cautioning doctors & patients of the risks associated w/ using medications that are not approved for use w/ implanted pumps that are delivered into the spinal fluid to treat or manage pain: https://go.usa.gov/xPfuw  #FDA #MedicalDevice pic.twitter.com/kgDSx2PQzn (Source: Food and Drug Adminstration (FDA): CDRHNew)
Source: Food and Drug Adminstration (FDA): CDRHNew - November 14, 2018 Category: Medical Devices Authors: ( at FDADeviceInfo) Source Type: news

Caring for a loved one? Be prepared for any situation. 4 tips to help you keep you loved one safe: http://www.fda.gov/caregivertips   #NationalFamilyCaregiversMonthpic.twitter.com/DpNpz8NCDe
Caring for a loved one? Be prepared for any situation. 4 tips to help you keep you loved one safe: http://www.fda.gov/caregivertips  #NationalFamilyCaregiversMonth pic.twitter.com/DpNpz8NCDe (Source: Food and Drug Adminstration (FDA): CDRHNew)
Source: Food and Drug Adminstration (FDA): CDRHNew - November 14, 2018 Category: Medical Devices Authors: ( at FDAWomen) Source Type: news

#DYK November is #DiabetesAwarenessMonth. As the number of people diagnosed with diabetes continues to grow, @US_FDA encourages patients and caregivers to beware of illegally markets diabetes treatments. Check out our Consumer Update on this issue https://go.usa.gov/xPfDx   pic.twitter.com/OGwOusdP1w
#DYK November is #DiabetesAwarenessMonth. As the number of people diagnosed with diabetes continues to grow, @US_FDA encourages patients and caregivers to beware of illegally markets diabetes treatments. Check out our Consumer Update on this issue https://go.usa.gov/xPfDx  pic.twitter.com/OGwOusdP1w (Source: Food and Drug Adminstration (FDA): CDRHNew)
Source: Food and Drug Adminstration (FDA): CDRHNew - November 13, 2018 Category: Medical Devices Authors: ( at FDADeviceInfo) Source Type: news

Check out the #PEAC2018 agenda, webcast information, and meeting materials for Thursday ’ s Patient Engagement Advisory Committee meeting on http://FDA.gov   : https://go.usa.gov/xPf9n   #DigitalHealthpic.twitter.com/1DCieYB33v
Check out the #PEAC2018 agenda, webcast information, and meeting materials for Thursday’s Patient Engagement Advisory Committee meeting on http://FDA.gov : https://go.usa.gov/xPf9n  #DigitalHealth pic.twitter.com/1DCieYB33v (Source: Food and Drug Adminstration (FDA): CDRHNew)
Source: Food and Drug Adminstration (FDA): CDRHNew - November 13, 2018 Category: Medical Devices Authors: ( at FDADeviceInfo) Source Type: news

Health information for those affected by #WoolseyFire is available on our website at: http://publichealth.lacounty.gov/media/FireSafety   … - Food safety - Ash clean-up - Smoke and air qualitypic.twitter.com/8HC7NoLaXB
Health information for those affected by #WoolseyFire is available on our website at: http://publichealth.lacounty.gov/media/FireSafety … - Food safety - Ash clean-up - Smoke and air quality pic.twitter.com/8HC7NoLaXB (Source: Food and Drug Adminstration (FDA): CDRHNew)
Source: Food and Drug Adminstration (FDA): CDRHNew - November 13, 2018 Category: Medical Devices Authors: ( at lapublichealth) Source Type: news

#DYK November is #DiabetesAwarenessMonth. As the number of people diagnosed with diabetes continues to grow, @US_FDA encourages patients and caregivers to beware of illegally markets diabetes treatments. Check out our Consumer Update on this issue https://go.usa.gov/xPfDx   pic.twitter.com/RkqeIjaXPk
#DYK November is #DiabetesAwarenessMonth. As the number of people diagnosed with diabetes continues to grow, @US_FDA encourages patients and caregivers to beware of illegally markets diabetes treatments. Check out our Consumer Update on this issue https://go.usa.gov/xPfDx  pic.twitter.com/RkqeIjaXPk (Source: Food and Drug Adminstration (FDA): CDRHNew)
Source: Food and Drug Adminstration (FDA): CDRHNew - November 13, 2018 Category: Medical Devices Authors: ( at FDADeviceInfo) Source Type: news

Recent Ebola outbreaks in remote areas with limited resources can benefit from rapid diagnostic tools, and the issuance of today ’ s EUA is an important step in addressing these outbreaks. http://go.usa.gov/xPvs4   pic.twitter.com/o2I1dYUQCx
Recent Ebola outbreaks in remote areas with limited resources can benefit from rapid diagnostic tools, and the issuance of today’s EUA is an important step in addressing these outbreaks. http://go.usa.gov/xPvs4  pic.twitter.com/o2I1dYUQCx (Source: Food and Drug Adminstration (FDA): CDRHNew)
Source: Food and Drug Adminstration (FDA): CDRHNew - November 9, 2018 Category: Medical Devices Authors: ( at US_FDA) Source Type: news

There's only 1 week until the 2018 Patient Engagement Advisory Committee meeting. Join the @US_FDA on Nov 15 to discuss patient-generated health data from sources like social media, activity trackers, and patient-driven registries.pic.twitter.com/WkDNnXqmbw
There's only 1 week until the 2018 Patient Engagement Advisory Committee meeting. Join the @US_FDA on Nov 15 to discuss patient-generated health data from sources like social media, activity trackers, and patient-driven registries. pic.twitter.com/WkDNnXqmbw (Source: Food and Drug Adminstration (FDA): CDRHNew)
Source: Food and Drug Adminstration (FDA): CDRHNew - November 8, 2018 Category: Medical Devices Authors: ( at FDADeviceInfo) Source Type: news

Learn more about the #PEAC2018 meeting: https://go.usa.gov/xPvTx   #DigitalHealth
Learn more about the #PEAC2018 meeting: https://go.usa.gov/xPvTx  #DigitalHealth (Source: Food and Drug Adminstration (FDA): CDRHNew)
Source: Food and Drug Adminstration (FDA): CDRHNew - November 8, 2018 Category: Medical Devices Authors: ( at FDADeviceInfo) Source Type: news

November is #DiabetesAwarenessMonth #DYK using a glucose meter to check and monitor blood sugar is a daily part of life for millions of Americans with diabetes? Check out the @US_FDA's tips on how to safely use glucose meters and test strips for diabetes: https://go.usa.gov/xPdK4  
November is #DiabetesAwarenessMonth #DYK using a glucose meter to check and monitor blood sugar is a daily part of life for millions of Americans with diabetes? Check out the @US_FDA's tips on how to safely use glucose meters and test strips for diabetes: https://go.usa.gov/xPdK4  (Source: Food and Drug Adminstration (FDA): CDRHNew)
Source: Food and Drug Adminstration (FDA): CDRHNew - November 6, 2018 Category: Medical Devices Authors: ( at FDADeviceInfo) Source Type: news

.@US_FDA issues a class I recall: Roche Diagnostics recalls CoaguChek XS PT Test Strips due to inaccurate INR test results. Find out more: https://go.usa.gov/xPVER   #FDA #MedicalDevicepic.twitter.com/EYmVZHrUZc
. @US_FDA issues a class I recall: Roche Diagnostics recalls CoaguChek XS PT Test Strips due to inaccurate INR test results. Find out more: https://go.usa.gov/xPVER  #FDA #MedicalDevice pic.twitter.com/EYmVZHrUZc (Source: Food and Drug Adminstration (FDA): CDRHNew)
Source: Food and Drug Adminstration (FDA): CDRHNew - November 2, 2018 Category: Medical Devices Authors: ( at FDADeviceInfo) Source Type: news

Check out @US_FDA's information on Direct-to-Consumer Tests: https://go.usa.gov/xPVPu   #MedicalDevice #FDA
Check out @US_FDA's information on Direct-to-Consumer Tests: https://go.usa.gov/xPVPu  #MedicalDevice #FDA (Source: Food and Drug Adminstration (FDA): CDRHNew)
Source: Food and Drug Adminstration (FDA): CDRHNew - November 2, 2018 Category: Medical Devices Authors: ( at FDADeviceInfo) Source Type: news

Use the clock change this Sunday as a reminder to check your emergency supplies! http://goo.gl/aasVQ   #clocksstocks @GetReadypic.twitter.com/sHD5vhCeEu
Use the clock change this Sunday as a reminder to check your emergency supplies! http://goo.gl/aasVQ  #clocksstocks @GetReady pic.twitter.com/sHD5vhCeEu (Source: Food and Drug Adminstration (FDA): CDRHNew)
Source: Food and Drug Adminstration (FDA): CDRHNew - November 2, 2018 Category: Medical Devices Authors: ( at PublicHealth) Source Type: news

#DYK the @US_FDA recently authorized the first direct-to-consumer test for detecting genetic variants that may be associated with medication metabolism? Learn more about the authorization: https://go.usa.gov/xPVUt   #MedicalDevice #FDA
#DYK the @US_FDA recently authorized the first direct-to-consumer test for detecting genetic variants that may be associated with medication metabolism? Learn more about the authorization: https://go.usa.gov/xPVUt  #MedicalDevice #FDA (Source: Food and Drug Adminstration (FDA): CDRHNew)
Source: Food and Drug Adminstration (FDA): CDRHNew - November 2, 2018 Category: Medical Devices Authors: ( at FDADeviceInfo) Source Type: news