The FDA Office of Women ’ s Health was established by Congressional mandate in 1994 to protect and advance the health of women, and to advocate for the participation of women in clinical trials. Learn about how we achieve our mission. http://go.usa.gov/x9J7T   #WomensHistoryMonth
The FDA Office of Women’s Health was established by Congressional mandate in 1994 to protect and advance the health of women, and to advocate for the participation of women in clinical trials. Learn about how we achieve our mission. http://go.usa.gov/x9J7T  #WomensHistoryMonth (Source: Food and Drug Adminstration (FDA): CDRHNew)
Source: Food and Drug Adminstration (FDA): CDRHNew - March 29, 2018 Category: Medical Devices Authors: ( at FDAWomen) Source Type: news

Michelle Tarver, MD, PhD. - Ophthalmologist and Epidemiologist here at the FDA ’ s Center for Devices and Radiological Health, organized the first Patient Engagement Advisory Committee (PEAC) Meeting as Acting Assistant Director of Strategic Programs, CDRH #WomensHistoryMonthpic.twitter.com/ZlMfKbdayV
Michelle Tarver, MD, PhD. - Ophthalmologist and Epidemiologist here at the FDA’s Center for Devices and Radiological Health, organized the first Patient Engagement Advisory Committee (PEAC) Meeting as Acting Assistant Director of Strategic Programs, CDRH #WomensHistoryMonth pic.twitter.com/ZlMfKbdayV (Source: Food and Drug Adminstration (FDA): CDRHNew)
Source: Food and Drug Adminstration (FDA): CDRHNew - March 29, 2018 Category: Medical Devices Authors: ( at FDADeviceInfo) Source Type: news

Courtney Lias and Stayce Beck paved the way for an automated insulin dosing system to receive FDA approval years earlier than expected, helping to make a groundbreaking new device for diabetes management available for Americans with Type 1 diabetes #WomensHistoryMonthpic.twitter.com/t1EyVQAh8t
Courtney Lias and Stayce Beck paved the way for an automated insulin dosing system to receive FDA approval years earlier than expected, helping to make a groundbreaking new device for diabetes management available for Americans with Type 1 diabetes #WomensHistoryMonth pic.twitter.com/t1EyVQAh8t (Source: Food and Drug Adminstration (FDA): CDRHNew)
Source: Food and Drug Adminstration (FDA): CDRHNew - March 28, 2018 Category: Medical Devices Authors: ( at FDADeviceInfo) Source Type: news

The late Lireka P. Joseph served as Chief professional officer for scientists in the Public Health Service Commissioned Corps. #WomensHistoryMonth
(Source: Food and Drug Adminstration (FDA): CDRHNew)
Source: Food and Drug Adminstration (FDA): CDRHNew - March 28, 2018 Category: Medical Devices Authors: ( at FDADeviceInfo) Source Type: news

The “ Lireka P. Joseph Award ” is presented annually to a Center employee or group who exemplifies the professional standards modeled by Rear Admiral Joseph #WomensHistoryMonthpic.twitter.com/L6QZtkjTKl
The “Lireka P. Joseph Award” is presented annually to a Center employee or group who exemplifies the professional standards modeled by Rear Admiral Joseph #WomensHistoryMonth pic.twitter.com/L6QZtkjTKl (Source: Food and Drug Adminstration (FDA): CDRHNew)
Source: Food and Drug Adminstration (FDA): CDRHNew - March 28, 2018 Category: Medical Devices Authors: ( at FDADeviceInfo) Source Type: news

Elizabeth Jacobson. As Acting Director of the Center for Devices and Radiological Health, Elizabeth Jacobson encouraged international harmonization related to the safety, performance and quality of medical devices. #WomensHistoryMonth
Elizabeth Jacobson. As Acting Director of the Center for Devices and Radiological Health, Elizabeth Jacobson encouraged international harmonization related to the safety, performance and quality of medical devices. #WomensHistoryMonth (Source: Food and Drug Adminstration (FDA): CDRHNew)
Source: Food and Drug Adminstration (FDA): CDRHNew - March 27, 2018 Category: Medical Devices Authors: ( at FDADeviceInfo) Source Type: news

In recognition of #WomensHistoryMonth, we are highlighting a few of the many accomplished women who have worked at the FDA ’ s Center for Devices and Radiological Health.pic.twitter.com/GfiXwI1hQt
In recognition of #WomensHistoryMonth , we are highlighting a few of the many accomplished women who have worked at the FDA’s Center for Devices and Radiological Health. pic.twitter.com/GfiXwI1hQt (Source: Food and Drug Adminstration (FDA): CDRHNew)
Source: Food and Drug Adminstration (FDA): CDRHNew - March 27, 2018 Category: Medical Devices Authors: ( at FDADeviceInfo) Source Type: news

FDA has a new update to the ongoing lead test investigation. A chemical interference from tube stoppers is a contributing factor https://go.usa.gov/xQx6e  
FDA has a new update to the ongoing lead test investigation. A chemical interference from tube stoppers is a contributing factor https://go.usa.gov/xQx6e  (Source: Food and Drug Adminstration (FDA): CDRHNew)
Source: Food and Drug Adminstration (FDA): CDRHNew - March 22, 2018 Category: Medical Devices Authors: ( at US_FDA) Source Type: news

#FDA issues updated information on Breast Implant Associated-Anaplastic Large Cell Lymphoma (BIA-ALCL). Know and consider the risks. https://go.usa.gov/xQxxs   #MedicalDevice
#FDA issues updated information on Breast Implant Associated-Anaplastic Large Cell Lymphoma (BIA-ALCL). Know and consider the risks. https://go.usa.gov/xQxxs  #MedicalDevice (Source: Food and Drug Adminstration (FDA): CDRHNew)
Source: Food and Drug Adminstration (FDA): CDRHNew - March 21, 2018 Category: Medical Devices Authors: ( at FDADeviceInfo) Source Type: news

Traumatic brain injury (TBI), which includes concussions, can happen to anyone. Learn the symptoms & what to do if you suspect one. #BrainInjuryAwarenessMonth https://go.usa.gov/xQcGd   pic.twitter.com/NSmcWfrCsU
Traumatic brain injury (TBI), which includes concussions, can happen to anyone. Learn the symptoms & what to do if you suspect one. #BrainInjuryAwarenessMonth https://go.usa.gov/xQcGd  pic.twitter.com/NSmcWfrCsU (Source: Food and Drug Adminstration (FDA): CDRHNew)
Source: Food and Drug Adminstration (FDA): CDRHNew - March 20, 2018 Category: Medical Devices Authors: ( at US_FDA) Source Type: news

#OnThisDay: March 19, 1984- The National Center for Devices and Radiological Health was renamed the Center for Devices and Radiological Health #DidYouKnow #FDAHistory
(Source: Food and Drug Adminstration (FDA): CDRHNew)
Source: Food and Drug Adminstration (FDA): CDRHNew - March 19, 2018 Category: Medical Devices Authors: ( at FDADeviceInfo) Source Type: news

#DidYouKnow- March 16th is World Sleep Day. According to the American Sleep Association, Obstructive Sleep Apnea affects almost 29 million Americans. Click the link for more information https://aasm.org/about/patient-info/   … #MedicalDevice #FunFactFridaypic.twitter.com/vfBz8mPHAz
#DidYouKnow- March 16th is World Sleep Day. According to the American Sleep Association, Obstructive Sleep Apnea affects almost 29 million Americans. Click the link for more information https://aasm.org/about/patient-info/ … #MedicalDevice #FunFactFriday pic.twitter.com/vfBz8mPHAz (Source: Food and Drug Adminstration (FDA): CDRHNew)
Source: Food and Drug Adminstration (FDA): CDRHNew - March 16, 2018 Category: Medical Devices Authors: ( at FDADeviceInfo) Source Type: news

Join us for UMD CERSI and FDA's workshop #PatientEngagement in the National Evaluation System for Health Technology #NEST on 3/22 https://go.usa.gov/xQqpZ  
Join us for UMD CERSI and FDA's workshop #PatientEngagement in the National Evaluation System for Health Technology #NEST on 3/22 https://go.usa.gov/xQqpZ  (Source: Food and Drug Adminstration (FDA): CDRHNew)
Source: Food and Drug Adminstration (FDA): CDRHNew - March 15, 2018 Category: Medical Devices Authors: ( at FDADeviceInfo) Source Type: news

#ICYMI #DidYouKnow -March 9th was #FalseTeethDay? Check out the FDA ’ s information about denture adhesives and advice for denture wearers- https://go.usa.gov/xQq5W   #MedicalDevicepic.twitter.com/J5GrTuFXeK
#ICYMI #DidYouKnow -March 9th was #FalseTeethDay? Check out the FDA’s information about denture adhesives and advice for denture wearers- https://go.usa.gov/xQq5W  #MedicalDevice pic.twitter.com/J5GrTuFXeK (Source: Food and Drug Adminstration (FDA): CDRHNew)
Source: Food and Drug Adminstration (FDA): CDRHNew - March 15, 2018 Category: Medical Devices Authors: ( at FDADeviceInfo) Source Type: news

FDA provides new information about medical device reports related to #Essure from 2017 https://go.usa.gov/xnJ5F   #MedicalDevice
FDA provides new information about medical device reports related to #Essure from 2017 https://go.usa.gov/xnJ5F  #MedicalDevice (Source: Food and Drug Adminstration (FDA): CDRHNew)
Source: Food and Drug Adminstration (FDA): CDRHNew - March 7, 2018 Category: Medical Devices Authors: ( at FDADeviceInfo) Source Type: news

#DidYouKnow https://twitter.com/CDC_NCEZID/status/971454707146387456   …
#DidYouKnow https://twitter.com/CDC_NCEZID/status/971454707146387456 … (Source: Food and Drug Adminstration (FDA): CDRHNew)
Source: Food and Drug Adminstration (FDA): CDRHNew - March 7, 2018 Category: Medical Devices Authors: ( at FDADeviceInfo) Source Type: news

FDA expands approval of replacement heart valve, smallest mechanical valve size approved in the world. Size is small enough to be used in newborn pediatric patients to treat heart defects https://go.usa.gov/xnutA   #MedicalDevicepic.twitter.com/ec0qp5qotN
FDA expands approval of replacement heart valve, smallest mechanical valve size approved in the world. Size is small enough to be used in newborn pediatric patients to treat heart defects https://go.usa.gov/xnutA  #MedicalDevice pic.twitter.com/ec0qp5qotN (Source: Food and Drug Adminstration (FDA): CDRHNew)
Source: Food and Drug Adminstration (FDA): CDRHNew - March 6, 2018 Category: Medical Devices Authors: ( at FDADeviceInfo) Source Type: news

FDA authorizes, w/ special controls, direct-to-consumer test that reports three mutations in the BRCA breast cancer genes. Test only reports 3 out of more than 1,000 known BRCA mutations & negative result doesn ’ t rule out increased cancer risk https://go.usa.gov/xnuGN  
FDA authorizes, w/ special controls, direct-to-consumer test that reports three mutations in the BRCA breast cancer genes. Test only reports 3 out of more than 1,000 known BRCA mutations & negative result doesn’t rule out increased cancer risk https://go.usa.gov/xnuGN  (Source: Food and Drug Adminstration (FDA): CDRHNew)
Source: Food and Drug Adminstration (FDA): CDRHNew - March 6, 2018 Category: Medical Devices Authors: ( at US_FDA) Source Type: news

Consumer Information: BD Onclarity HPV Assay - P160037 https://go.usa.gov/xnza4   #MedicalDevice
Consumer Information: BD Onclarity HPV Assay - P160037 https://go.usa.gov/xnza4  #MedicalDevice (Source: Food and Drug Adminstration (FDA): CDRHNew)
Source: Food and Drug Adminstration (FDA): CDRHNew - March 2, 2018 Category: Medical Devices Authors: ( at FDADeviceInfo) Source Type: news

Advisory Committee Meeting Notice: March 29-30, 2018 - Clinical Chemistry and Clinical Toxicology Devices Panel of the Medical Devices Advisory Committee https://go.usa.gov/xnzaC   #MedicalDevice
Advisory Committee Meeting Notice: March 29-30, 2018 - Clinical Chemistry and Clinical Toxicology Devices Panel of the Medical Devices Advisory Committee https://go.usa.gov/xnzaC  #MedicalDevice (Source: Food and Drug Adminstration (FDA): CDRHNew)
Source: Food and Drug Adminstration (FDA): CDRHNew - March 2, 2018 Category: Medical Devices Authors: ( at FDADeviceInfo) Source Type: news

When diverse women participate in clinical trials, researchers better understand the treatments & conditions that affect a diverse population. Ask your healthcare provider if a #clinicaltrial is right for you: http://go.usa.gov/xXNew   pic.twitter.com/Uc6SLQBdNj
When diverse women participate in clinical trials, researchers better understand the treatments & conditions that affect a diverse population. Ask your healthcare provider if a #clinicaltrial is right for you: http://go.usa.gov/xXNew  pic.twitter.com/Uc6SLQBdNj (Source: Food and Drug Adminstration (FDA): CDRHNew)
Source: Food and Drug Adminstration (FDA): CDRHNew - March 2, 2018 Category: Medical Devices Authors: ( at FDAWomen) Source Type: news

Consumer Information: Impella Ventricular Support Systems - P140003/S018 https://go.usa.gov/xnzxu   #MedicalDevice
Consumer Information: Impella Ventricular Support Systems - P140003/S018 https://go.usa.gov/xnzxu  #MedicalDevice (Source: Food and Drug Adminstration (FDA): CDRHNew)
Source: Food and Drug Adminstration (FDA): CDRHNew - March 2, 2018 Category: Medical Devices Authors: ( at FDADeviceInfo) Source Type: news

FDA Voice Blog: Brain Implant for Some Blind People Shows Benefits of FDA ’ s Breakthrough Device Program https://go.usa.gov/xnzx7  
FDA Voice Blog: Brain Implant for Some Blind People Shows Benefits of FDA’s Breakthrough Device Program https://go.usa.gov/xnzx7  (Source: Food and Drug Adminstration (FDA): CDRHNew)
Source: Food and Drug Adminstration (FDA): CDRHNew - March 2, 2018 Category: Medical Devices Authors: ( at FDADeviceInfo) Source Type: news

Class I Medical Device Recall: Medtronic Recalls Cardiac Resynchronization Therapy and Implantable Cardioverter Defibrillators Due to Manufacturing Error Preventing Electrical Shock Delivery https://go.usa.gov/xnzxy   #MedicalDevice
Class I Medical Device Recall: Medtronic Recalls Cardiac Resynchronization Therapy and Implantable Cardioverter Defibrillators Due to Manufacturing Error Preventing Electrical Shock Delivery https://go.usa.gov/xnzxy  #MedicalDevice (Source: Food and Drug Adminstration (FDA): CDRHNew)
Source: Food and Drug Adminstration (FDA): CDRHNew - March 1, 2018 Category: Medical Devices Authors: ( at FDADeviceInfo) Source Type: news

Meeting Notice- March 21-22, 2018: Joint Meeting of the Blood Products Advisory Committee and the Microbiology Devices Panel of the Medical Devices Advisory Committee Meeting Announcement https://go.usa.gov/xnzxK   #MedicalDevice
Meeting Notice- March 21-22, 2018: Joint Meeting of the Blood Products Advisory Committee and the Microbiology Devices Panel of the Medical Devices Advisory Committee Meeting Announcement https://go.usa.gov/xnzxK  #MedicalDevice (Source: Food and Drug Adminstration (FDA): CDRHNew)
Source: Food and Drug Adminstration (FDA): CDRHNew - March 1, 2018 Category: Medical Devices Authors: ( at FDADeviceInfo) Source Type: news

Public Workshop - Patient Engagement in the National Evaluation System for health Technology (NEST): Lessons Learned and Best Practices Workshop Announcement, March 22, 2018 https://go.usa.gov/xnzxj  
Public Workshop - Patient Engagement in the National Evaluation System for health Technology (NEST): Lessons Learned and Best Practices Workshop Announcement, March 22, 2018 https://go.usa.gov/xnzxj  (Source: Food and Drug Adminstration (FDA): CDRHNew)
Source: Food and Drug Adminstration (FDA): CDRHNew - March 1, 2018 Category: Medical Devices Authors: ( at FDADeviceInfo) Source Type: news

March is #WomensHistoryMonth! We are excited to celebrate #FDA trailblazers who have made a difference in women ’ s health. https://go.usa.gov/xntbb   #TBTpic.twitter.com/ZxyupdywaZ
March is #WomensHistoryMonth ! We are excited to celebrate #FDA trailblazers who have made a difference in women’s health. https://go.usa.gov/xntbb  #TBT pic.twitter.com/ZxyupdywaZ (Source: Food and Drug Adminstration (FDA): CDRHNew)
Source: Food and Drug Adminstration (FDA): CDRHNew - March 1, 2018 Category: Medical Devices Authors: ( at FDAWomen) Source Type: news

We have developed a series of new videos and other materials that explain the scope of what FDA is doing to encourage the development of medical products for rare diseases. We invite you to take a look: https://go.usa.gov/xnefq   #rarediseasedaypic.twitter.com/yHQEImwUEd
We have developed a series of new videos and other materials that explain the scope of what FDA is doing to encourage the development of medical products for rare diseases. We invite you to take a look: https://go.usa.gov/xnefq  #rarediseaseday pic.twitter.com/yHQEImwUEd (Source: Food and Drug Adminstration (FDA): CDRHNew)
Source: Food and Drug Adminstration (FDA): CDRHNew - February 26, 2018 Category: Medical Devices Authors: ( at US_FDA) Source Type: news

Presentation Slides added to Public Workshop - Fostering Digital Health Innovation: Developing the Software Precertification Program - January 30-31, 2018 https://go.usa.gov/xnerK   #FDAPrecert #MedicalDevice #DigitalHealth
Presentation Slides added to Public Workshop - Fostering Digital Health Innovation: Developing the Software Precertification Program - January 30-31, 2018 https://go.usa.gov/xnerK  #FDAPrecert #MedicalDevice #DigitalHealth (Source: Food and Drug Adminstration (FDA): CDRHNew)
Source: Food and Drug Adminstration (FDA): CDRHNew - February 23, 2018 Category: Medical Devices Authors: ( at FDADeviceInfo) Source Type: news

Public Meeting - Pediatric Medical Device Development - August 13-14, 2018, FDA White Oak Campus https://go.usa.gov/xnerb   #FDA #MedicalDevice
Public Meeting - Pediatric Medical Device Development - August 13-14, 2018, FDA White Oak Campus https://go.usa.gov/xnerb  #FDA #MedicalDevice (Source: Food and Drug Adminstration (FDA): CDRHNew)
Source: Food and Drug Adminstration (FDA): CDRHNew - February 23, 2018 Category: Medical Devices Authors: ( at FDADeviceInfo) Source Type: news

#DidYouKnow Find out more about FDA approved devices that keep the heart beating http://go.usa.gov/xne3G   #HeartMonthpic.twitter.com/AaVz9DxOMa
#DidYouKnow Find out more about FDA approved devices that keep the heart beating http://go.usa.gov/xne3G  #HeartMonth pic.twitter.com/AaVz9DxOMa (Source: Food and Drug Adminstration (FDA): CDRHNew)
Source: Food and Drug Adminstration (FDA): CDRHNew - February 23, 2018 Category: Medical Devices Authors: ( at FDADeviceInfo) Source Type: news

Mark your calendars for #PatientEngagement in the National Evaluation System for Health Technology (NEST) one-day workshop sponsored by the UMD CERSI & FDA. Click the link for more info: https://goo.gl/CqZF4k   #NEST #MedicalDevice #safety
Mark your calendars for #PatientEngagement in the National Evaluation System for Health Technology (NEST) one-day workshop sponsored by the UMD CERSI & FDA. Click the link for more info: https://goo.gl/CqZF4k  #NEST #MedicalDevice #safety (Source: Food and Drug Adminstration (FDA): CDRHNew)
Source: Food and Drug Adminstration (FDA): CDRHNew - February 22, 2018 Category: Medical Devices Authors: ( at FDADeviceInfo) Source Type: news

Recently Approved Device- Consumer Information on: Aptima HBV Quant assay - P170025 https://go.usa.gov/xnF3d   #MedicalDevice
Recently Approved Device- Consumer Information on: Aptima HBV Quant assay - P170025 https://go.usa.gov/xnF3d  #MedicalDevice (Source: Food and Drug Adminstration (FDA): CDRHNew)
Source: Food and Drug Adminstration (FDA): CDRHNew - February 15, 2018 Category: Medical Devices Authors: ( at FDADeviceInfo) Source Type: news

MSQA Insights- Direct-to-Patient Mammogram Results: It ’ s the Law- https://go.usa.gov/xnF3E   #MedicalDevice
MSQA Insights- Direct-to-Patient Mammogram Results: It’s the Law- https://go.usa.gov/xnF3E  #MedicalDevice (Source: Food and Drug Adminstration (FDA): CDRHNew)
Source: Food and Drug Adminstration (FDA): CDRHNew - February 15, 2018 Category: Medical Devices Authors: ( at FDADeviceInfo) Source Type: news

FDA authorizes marketing of 1st blood test to aid in eval of concussion in adults. Most patients eval'd for concussion w/ a CT scan don't have detectable brain tissue damage. This quick testing option helps reduce the need for CT scans, radiation exposure https://go.usa.gov/xnFxq   pic.twitter.com/srv921peN7
FDA authorizes marketing of 1st blood test to aid in eval of concussion in adults. Most patients eval'd for concussion w/ a CT scan don't have detectable brain tissue damage. This quick testing option helps reduce the need for CT scans, radiation exposure https://go.usa.gov/xnFxq  pic.twitter.com/srv921peN7 (Source: Food and Drug Adminstration (FDA): CDRHNew)
Source: Food and Drug Adminstration (FDA): CDRHNew - February 15, 2018 Category: Medical Devices Authors: ( at FDADeviceInfo) Source Type: news

FDA authorizes marketing of 1st blood test to aid in eval of concussion in adults. Most patients eval'd for concussion w/ a CT scan don't have detectable brain tissue damage. This quick testing option helps reduce the need for CT scans, radiation exposure https://go.usa.gov/xn6vh   pic.twitter.com/QQzznfsvmI
FDA authorizes marketing of 1st blood test to aid in eval of concussion in adults. Most patients eval'd for concussion w/ a CT scan don't have detectable brain tissue damage. This quick testing option helps reduce the need for CT scans, radiation exposure https://go.usa.gov/xn6vh  pic.twitter.com/QQzznfsvmI (Source: Food and Drug Adminstration (FDA): CDRHNew)
Source: Food and Drug Adminstration (FDA): CDRHNew - February 14, 2018 Category: Medical Devices Authors: ( at US_FDA) Source Type: news

#DidYouKnow https://twitter.com/FDATobacco/status/963457773462843392   …
#DidYouKnow https://twitter.com/FDATobacco/status/963457773462843392 … (Source: Food and Drug Adminstration (FDA): CDRHNew)
Source: Food and Drug Adminstration (FDA): CDRHNew - February 13, 2018 Category: Medical Devices Authors: ( at FDADeviceInfo) Source Type: news

FDA adds new information about warfarin INR test meters to FDA website to help patients, caregivers, and health care providers use these devices safely and effectively. https://go.usa.gov/xnHFk   #MedicalDevice
FDA adds new information about warfarin INR test meters to FDA website to help patients, caregivers, and health care providers use these devices safely and effectively. https://go.usa.gov/xnHFk  #MedicalDevice (Source: Food and Drug Adminstration (FDA): CDRHNew)
Source: Food and Drug Adminstration (FDA): CDRHNew - February 12, 2018 Category: Medical Devices Authors: ( at FDADeviceInfo) Source Type: news

#DidYouKnow https://twitter.com/SGottliebFDA/status/961378031020531713   …
#DidYouKnow https://twitter.com/SGottliebFDA/status/961378031020531713 … (Source: Food and Drug Adminstration (FDA): CDRHNew)
Source: Food and Drug Adminstration (FDA): CDRHNew - February 9, 2018 Category: Medical Devices Authors: ( at FDADeviceInfo) Source Type: news

Higher performance standards help lower misdiagnoses with antigen-based #flu tests – https://go.usa.gov/xnH8M  
Higher performance standards help lower misdiagnoses with antigen-based #flu tests – https://go.usa.gov/xnH8M  (Source: Food and Drug Adminstration (FDA): CDRHNew)
Source: Food and Drug Adminstration (FDA): CDRHNew - February 9, 2018 Category: Medical Devices Authors: ( at FDADeviceInfo) Source Type: news

No Nationwide Shortage: 13 rapid #flu tests available showing acceptable clinical performance https://go.usa.gov/xnH4R   pic.twitter.com/UbFUmNclJ3
No Nationwide Shortage: 13 rapid #flu tests available showing acceptable clinical performance https://go.usa.gov/xnH4R  pic.twitter.com/UbFUmNclJ3 (Source: Food and Drug Adminstration (FDA): CDRHNew)
Source: Food and Drug Adminstration (FDA): CDRHNew - February 9, 2018 Category: Medical Devices Authors: ( at FDADeviceInfo) Source Type: news

FDA Letter to Health Care Providers: Death and Pulmonary Embolism Related to Extracorporeal Photopheresis (ECP) Treatment https://go.usa.gov/xnHCy   #MedicalDevice
FDA Letter to Health Care Providers: Death and Pulmonary Embolism Related to Extracorporeal Photopheresis (ECP) Treatment https://go.usa.gov/xnHCy  #MedicalDevice (Source: Food and Drug Adminstration (FDA): CDRHNew)
Source: Food and Drug Adminstration (FDA): CDRHNew - February 8, 2018 Category: Medical Devices Authors: ( at FDADeviceInfo) Source Type: news

CDRH's Bakul Patel talks #DigitalHealth and #FDAPrecert today at 10:15am with entrepreneurs, innovators and startups http://bit.ly/HHSStartupDay   #HHSstartupday
CDRH's Bakul Patel talks #DigitalHealth and #FDAPrecert today at 10:15am with entrepreneurs, innovators and startups http://bit.ly/HHSStartupDay  #HHSstartupday (Source: Food and Drug Adminstration (FDA): CDRHNew)
Source: Food and Drug Adminstration (FDA): CDRHNew - February 5, 2018 Category: Medical Devices Authors: ( at FDADeviceInfo) Source Type: news

Despite reports that this year ’ s flu vaccine shows diminished efficacy against the predominant H3N2 strain, a vaccine is still your best bet. As in past years, we ’ re seeing an increase in H1N1 relative to H3N2 as the season progresses; and vaccine efficacy against H1N1 is goodpic.twitter.com/SG8sq2tE77
Despite reports that this year’s flu vaccine shows diminished efficacy against the predominant H3N2 strain, a vaccine is still your best bet. As in past years, we’re seeing an increase in H1N1 relative to H3N2 as the season progresses; and vaccine efficacy against H1N1 is good pic.twitter.com/SG8sq2tE77 (Source: Food and Drug Adminstration (FDA): CDRHNew)
Source: Food and Drug Adminstration (FDA): CDRHNew - February 5, 2018 Category: Medical Devices Authors: ( at SGottliebFDA) Source Type: news

#FDA has seen reports of spot shortages of flu related antiviral drugs, where an individual pharmacy may be out of drug. But there ’ s ample overall supply and no drug shortage. If you have flu-like symptoms please consult your doctor for treatment options http://go.usa.gov/xn7uW   pic.twitter.com/4Pl109GN2O
#FDA has seen reports of spot shortages of flu related antiviral drugs, where an individual pharmacy may be out of drug. But there’s ample overall supply and no drug shortage. If you have flu-like symptoms please consult your doctor for treatment options http://go.usa.gov/xn7uW  pic.twitter.com/4Pl109GN2O (Source: Food and Drug Adminstration (FDA): CDRHNew)
Source: Food and Drug Adminstration (FDA): CDRHNew - February 4, 2018 Category: Medical Devices Authors: ( at SGottliebFDA) Source Type: news

While early indications are that flu vaccines may not be as effective against the H3N2 strain this year as previous flu seasons, the best protection still is to get vaccinated. It also protects against other strains circulating this year besides H3N2: http://go.usa.gov/xnAgz   pic.twitter.com/mgakpQKoia
While early indications are that flu vaccines may not be as effective against the H3N2 strain this year as previous flu seasons, the best protection still is to get vaccinated. It also protects against other strains circulating this year besides H3N2: http://go.usa.gov/xnAgz  pic.twitter.com/mgakpQKoia (Source: Food and Drug Adminstration (FDA): CDRHNew)
Source: Food and Drug Adminstration (FDA): CDRHNew - February 4, 2018 Category: Medical Devices Authors: ( at SGottliebFDA) Source Type: news

FDA Identified Class I Recall: Vyaire Medical Recalls AirLife Humidification Chamber & Heated Breathing Circuit Kits Due to Manufacturing Error https://go.usa.gov/xn7FG   #MedicalDevice
FDA Identified Class I Recall: Vyaire Medical Recalls AirLife Humidification Chamber & Heated Breathing Circuit Kits Due to Manufacturing Error https://go.usa.gov/xn7FG  #MedicalDevice (Source: Food and Drug Adminstration (FDA): CDRHNew)
Source: Food and Drug Adminstration (FDA): CDRHNew - February 1, 2018 Category: Medical Devices Authors: ( at FDADeviceInfo) Source Type: news

Continue the conversation about #DigitalHealth with FDA. Send your comments to the docket https://go.usa.gov/xn7gb   #MedicalDevice #FDAPrecert
Continue the conversation about #DigitalHealth with FDA. Send your comments to the docket https://go.usa.gov/xn7gb  #MedicalDevice #FDAPrecert (Source: Food and Drug Adminstration (FDA): CDRHNew)
Source: Food and Drug Adminstration (FDA): CDRHNew - January 31, 2018 Category: Medical Devices Authors: ( at FDADeviceInfo) Source Type: news

FDA discusses data aggregation tools for #DigitalHealth with DH technology and medical device companies https://go.usa.gov/xn7gY   #MedicalDevice #FDAPrecert
FDA discusses data aggregation tools for #DigitalHealth with DH technology and medical device companies https://go.usa.gov/xn7gY  #MedicalDevice #FDAPrecert (Source: Food and Drug Adminstration (FDA): CDRHNew)
Source: Food and Drug Adminstration (FDA): CDRHNew - January 31, 2018 Category: Medical Devices Authors: ( at FDADeviceInfo) Source Type: news

Bakul Patel talks modernizing regulatory structures while preserving standards of safety and effectiveness for #DigitalHealth tech https://go.usa.gov/xn7gx   #MedicalDevice #FDAPrecert
Bakul Patel talks modernizing regulatory structures while preserving standards of safety and effectiveness for #DigitalHealth tech https://go.usa.gov/xn7gx  #MedicalDevice #FDAPrecert (Source: Food and Drug Adminstration (FDA): CDRHNew)
Source: Food and Drug Adminstration (FDA): CDRHNew - January 31, 2018 Category: Medical Devices Authors: ( at FDADeviceInfo) Source Type: news