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

The @US_FDA issues a letter to health care providers regarding possible battery failure in Getinge's Maquet/Datascope intra-aortic balloon pumps. Read the letter here: https://go.usa.gov/xPyHT   #MedicalDevice
The @US_FDA issues a letter to health care providers regarding possible battery failure in Getinge's Maquet/Datascope intra-aortic balloon pumps. Read the letter here: https://go.usa.gov/xPyHT  #MedicalDevice (Source: Food and Drug Adminstration (FDA): CDRHNew)
Source: Food and Drug Adminstration (FDA): CDRHNew - November 1, 2018 Category: Medical Devices Authors: ( at FDADeviceInfo) Source Type: news

The @US_FDA warns patients & health care providers should not change drug treatment based on results from certain genetic tests w/ unapproved claims to predict a patient ’ s response to specific medications. Read the Safety Communication here: https://go.usa.gov/xPysF   #MedicalDevice
The @US_FDA warns patients & health care providers should not change drug treatment based on results from certain genetic tests w/ unapproved claims to predict a patient’s response to specific medications. Read the Safety Communication here: https://go.usa.gov/xPysF  #MedicalDevice (Source: Food and Drug Adminstration (FDA): CDRHNew)
Source: Food and Drug Adminstration (FDA): CDRHNew - November 1, 2018 Category: Medical Devices Authors: ( at FDADeviceInfo) Source Type: news

#DYK: Mammograms are still the best tool for breast cancer screening. Check out @US_FDA ’ s information on the importance of choosing a certified mammography facility: https://go.usa.gov/xPPpT   #MedicalDevice #BreastCancerAwarenessMonthpic.twitter.com/YaGqeGgrTH
#DYK: Mammograms are still the best tool for breast cancer screening. Check out @US_FDA’s information on the importance of choosing a certified mammography facility: https://go.usa.gov/xPPpT  #MedicalDevice #BreastCancerAwarenessMonth pic.twitter.com/YaGqeGgrTH (Source: Food and Drug Adminstration (FDA): CDRHNew)
Source: Food and Drug Adminstration (FDA): CDRHNew - October 30, 2018 Category: Medical Devices Authors: ( at FDADeviceInfo) Source Type: news

Men can also be diagnosed with breast cancer. Check out the @US_FDA ’ s information regarding breast cancer in men, available treatments and counseling options: https://go.usa.gov/xPPpx   ) #MedicalDevice #BreastCancerAwarenessMonthpic.twitter.com/aZBjgCGsB1
Men can also be diagnosed with breast cancer. Check out the @US_FDA’s information regarding breast cancer in men, available treatments and counseling options: https://go.usa.gov/xPPpx  ) #MedicalDevice #BreastCancerAwarenessMonth pic.twitter.com/aZBjgCGsB1 (Source: Food and Drug Adminstration (FDA): CDRHNew)
Source: Food and Drug Adminstration (FDA): CDRHNew - October 26, 2018 Category: Medical Devices Authors: ( at FDADeviceInfo) Source Type: news

Stay informed of the most effective breast cancer screening options by checking out our consumer update warning against the use of thermography as mammogram substitute: https://go.usa.gov/xPUA7   #FDA #MedicalDevice #BreastCancerAwarenessMonth
Stay informed of the most effective breast cancer screening options by checking out our consumer update warning against the use of thermography as mammogram substitute: https://go.usa.gov/xPUA7  #FDA #MedicalDevice #BreastCancerAwarenessMonth (Source: Food and Drug Adminstration (FDA): CDRHNew)
Source: Food and Drug Adminstration (FDA): CDRHNew - October 24, 2018 Category: Medical Devices Authors: ( at FDADeviceInfo) Source Type: news

It ’ s #BreastCancerAwarenessMonth and the @US_FDA is reminding patients and caregivers that thermography is not a substitute for mammograms.pic.twitter.com/XGJFHvut4x
It’s #BreastCancerAwarenessMonth and the @US_FDA is reminding patients and caregivers that thermography is not a substitute for mammograms. pic.twitter.com/XGJFHvut4x (Source: Food and Drug Adminstration (FDA): CDRHNew)
Source: Food and Drug Adminstration (FDA): CDRHNew - October 24, 2018 Category: Medical Devices Authors: ( at FDADeviceInfo) Source Type: news

Whether it ’ s funding scientific research, examining policy approaches to vexing safety issues, or launching public education campaigns, you can be assured that this is a top commitment for us, and #FDA is fully engaged in promoting and protecting the health of the nation ’ s womenpic.twitter.com/euQki9iqsL
Whether it’s funding scientific research, examining policy approaches to vexing safety issues, or launching public education campaigns, you can be assured that this is a top commitment for us, and #FDA is fully engaged in promoting and protecting the health of the nation’s women pic.twitter.com/euQki9iqsL (Source: Food and Drug Adminstration (FDA): CDRHNew)
Source: Food and Drug Adminstration (FDA): CDRHNew - October 21, 2018 Category: Medical Devices Authors: ( at SGottliebFDA) Source Type: news

It ’ s concerning that many women who qualify for a mammogram don ’ t go for regular screening, in part due to common myths like mammograms “ are painful ” or “ cause cancer. ” During this Breast Cancer Awareness month, I urge women to check the facts https://go.usa.gov/xPnyD   .pic.twitter.com/DGz5Xvquky
It’s concerning that many women who qualify for a mammogram don’t go for regular screening, in part due to common myths like mammograms “are painful” or “cause cancer.” During this Breast Cancer Awareness month, I urge women to check the facts https://go.usa.gov/xPnyD . pic.twitter.com/DGz5Xvquky (Source: Food and Drug Adminstration (FDA): CDRHNew)
Source: Food and Drug Adminstration (FDA): CDRHNew - October 21, 2018 Category: Medical Devices Authors: ( at SGottliebFDA) Source Type: news

We know that cancer is harder to find in women with dense breasts – some women may need other imaging tests. Breast density reporting is already required in some states. Expanding this nationwide will empower patients and providers to make more informed health decisions.
We know that cancer is harder to find in women with dense breasts – some women may need other imaging tests. Breast density reporting is already required in some states. Expanding this nationwide will empower patients and providers to make more informed health decisions. (Source: Food and Drug Adminstration (FDA): CDRHNew)
Source: Food and Drug Adminstration (FDA): CDRHNew - October 21, 2018 Category: Medical Devices Authors: ( at SGottliebFDA) Source Type: news

We ’ re now moving to update/modernize our oversight to capitalize on a # of important advances, including the increased use of digital imaging, revised screening recommendations from the @CDCgov and need for uniform nation-wide breast density reporting https://go.usa.gov/xPnyd   .
We’re now moving to update/modernize our oversight to capitalize on a # of important advances, including the increased use of digital imaging, revised screening recommendations from the @CDCgov and need for uniform nation-wide breast density reporting https://go.usa.gov/xPnyd . (Source: Food and Drug Adminstration (FDA): CDRHNew)
Source: Food and Drug Adminstration (FDA): CDRHNew - October 21, 2018 Category: Medical Devices Authors: ( at SGottliebFDA) Source Type: news

The MQSA was intended to address mammography quality concerns and it ’ s been a huge success. Image quality has improved, radiation dose has declined and equipment violations have all but disappeared. Today the 5-year breast cancer survival rate is 95%-99%, up from 84% in 1995.
The MQSA was intended to address mammography quality concerns and it’s been a huge success. Image quality has improved, radiation dose has declined and equipment violations have all but disappeared. Today the 5-year breast cancer survival rate is 95%-99%, up from 84% in 1995. (Source: Food and Drug Adminstration (FDA): CDRHNew)
Source: Food and Drug Adminstration (FDA): CDRHNew - October 21, 2018 Category: Medical Devices Authors: ( at SGottliebFDA) Source Type: news

Under the 1992 Mammography Quality Standards Act (MQSA), #FDA oversees mammography machines and regulates training for people who provide the scans. All mammography facilities must be accredited, certified by FDA or a state certifier and inspected annually https://go.usa.gov/xPnyE   pic.twitter.com/dZzQuYXsJ9
Under the 1992 Mammography Quality Standards Act (MQSA), #FDA oversees mammography machines and regulates training for people who provide the scans. All mammography facilities must be accredited, certified by FDA or a state certifier and inspected annually https://go.usa.gov/xPnyE  pic.twitter.com/dZzQuYXsJ9 (Source: Food and Drug Adminstration (FDA): CDRHNew)
Source: Food and Drug Adminstration (FDA): CDRHNew - October 21, 2018 Category: Medical Devices Authors: ( at SGottliebFDA) Source Type: news

Also, while most of FDA ’ s women ’ s health initiatives are product specific, the #FDA plays an outsize role when it comes to mammography, which produces low-dose x-ray picture of the breast – an important tool to detect breast cancer in its early, most treatable stages.pic.twitter.com/aoYjsSEPrC
Also, while most of FDA’s women’s health initiatives are product specific, the #FDA plays an outsize role when it comes to mammography, which produces low-dose x-ray picture of the breast – an important tool to detect breast cancer in its early, most treatable stages. pic.twitter.com/aoYjsSEPrC (Source: Food and Drug Adminstration (FDA): CDRHNew)
Source: Food and Drug Adminstration (FDA): CDRHNew - October 21, 2018 Category: Medical Devices Authors: ( at SGottliebFDA) Source Type: news

Although I ’ ve been focusing on medical products, we're also advancing our food safety and nutrition work, such as our joint advice w/ EPA on making informed choices about eating fish for women who are pregnant, may become pregnant or are breastfeeding https://go.usa.gov/xPnda   .pic.twitter.com/nktV9BDAC3
Although I’ve been focusing on medical products, we're also advancing our food safety and nutrition work, such as our joint advice w/ EPA on making informed choices about eating fish for women who are pregnant, may become pregnant or are breastfeeding https://go.usa.gov/xPnda . pic.twitter.com/nktV9BDAC3 (Source: Food and Drug Adminstration (FDA): CDRHNew)
Source: Food and Drug Adminstration (FDA): CDRHNew - October 21, 2018 Category: Medical Devices Authors: ( at SGottliebFDA) Source Type: news

Transparency is one way to encourage greater inclusion. Check out our Drug Trials Snapshots - information about who participated in clinical trials supporting a drug ’ s approval and whether there are any demographic differences in benefits or side effects https://go.usa.gov/xPnVQ   .pic.twitter.com/MyoBPe0IGg
Transparency is one way to encourage greater inclusion. Check out our Drug Trials Snapshots - information about who participated in clinical trials supporting a drug’s approval and whether there are any demographic differences in benefits or side effects https://go.usa.gov/xPnVQ . pic.twitter.com/MyoBPe0IGg (Source: Food and Drug Adminstration (FDA): CDRHNew)
Source: Food and Drug Adminstration (FDA): CDRHNew - October 21, 2018 Category: Medical Devices Authors: ( at SGottliebFDA) Source Type: news

Fortunately, while women were underrepresented, the trials were large enough w/adequate # ’ s of women to determine safety and effectiveness. #FDA continues taking steps to encourage greater inclusion of women in trials, including OWH ’ s Diverse Women in Clinical Trials Initiative.pic.twitter.com/20d9Sg2vqn
Fortunately, while women were underrepresented, the trials were large enough w/adequate #’s of women to determine safety and effectiveness. #FDA continues taking steps to encourage greater inclusion of women in trials, including OWH’s Diverse Women in Clinical Trials Initiative. pic.twitter.com/20d9Sg2vqn (Source: Food and Drug Adminstration (FDA): CDRHNew)
Source: Food and Drug Adminstration (FDA): CDRHNew - October 21, 2018 Category: Medical Devices Authors: ( at SGottliebFDA) Source Type: news