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

An #FDA-sponsored study found that women were underrepresented in trials for medicines to treat heart failure, coronary artery disease and acute coronary syndrome. Drs were less likely to refer women for studies, due in part to their more advanced age and other medical conditionspic.twitter.com/eayH2Wgsml
An #FDA-sponsored study found that women were underrepresented in trials for medicines to treat heart failure, coronary artery disease and acute coronary syndrome. Drs were less likely to refer women for studies, due in part to their more advanced age and other medical conditions pic.twitter.com/eayH2Wgsml (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 inclusion of women in clinical trials is much better today but challenges remain. Women now make up a large portion of the clinical trial population but are less commonly included in trials for certain kinds of conditions, including certain kinds of heart disease.pic.twitter.com/k4lb4VHdSL
The inclusion of women in clinical trials is much better today but challenges remain. Women now make up a large portion of the clinical trial population but are less commonly included in trials for certain kinds of conditions, including certain kinds of heart disease. pic.twitter.com/k4lb4VHdSL (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

In the 1960s, babies were born overseas with birth defects because their mothers took the sedative thalidomide during pregnancy. #FDA did not approve that drug for sale but in its aftermath, women of child-bearing age generally were excluded from clinical trials from 1977-1993.
(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

FDA can make better product safety decisions if women are included in clinical trials. OWH works withe #FDA's medical product centers to advocate for such inclusion but ensuring a sufficient number of women in trials is an ongoing effort https://go.usa.gov/xPnvK   .
FDA can make better product safety decisions if women are included in clinical trials. OWH works withe #FDA's medical product centers to advocate for such inclusion but ensuring a sufficient number of women in trials is an ongoing effort https://go.usa.gov/xPnvK . (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

Another OWH project: encouraging women to enroll in pregnancy exposure registries if they must take a medicine while pregnant. This information is compared w/ women who don ’ t take medicine during pregnancy. It can help improve safety information and be used to update labeling.pic.twitter.com/Dq2YiuBTVH
Another OWH project: encouraging women to enroll in pregnancy exposure registries if they must take a medicine while pregnant. This information is compared w/ women who don’t take medicine during pregnancy. It can help improve safety information and be used to update labeling. pic.twitter.com/Dq2YiuBTVH (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

In addition to its scientific efforts, OWH also conducts public health campaigns. Its Heart Health For Women, is to dispel the myth that heart disease primarily affects men. In fact, heart disease is the leading cause of death in BOTH men and women https://go.usa.gov/xPnph   .pic.twitter.com/Pa6S6s1Ayq
In addition to its scientific efforts, OWH also conducts public health campaigns. Its Heart Health For Women, is to dispel the myth that heart disease primarily affects men. In fact, heart disease is the leading cause of death in BOTH men and women https://go.usa.gov/xPnph . pic.twitter.com/Pa6S6s1Ayq (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

Our Office of Women ’ s Health (OWH), established in 1994 to promote and advance the health of women, has awarded over $40 million in research funding for over 371 projects, including pioneering work on drug-induced heart rhythm irregularities. https://go.usa.gov/xPnvT  
Our Office of Women’s Health (OWH), established in 1994 to promote and advance the health of women, has awarded over $40 million in research funding for over 371 projects, including pioneering work on drug-induced heart rhythm irregularities. https://go.usa.gov/xPnvT  (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

FDA is helping to develop new and better data sources to identify sex-specific differences and to better evaluate medical products developed for women ’ s health. One example: the women ’ s health technology Coordinated Registry Network https://bit.ly/2L4Tqsx   .
FDA is helping to develop new and better data sources to identify sex-specific differences and to better evaluate medical products developed for women’s health. One example: the women’s health technology Coordinated Registry Network https://bit.ly/2L4Tqsx . (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 #FDA recently hosted a conference on the influence of sex and gender in opioid and nicotine use to increase awareness of the differences in response, discuss the needs of women battling addiction to better inform policy, and consider treatment options https://go.usa.gov/xPnpA   .pic.twitter.com/kqY9dabVOP
The #FDA recently hosted a conference on the influence of sex and gender in opioid and nicotine use to increase awareness of the differences in response, discuss the needs of women battling addiction to better inform policy, and consider treatment options https://go.usa.gov/xPnpA . pic.twitter.com/kqY9dabVOP (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

Confronting Addiction: Differences in metabolism and brain circuitry mean that women also differ from men in their response to opioid and nicotine use. For example, women become dependent on certain addictive substances more quickly and may experience withdrawal more intensely.pic.twitter.com/RvSurrEdpN
Confronting Addiction: Differences in metabolism and brain circuitry mean that women also differ from men in their response to opioid and nicotine use. For example, women become dependent on certain addictive substances more quickly and may experience withdrawal more intensely. pic.twitter.com/RvSurrEdpN (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

Save the date & Join the @US_FDA ’ s Patient Engagement Advisory Committee on Nov 15th to discuss patient-generated health data from sources like social media, activity trackers, and patient-driven registries. Learn more: https://go.usa.gov/xPRau   #DigitalHealth #PEAC2018pic.twitter.com/NU61Snpxxw
Save the date & Join the @US_FDA’s Patient Engagement Advisory Committee on Nov 15th to discuss patient-generated health data from sources like social media, activity trackers, and patient-driven registries. Learn more: https://go.usa.gov/xPRau  #DigitalHealth #PEAC2018 pic.twitter.com/NU61Snpxxw (Source: Food and Drug Adminstration (FDA): CDRHNew)
Source: Food and Drug Adminstration (FDA): CDRHNew - October 17, 2018 Category: Medical Devices Authors: ( at FDADeviceInfo) Source Type: news

National Cybersecurity Awareness Month is in its 3rd week. This week's theme: “ Strengthening the Cybersecurity Workforce Across All Sectors ” . Go to https://www.dhs.gov/stopthinkconnect   … to see what #NCSAM is all about. #FDA #MedicalDevicespic.twitter.com/KBLIxo9CiV
National Cybersecurity Awareness Month is in its 3rd week. This week's theme: “Strengthening the Cybersecurity Workforce Across All Sectors”. Go to https://www.dhs.gov/stopthinkconnect … to see what #NCSAM is all about. #FDA #MedicalDevices pic.twitter.com/KBLIxo9CiV (Source: Food and Drug Adminstration (FDA): CDRHNew)
Source: Food and Drug Adminstration (FDA): CDRHNew - October 15, 2018 Category: Medical Devices Authors: ( at FDADeviceInfo) Source Type: news

The 2nd week of National Cybersecurity Awareness Month is here! This week ’ s theme: “ Cybersecurity = A Cross-Cutting Challenge to Tackle Together ” . Learn more about #NCSAM at https://www.dhs.gov/stopthinkconnect   … . #FDA #MedicalDevicespic.twitter.com/H3rUbSyLPq
The 2nd week of National Cybersecurity Awareness Month is here! This week’s theme: “Cybersecurity = A Cross-Cutting Challenge to Tackle Together”. Learn more about #NCSAM at https://www.dhs.gov/stopthinkconnect …. #FDA #MedicalDevices pic.twitter.com/H3rUbSyLPq (Source: Food and Drug Adminstration (FDA): CDRHNew)
Source: Food and Drug Adminstration (FDA): CDRHNew - October 12, 2018 Category: Medical Devices Authors: ( at FDADeviceInfo) Source Type: news

Cybersecurity Updates Affecting Medtronic Implantable Cardiac Device Programmers: FDA Safety Communication https://go.usa.gov/xPXRN   #fda #medicaldevice
Cybersecurity Updates Affecting Medtronic Implantable Cardiac Device Programmers: FDA Safety Communication https://go.usa.gov/xPXRN  #fda #medicaldevice (Source: Food and Drug Adminstration (FDA): CDRHNew)
Source: Food and Drug Adminstration (FDA): CDRHNew - October 11, 2018 Category: Medical Devices Authors: ( at FDADeviceInfo) Source Type: news

If you use a #MedicalDevice affected by a power outage caused by #HurricaneMichael, check out the #FDA ’ s tips for using a generator to restore power to your device: https://go.usa.gov/xPjau   pic.twitter.com/SLxGKzIIgc
If you use a #MedicalDevice affected by a power outage caused by #HurricaneMichael, check out the #FDA’s tips for using a generator to restore power to your device: https://go.usa.gov/xPjau  pic.twitter.com/SLxGKzIIgc (Source: Food and Drug Adminstration (FDA): CDRHNew)
Source: Food and Drug Adminstration (FDA): CDRHNew - October 10, 2018 Category: Medical Devices Authors: ( at FDADeviceInfo) Source Type: news

#HurricaneMichael continues to move inland and remains a major hurricane. An extreme wind warning is in effect for portions of the Ern FL Panhandle & extreme SW GA for winds > 115 MPH valid until 345 PM CT. If you are in the EWW, TAKE SHELTER NOW!!!pic.twitter.com/Mhx4LNoJCr
#HurricaneMichael continues to move inland and remains a major hurricane. An extreme wind warning is in effect for portions of the Ern FL Panhandle & extreme SW GA for winds>115 MPH valid until 345 PM CT. If you are in the EWW, TAKE SHELTER NOW!!! pic.twitter.com/Mhx4LNoJCr (Source: Food and Drug Adminstration (FDA): CDRHNew)
Source: Food and Drug Adminstration (FDA): CDRHNew - October 10, 2018 Category: Medical Devices Authors: ( at NWSTallahassee) Source Type: news

As Hurricane #Michael nears land, take shelter & stay safe. Follow weather updates on your phone or radio. In a tornado WARNING, go to an interior, windowless room. If water comes in, go to the highest floor that ’ s not flooded but do NOT enter a closed attic.pic.twitter.com/KD5WZ7gamP
As Hurricane #Michael nears land, take shelter & stay safe. Follow weather updates on your phone or radio. In a tornado WARNING, go to an interior, windowless room. If water comes in, go to the highest floor that’s not flooded but do NOT enter a closed attic. pic.twitter.com/KD5WZ7gamP (Source: Food and Drug Adminstration (FDA): CDRHNew)
Source: Food and Drug Adminstration (FDA): CDRHNew - October 10, 2018 Category: Medical Devices Authors: ( at fema) Source Type: news

#FDA is closely tracking #Michael and has activated its Emergency Operations Center to support federal and state efforts in GA, FL, and AL. Additionally, we are taking steps to prevent any potential drug shortages and will share more over the coming days #HurricaneMichael
(Source: Food and Drug Adminstration (FDA): CDRHNew)
Source: Food and Drug Adminstration (FDA): CDRHNew - October 9, 2018 Category: Medical Devices Authors: ( at FDASpox) Source Type: news

#ICYMI - FDA issues recommendations to help prevent surgical fires and related patient injury. Click the link to read the recommendations: https://go.usa.gov/xQdwG   #FirePreventionWeek #MedicalDevice
#ICYMI - FDA issues recommendations to help prevent surgical fires and related patient injury. Click the link to read the recommendations: https://go.usa.gov/xQdwG  #FirePreventionWeek #MedicalDevice (Source: Food and Drug Adminstration (FDA): CDRHNew)
Source: Food and Drug Adminstration (FDA): CDRHNew - October 9, 2018 Category: Medical Devices Authors: ( at FDADeviceInfo) Source Type: news

September 2018 PMA Approval List https://go.usa.gov/xPkSh   #fda #medicaldevice
September 2018 PMA Approval List https://go.usa.gov/xPkSh  #fda #medicaldevice (Source: Food and Drug Adminstration (FDA): CDRHNew)
Source: Food and Drug Adminstration (FDA): CDRHNew - October 5, 2018 Category: Medical Devices Authors: ( at FDADeviceInfo) Source Type: news

Devices flag! The FDA has allowed the marketing a new type of hearing aid, a self-fitted hearing aid controlled by the user. Interested reporters should check out our press release: https://go.usa.gov/xPkuB  
Devices flag! The FDA has allowed the marketing a new type of hearing aid, a self-fitted hearing aid controlled by the user. Interested reporters should check out our press release: https://go.usa.gov/xPkuB  (Source: Food and Drug Adminstration (FDA): CDRHNew)
Source: Food and Drug Adminstration (FDA): CDRHNew - October 5, 2018 Category: Medical Devices Authors: ( at FDASpox) Source Type: news

My statement on the #FDA ’ s new efforts to strengthen the agency ’ s medical device cybersecurity program as part of our mission to protect patients http://go.usa.gov/xPBK2   pic.twitter.com/8w5m5itceW
My statement on the #FDA’s new efforts to strengthen the agency’s medical device cybersecurity program as part of our mission to protect patients http://go.usa.gov/xPBK2  pic.twitter.com/8w5m5itceW (Source: Food and Drug Adminstration (FDA): CDRHNew)
Source: Food and Drug Adminstration (FDA): CDRHNew - October 1, 2018 Category: Medical Devices Authors: ( at SGottliebFDA) Source Type: news

National Cybersecurity Awareness Month has begun. This week ’ s theme is “ Strengthening the Cybersecurity Ecosystem. ” Click the link to learn more about #NCSAM: https://go.usa.gov/xPZqb   #FDA #MedicalDevicespic.twitter.com/qOMDykqcxP
National Cybersecurity Awareness Month has begun. This week’s theme is “Strengthening the Cybersecurity Ecosystem.” Click the link to learn more about #NCSAM: https://go.usa.gov/xPZqb  #FDA #MedicalDevices pic.twitter.com/qOMDykqcxP (Source: Food and Drug Adminstration (FDA): CDRHNew)
Source: Food and Drug Adminstration (FDA): CDRHNew - October 1, 2018 Category: Medical Devices Authors: ( at FDADeviceInfo) Source Type: news

Today is the last day to submit applications to the #FDAInnovationChallenge. Thanks to all who have applied. Selected applications will be announced in November. For more information about the challenge, click the link: https://go.usa.gov/xP4Nk   pic.twitter.com/pFJZ39oGJC
Today is the last day to submit applications to the #FDAInnovationChallenge. Thanks to all who have applied. Selected applications will be announced in November. For more information about the challenge, click the link: https://go.usa.gov/xP4Nk  pic.twitter.com/pFJZ39oGJC (Source: Food and Drug Adminstration (FDA): CDRHNew)
Source: Food and Drug Adminstration (FDA): CDRHNew - September 30, 2018 Category: Medical Devices Authors: ( at FDADeviceInfo) Source Type: news

Reminder: the last day to submit applications to the #FDAInnovationChallenge is tomorrow, September 30th. Click the link to find out more about the challenge and how to submit your application: https://go.usa.gov/xP4Nk   pic.twitter.com/lLYiMa0cLe
Reminder: the last day to submit applications to the #FDAInnovationChallenge is tomorrow, September 30th. Click the link to find out more about the challenge and how to submit your application: https://go.usa.gov/xP4Nk  pic.twitter.com/lLYiMa0cLe (Source: Food and Drug Adminstration (FDA): CDRHNew)
Source: Food and Drug Adminstration (FDA): CDRHNew - September 29, 2018 Category: Medical Devices Authors: ( at FDADeviceInfo) Source Type: news

We want to help patients/caregivers know how to use pen needles correctly. FDA received reports of patients using standard pen needles to inject insulin w/o removing the inner needle cover. The cover stopped patients from getting the right amnt of insulin https://go.usa.gov/xPWZq   pic.twitter.com/LT9SptJge1
We want to help patients/caregivers know how to use pen needles correctly. FDA received reports of patients using standard pen needles to inject insulin w/o removing the inner needle cover. The cover stopped patients from getting the right amnt of insulin https://go.usa.gov/xPWZq  pic.twitter.com/LT9SptJge1 (Source: Food and Drug Adminstration (FDA): CDRHNew)
Source: Food and Drug Adminstration (FDA): CDRHNew - September 27, 2018 Category: Medical Devices Authors: ( at FDASpox) Source Type: news

Read about how the FDA is seeking more resources in FY2019 to help advance our #FDAPrecert model for #DigitalHealth-modernizing our regulatory approach to help innovate digital health technologies, while protecting patients. Click here: https://go.usa.gov/xPWZ3   #mobilehealth
Read about how the FDA is seeking more resources in FY2019 to help advance our #FDAPrecert model for #DigitalHealth-modernizing our regulatory approach to help innovate digital health technologies, while protecting patients. Click here: https://go.usa.gov/xPWZ3  #mobilehealth (Source: Food and Drug Adminstration (FDA): CDRHNew)
Source: Food and Drug Adminstration (FDA): CDRHNew - September 27, 2018 Category: Medical Devices Authors: ( at FDADeviceInfo) Source Type: news

Today, the National Breast Implant Registry opened. This new registry, a collaboration between @ASPSMembers, implant manufacturers and #FDA, provides an important new platform for evaluating real world data on the safety and performance of breast implants https://bit.ly/2OU7wKX  
Today, the National Breast Implant Registry opened. This new registry, a collaboration between @ASPSMembers, implant manufacturers and #FDA, provides an important new platform for evaluating real world data on the safety and performance of breast implants https://bit.ly/2OU7wKX  (Source: Food and Drug Adminstration (FDA): CDRHNew)
Source: Food and Drug Adminstration (FDA): CDRHNew - September 26, 2018 Category: Medical Devices Authors: ( at SGottliebFDA) Source Type: news

#DYK that condoms are considered #MedicalDevices? Click the link to learn more about the #FDA ’ s role in regulating contraceptive devices to protect your sexual health: https://go.usa.gov/xPDQw  
#DYK that condoms are considered #MedicalDevices? Click the link to learn more about the #FDA’s role in regulating contraceptive devices to protect your sexual health: https://go.usa.gov/xPDQw  (Source: Food and Drug Adminstration (FDA): CDRHNew)
Source: Food and Drug Adminstration (FDA): CDRHNew - September 26, 2018 Category: Medical Devices Authors: ( at FDADeviceInfo) Source Type: news

The single-use internal condom (formerly the single-use female condom) is the only female-controlled barrier method intended to provide protection against pregnancy & STI transmission. Check out the FDA's birth control guide: https://go.usa.gov/xPDQw   #MedicalDevices
The single-use internal condom (formerly the single-use female condom) is the only female-controlled barrier method intended to provide protection against pregnancy & STI transmission. Check out the FDA's birth control guide: https://go.usa.gov/xPDQw  #MedicalDevices (Source: Food and Drug Adminstration (FDA): CDRHNew)
Source: Food and Drug Adminstration (FDA): CDRHNew - September 26, 2018 Category: Medical Devices Authors: ( at FDADeviceInfo) Source Type: news

Today, Wednesday, September 26th 2018 at 12 pm EST is the last day that the #FDA will be soliciting site visit proposals for the 2018 Experiential Learning Program. Click the link to find more about the program & submit your application: http://go.usa.gov/xPrum   #MedicalDevicepic.twitter.com/Zsmq00NCdd
Today, Wednesday, September 26th 2018 at 12 pm EST is the last day that the #FDA will be soliciting site visit proposals for the 2018 Experiential Learning Program. Click the link to find more about the program & submit your application: http://go.usa.gov/xPrum  #MedicalDevice pic.twitter.com/Zsmq00NCdd (Source: Food and Drug Adminstration (FDA): CDRHNew)
Source: Food and Drug Adminstration (FDA): CDRHNew - September 26, 2018 Category: Medical Devices Authors: ( at FDADeviceInfo) Source Type: news

Conducting clinical trials & preparing a submission for #FDA review? Register for #CDERSBIA ’ s Clinical Investigator Training Course: November 13-15 to learn about FDA regulations, scientific principles for conducting clinical trials, & more! https://go.usa.gov/xPqku   .pic.twitter.com/Ktqq9Slx0y
Conducting clinical trials & preparing a submission for #FDA review? Register for #CDERSBIA’s Clinical Investigator Training Course: November 13-15 to learn about FDA regulations, scientific principles for conducting clinical trials, & more! https://go.usa.gov/xPqku . pic.twitter.com/Ktqq9Slx0y (Source: Food and Drug Adminstration (FDA): CDRHNew)
Source: Food and Drug Adminstration (FDA): CDRHNew - September 25, 2018 Category: Medical Devices Authors: ( at FDA_Drug_Info) Source Type: news