Today, the @US_FDA issued a draft guidance on Magnetic Resonance Coils related to the Safety & Performance Based Pathway as part of our commitment to strengthening & modernizing the 510(k) program, as described in the FDA ’ s Medical Device Safety Action Plan. https://go.usa.gov/xpmuK   pic.twitter.com/XrgC0wvhbP
Today, the @US_FDA issued a draft guidance on Magnetic Resonance Coils related to the Safety&Performance Based Pathway as part of our commitment to strengthening & modernizing the 510(k) program, as described in the FDA’s Medical Device Safety Action Plan. https://go.usa.gov/xpmuK  pic.twitter.com/XrgC0wvhbP (Source: Food and Drug Adminstration (FDA): CDRHNew)
Source: Food and Drug Adminstration (FDA): CDRHNew - December 6, 2019 Category: Medical Devices Authors: ( at FDADeviceInfo) Source Type: news

For more information, please visit our “ Framework for the Safety and Performance Based Pathway ” page: https://go.usa.gov/xpmuR  
For more information, please visit our “Framework for the Safety and Performance Based Pathway” page: https://go.usa.gov/xpmuR  (Source: Food and Drug Adminstration (FDA): CDRHNew)
Source: Food and Drug Adminstration (FDA): CDRHNew - December 6, 2019 Category: Medical Devices Authors: ( at FDADeviceInfo) Source Type: news

December is #SafeToysAndGiftsMonth. With holiday shopping in full gear, the @US_FDA wants to remind consumers about ways to keep kids safe from toys with lasers. Check out our consumer update on laser toy safety. https://go.usa.gov/xEx2r   #FDA
December is #SafeToysAndGiftsMonth. With holiday shopping in full gear, the @US_FDA wants to remind consumers about ways to keep kids safe from toys with lasers. Check out our consumer update on laser toy safety. https://go.usa.gov/xEx2r  #FDA (Source: Food and Drug Adminstration (FDA): CDRHNew)
Source: Food and Drug Adminstration (FDA): CDRHNew - December 5, 2019 Category: Medical Devices Authors: ( at FDADeviceInfo) Source Type: news

JUST RELEASED: Our Case for Quality program offers a new whitepaper recasting CAPA as a continuous improvement process. Learn more: http://bit.ly/2LleyZs   pic.twitter.com/I72EouNT8C
JUST RELEASED: Our Case for Quality program offers a new whitepaper recasting CAPA as a continuous improvement process. Learn more: http://bit.ly/2LleyZs  pic.twitter.com/I72EouNT8C (Source: Food and Drug Adminstration (FDA): CDRHNew)
Source: Food and Drug Adminstration (FDA): CDRHNew - December 3, 2019 Category: Medical Devices Authors: ( at MDIConline) Source Type: news

It ’ s National Influenza Vaccination Week — time to highlight the importance flu vaccination! Even though the holiday season has begun, it ’ s not too late to get a flu vaccine. Protect yourself and your loved ones this flu season. #NIVW #FightFlu https://cdc.gov/flu/prevent/keyfacts.htm   … pic.twitter.com/X20vNIK1zx
It’s National Influenza Vaccination Week— time to highlight the importance flu vaccination! Even though the holiday season has begun, it’s not too late to get a flu vaccine. Protect yourself and your loved ones this flu season. #NIVW #FightFlu https://cdc.gov/flu/prevent/keyfacts.htm … pic.twitter.com/X20vNIK1zx (Source: Food and Drug Adminstration (FDA): CDRHNew)
Source: Food and Drug Adminstration (FDA): CDRHNew - December 3, 2019 Category: Medical Devices Authors: ( at FDAHealthEquity) Source Type: news

When operated unsafely, or without certain controls, the highly-concentrated light from lasers — even those in toys — can be dangerous. Learn more about how FDA regulates lasers: https://go.usa.gov/xpP3n   #SafeToysandCelebrationsMonth pic.twitter.com/Z2kNcQ9icH
When operated unsafely, or without certain controls, the highly-concentrated light from lasers — even those in toys — can be dangerous. Learn more about how FDA regulates lasers: https://go.usa.gov/xpP3n  #SafeToysandCelebrationsMonth pic.twitter.com/Z2kNcQ9icH (Source: Food and Drug Adminstration (FDA): CDRHNew)
Source: Food and Drug Adminstration (FDA): CDRHNew - December 3, 2019 Category: Medical Devices Authors: ( at US_FDA) Source Type: news

• Key dates: oJanuary 10, 2020 - Request to make oral presentations oFebruary 12, 2020 - Register to attend the workshop oMarch 26, 2020 - Submit written comments Find out more about the upcoming meeting: https://go.usa.gov/xpPCS  
•Key dates: oJanuary 10, 2020 - Request to make oral presentations oFebruary 12, 2020 - Register to attend the workshop oMarch 26, 2020 - Submit written comments Find out more about the upcoming meeting: https://go.usa.gov/xpPCS  (Source: Food and Drug Adminstration (FDA): CDRHNew)
Source: Food and Drug Adminstration (FDA): CDRHNew - December 2, 2019 Category: Medical Devices Authors: ( at FDADeviceInfo) Source Type: news

On February 25th and 26th, the @US_FDA will host a public workshop, “ Evolving Role of Artificial Intelligence in Radiological Imaging. ” pic.twitter.com/mPoF1nM9vG
On February 25th and 26th, the @US_FDA will host a public workshop, “Evolving Role of Artificial Intelligence in Radiological Imaging.” pic.twitter.com/mPoF1nM9vG (Source: Food and Drug Adminstration (FDA): CDRHNew)
Source: Food and Drug Adminstration (FDA): CDRHNew - December 2, 2019 Category: Medical Devices Authors: ( at FDADeviceInfo) Source Type: news

The intent of this public workshop is to discuss emerging applications of Artificial Intelligence (AI) in radiological imaging including AI devices intended to automate the diagnostic radiology workflow as well as guided image acquisition.
(Source: Food and Drug Adminstration (FDA): CDRHNew)
Source: Food and Drug Adminstration (FDA): CDRHNew - December 2, 2019 Category: Medical Devices Authors: ( at FDADeviceInfo) Source Type: news

Artificial intelligence (AI), including machine learning technologies, continues to expand and has the potential to transform healthcare.
(Source: Food and Drug Adminstration (FDA): CDRHNew)
Source: Food and Drug Adminstration (FDA): CDRHNew - December 2, 2019 Category: Medical Devices Authors: ( at FDADeviceInfo) Source Type: news

Shopping from your couch on #CyberMonday? Check out these easy ways to get the whole family moving today! (via @CDCgov) https://go.usa.gov/xpQsC   pic.twitter.com/S5h3pQAH59
Shopping from your couch on #CyberMonday? Check out these easy ways to get the whole family moving today! (via @CDCgov) https://go.usa.gov/xpQsC  pic.twitter.com/S5h3pQAH59 (Source: Food and Drug Adminstration (FDA): CDRHNew)
Source: Food and Drug Adminstration (FDA): CDRHNew - December 2, 2019 Category: Medical Devices Authors: ( at US_FDA) Source Type: news

Parties, family dinners, and other gatherings where food is served are all part of the holiday cheer. But the merriment can change to misery if food makes you or others ill. Here are our " Food Safety Tips for Healthy Holidays. " https://www.fda.gov/consumers/consumer-updates/food-safety-tips-healthy-holidays   …
Parties, family dinners, and other gatherings where food is served are all part of the holiday cheer. But the merriment can change to misery if food makes you or others ill. Here are our "Food Safety Tips for Healthy Holidays." https://www.fda.gov/consumers/consumer-updates/food-safety-tips-healthy-holidays … (Source: Food and Drug Adminstration (FDA): CDRHNew)
Source: Food and Drug Adminstration (FDA): CDRHNew - November 27, 2019 Category: Medical Devices Authors: ( at US_FDA) Source Type: news

During #DiabetesAwarenessMonth, the @US_FDA is reminding people with diabetes against the use of diabetes management devices that are not authorized for sale in the US. Stay informed and find out more: https://go.usa.gov/xpBJC  
During #DiabetesAwarenessMonth, the @US_FDA is reminding people with diabetes against the use of diabetes management devices that are not authorized for sale in the US. Stay informed and find out more: https://go.usa.gov/xpBJC  (Source: Food and Drug Adminstration (FDA): CDRHNew)
Source: Food and Drug Adminstration (FDA): CDRHNew - November 27, 2019 Category: Medical Devices Authors: ( at FDADeviceInfo) Source Type: news

http://HIV.gov   - World AIDS Day #WAD2019http://www.hiv.gov/events/awareness-days/world-aids-day   …
http://HIV.gov  - World AIDS Day #WAD2019 http://www.hiv.gov/events/awareness-days/world-aids-day … (Source: Food and Drug Adminstration (FDA): CDRHNew)
Source: Food and Drug Adminstration (FDA): CDRHNew - November 26, 2019 Category: Medical Devices Authors: ( at HHSRegion6) Source Type: news

Did you know that you can use your smartphone to access your health records? Learn what #APIs are and how they support #PatientAccess: https://www.healthit.gov/api-education-module/story_html5.html   … #HealthITpic.twitter.com/l8zf52vUYe
Did you know that you can use your smartphone to access your health records? Learn what #APIs are and how they support #PatientAccess: https://www.healthit.gov/api-education-module/story_html5.html … #HealthIT pic.twitter.com/l8zf52vUYe (Source: Food and Drug Adminstration (FDA): CDRHNew)
Source: Food and Drug Adminstration (FDA): CDRHNew - November 26, 2019 Category: Medical Devices Authors: ( at ONC_HealthIT) Source Type: news

FDA has approved first system for delivery of tympanostomy tubes, commonly referred to as ear tubes, that can be used w/local anesthesia to treat recurrent ear infections in children.
(Source: Food and Drug Adminstration (FDA): CDRHNew)
Source: Food and Drug Adminstration (FDA): CDRHNew - November 26, 2019 Category: Medical Devices Authors: ( at FDAMedia) Source Type: news

We ’ re also moving fwd on recs from our Nov. public mtg on EtO sterilization of devices & its role in public health. Read the summary of discussion w/ speakers from the @US_FDA, @EPA, @CDCgov, @MHRAgovuk, several other stakeholders, & members of the public https://go.usa.gov/xpR2G  
We’re also moving fwd on recs from our Nov. public mtg on EtO sterilization of devices & its role in public health. Read the summary of discussion w/ speakers from the @US_FDA, @EPA, @CDCgov, @MHRAgovuk, several other stakeholders, & members of the public https://go.usa.gov/xpR2G  (Source: Food and Drug Adminstration (FDA): CDRHNew)
Source: Food and Drug Adminstration (FDA): CDRHNew - November 25, 2019 Category: Medical Devices Authors: ( at FDADeviceInfo) Source Type: news

In an effort to expedite approvals of certain changes to EtO sterilization processes and facilities, we announced & are asking for participation in a voluntary Ethylene Oxide Sterilization Master File Pilot Program. Learn more: https://federalregister.gov/d/2019-25631  
In an effort to expedite approvals of certain changes to EtO sterilization processes and facilities, we announced & are asking for participation in a voluntary Ethylene Oxide Sterilization Master File Pilot Program. Learn more: https://federalregister.gov/d/2019-25631  (Source: Food and Drug Adminstration (FDA): CDRHNew)
Source: Food and Drug Adminstration (FDA): CDRHNew - November 25, 2019 Category: Medical Devices Authors: ( at FDADeviceInfo) Source Type: news

We ’ re pleased to announce the results of two recent #fdainnovationchallenge to identify sterilization alternatives and reduce ethylene oxide (EtO) emissions. Read more about the challenges and selected applications. https://go.usa.gov/xpR28  
We’re pleased to announce the results of two recent #fdainnovationchallenge to identify sterilization alternatives and reduce ethylene oxide (EtO) emissions. Read more about the challenges and selected applications. https://go.usa.gov/xpR28  (Source: Food and Drug Adminstration (FDA): CDRHNew)
Source: Food and Drug Adminstration (FDA): CDRHNew - November 25, 2019 Category: Medical Devices Authors: ( at FDADeviceInfo) Source Type: news

We just announced the next steps in our ongoing efforts in medical device sterilization with ethylene oxide.
(Source: Food and Drug Adminstration (FDA): CDRHNew)
Source: Food and Drug Adminstration (FDA): CDRHNew - November 25, 2019 Category: Medical Devices Authors: ( at FDADeviceInfo) Source Type: news

Today, the FDA issued a statement on new steps to advance innovation in medical device sterilization with ethylene oxide. https://go.usa.gov/xpNh3   pic.twitter.com/ZQ5fa6bwFS
Today, the FDA issued a statement on new steps to advance innovation in medical device sterilization with ethylene oxide. https://go.usa.gov/xpNh3  pic.twitter.com/ZQ5fa6bwFS (Source: Food and Drug Adminstration (FDA): CDRHNew)
Source: Food and Drug Adminstration (FDA): CDRHNew - November 25, 2019 Category: Medical Devices Authors: ( at FDAMedia) Source Type: news

In recognition of #DiabetesAwarenessMonth, the @US_FDA continues to warn against the use of previously owned test strips or test strips not authorized for sale in the United States https://go.usa.gov/xpjZs  
In recognition of #DiabetesAwarenessMonth, the @US_FDA continues to warn against the use of previously owned test strips or test strips not authorized for sale in the United States https://go.usa.gov/xpjZs  (Source: Food and Drug Adminstration (FDA): CDRHNew)
Source: Food and Drug Adminstration (FDA): CDRHNew - November 22, 2019 Category: Medical Devices Authors: ( at FDADeviceInfo) Source Type: news

#DYK 1 in 3 adults has prediabetes? This #NationalDiabetesAwarenessMonth, take the test to find out if you are at risk: http://DoIhavePrediabetes.org   pic.twitter.com/AlpeK11qZv
#DYK 1 in 3 adults has prediabetes? This #NationalDiabetesAwarenessMonth, take the test to find out if you are at risk: http://DoIhavePrediabetes.org  pic.twitter.com/AlpeK11qZv (Source: Food and Drug Adminstration (FDA): CDRHNew)
Source: Food and Drug Adminstration (FDA): CDRHNew - November 22, 2019 Category: Medical Devices Authors: ( at Surgeon_General) Source Type: news

“ Opioid use disorder is a chronic disease that can be treated, not a moral failing. ” -@Surgeon_General VADM Jerome M. Adams, MD, MPHpic.twitter.com/6AgzuTLmz1
“Opioid use disorder is a chronic disease that can be treated, not a moral failing.” - @Surgeon_General VADM Jerome M. Adams, MD, MPH pic.twitter.com/6AgzuTLmz1 (Source: Food and Drug Adminstration (FDA): CDRHNew)
Source: Food and Drug Adminstration (FDA): CDRHNew - November 21, 2019 Category: Medical Devices Authors: ( at FDAHealthEquity) Source Type: news

The @CDCgov & FDA #AntibioticResistance (AR) Isolate Bank provides information on resistance to support innovation in diagnostics and drug development. https://go.usa.gov/xpjs2   #USAAW2019pic.twitter.com/tYe8Gw2Kli
The @CDCgov & FDA #AntibioticResistance (AR) Isolate Bank provides information on resistance to support innovation in diagnostics and drug development. https://go.usa.gov/xpjs2  #USAAW2019 pic.twitter.com/tYe8Gw2Kli (Source: Food and Drug Adminstration (FDA): CDRHNew)
Source: Food and Drug Adminstration (FDA): CDRHNew - November 21, 2019 Category: Medical Devices Authors: ( at US_FDA) Source Type: news

Tomorrow is the big day! Learn how underserved communities have been impacted by the opioid crisis by registering for @FDAHealthEquity ’ s public meeting on November 21 from 9-4 PM ET. You can attend via webcast by registering here: https://www.eventbrite.com/e/public-meeting-strategies-to-improve-health-equity-amidst-the-opioid-crisis-tickets-70822278341   … pic.twitter.com/j3fKEN7xH5
Tomorrow is the big day! Learn how underserved communities have been impacted by the opioid crisis by registering for @FDAHealthEquity’s public meeting on November 21 from 9-4 PM ET. You can attend via webcast by registering here: https://www.eventbrite.com/e/public-meeting-strategies-to-improve-health-equity-amidst-the-opioid-crisis-tickets-70822278341 … pic.twitter.com/j3fKEN7xH5 (Source: Food and Drug Adminstration (FDA): CDRHNew)
Source: Food and Drug Adminstration (FDA): CDRHNew - November 20, 2019 Category: Medical Devices Authors: ( at FDAHealthEquity) Source Type: news

Did you know that African Americans have the highest prevalence of Alzheimer ’ s disease and related dementias among people ages 65 and older? Learn what progress is being made in early Alzheimer ’ s research: https://go.usa.gov/xQvqG   pic.twitter.com/5TB5z1lJw2
Did you know that African Americans have the highest prevalence of Alzheimer’s disease and related dementias among people ages 65 and older? Learn what progress is being made in early Alzheimer’s research: https://go.usa.gov/xQvqG  pic.twitter.com/5TB5z1lJw2 (Source: Food and Drug Adminstration (FDA): CDRHNew)
Source: Food and Drug Adminstration (FDA): CDRHNew - November 19, 2019 Category: Medical Devices Authors: ( at FDAHealthEquity) Source Type: news

Health care providers supporting cardiac patients with Getinge's Maquet/Datascope Intra-Aortic Balloon Pumps during transport should take the recommended steps outlined by the FDA to minimize the risk of patient harm. Learn more https://go.usa.gov/xp9Bq  
Health care providers supporting cardiac patients with Getinge's Maquet/Datascope Intra-Aortic Balloon Pumps during transport should take the recommended steps outlined by the FDA to minimize the risk of patient harm. Learn more https://go.usa.gov/xp9Bq  (Source: Food and Drug Adminstration (FDA): CDRHNew)
Source: Food and Drug Adminstration (FDA): CDRHNew - November 19, 2019 Category: Medical Devices Authors: ( at FDADeviceInfo) Source Type: news

The FDA continues to receive reports about these devices shutting down while running on battery power, leading to pump stop and loss of hemodynamic support.
(Source: Food and Drug Adminstration (FDA): CDRHNew)
Source: Food and Drug Adminstration (FDA): CDRHNew - November 19, 2019 Category: Medical Devices Authors: ( at FDADeviceInfo) Source Type: news

Today, the @US_FDA is providing an update on our evaluation of device failure associated with Getinge's Maquet/Datascope intra-aortic balloon pump (IABP) devices.pic.twitter.com/6eDYSscIgx
Today, the @US_FDA is providing an update on our evaluation of device failure associated with Getinge's Maquet/Datascope intra-aortic balloon pump (IABP) devices. pic.twitter.com/6eDYSscIgx (Source: Food and Drug Adminstration (FDA): CDRHNew)
Source: Food and Drug Adminstration (FDA): CDRHNew - November 19, 2019 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 19, 2019 Category: Medical Devices Authors: ( at FDADeviceInfo) Source Type: news

Antibiotics kill bacteria. Antibiotics do not kill viruses. This Antibiotics Awareness Week take a few minutes to learn more about how antibiotics work: https://go.usa.gov/xpKsW   #USAAW19 #BeAntibioticsAwarepic.twitter.com/9e7bEQW2GG
Antibiotics kill bacteria. Antibiotics do not kill viruses. This Antibiotics Awareness Week take a few minutes to learn more about how antibiotics work: https://go.usa.gov/xpKsW  #USAAW19 #BeAntibioticsAware pic.twitter.com/9e7bEQW2GG (Source: Food and Drug Adminstration (FDA): CDRHNew)
Source: Food and Drug Adminstration (FDA): CDRHNew - November 18, 2019 Category: Medical Devices Authors: ( at US_FDA) Source Type: news

There is still time left to register for @FDAHealthEquity ’ s public meeting on health equity and the opioid crisis. The meeting will be held on November 21 from 9-4 PM ET. You can attend in person or online. Register here: https://www.eventbrite.com/e/public-meeting-strategies-to-improve-health-equity-amidst-the-opioid-crisis-tickets-70822278341   … pic.twitter.com/kMMUjZfAAR
There is still time left to register for @FDAHealthEquity’s public meeting on health equity and the opioid crisis. The meeting will be held on November 21 from 9-4 PM ET. You can attend in person or online. Register here: https://www.eventbrite.com/e/public-meeting-strategies-to-improve-health-equity-amidst-the-opioid-crisis-tickets-70822278341 … pic.twitter.com/kMMUjZfAAR (Source: Food and Drug Adminstration (FDA): CDRHNew)
Source: Food and Drug Adminstration (FDA): CDRHNew - November 15, 2019 Category: Medical Devices Authors: ( at FDAHealthEquity) Source Type: news

Today the FDA approved the first targeted therapy to treat patients with a painful complication of sickle cell disease called vaso-occlusive crisis https://go.usa.gov/xpKhr   pic.twitter.com/uSfKXE0haC
Today the FDA approved the first targeted therapy to treat patients with a painful complication of sickle cell disease called vaso-occlusive crisis https://go.usa.gov/xpKhr  pic.twitter.com/uSfKXE0haC (Source: Food and Drug Adminstration (FDA): CDRHNew)
Source: Food and Drug Adminstration (FDA): CDRHNew - November 15, 2019 Category: Medical Devices Authors: ( at FDAMedia) Source Type: news

If you were unable to participate in today ’ s CDRH webinar about the @US_FDA ’ s Changes to Existing Medical Software Policies Resulting from Section 3060 of the 21st Century Cures Act Final Guidance, the transcript and recording will be available on Nov 22nd http://go.usa.gov/xpBZc  
If you were unable to participate in today’s CDRH webinar about the @US_FDA’s Changes to Existing Medical Software Policies Resulting from Section 3060 of the 21st Century Cures Act Final Guidance, the transcript and recording will be available on Nov 22nd http://go.usa.gov/xpBZc  (Source: Food and Drug Adminstration (FDA): CDRHNew)
Source: Food and Drug Adminstration (FDA): CDRHNew - November 14, 2019 Category: Medical Devices Authors: ( at FDADeviceInfo) Source Type: news

Want to know more about the @US_FDA's Changes to Existing Medical Software Policies Resulting from Section 3060 of the 21st Century Cures Act Final Guidance? Join us for today's webinar at 2 PM EST. https://go.usa.gov/xpBZc   pic.twitter.com/eukqf41j2d
Want to know more about the @US_FDA's Changes to Existing Medical Software Policies Resulting from Section 3060 of the 21st Century Cures Act Final Guidance? Join us for today's webinar at 2 PM EST. https://go.usa.gov/xpBZc  pic.twitter.com/eukqf41j2d (Source: Food and Drug Adminstration (FDA): CDRHNew)
Source: Food and Drug Adminstration (FDA): CDRHNew - November 14, 2019 Category: Medical Devices Authors: ( at FDADeviceInfo) Source Type: news

It ’ s #ChildSafetyMonth. Manicures and pedicures are a great way to treat yourself; however, be careful of your children opening nail polish – they may contain ingredients that are harmful. For #nailcare safety tips, visit: https://go.usa.gov/xprqD   pic.twitter.com/uwF7AOfQSo
It’s #ChildSafetyMonth. Manicures and pedicures are a great way to treat yourself; however, be careful of your children opening nail polish – they may contain ingredients that are harmful. For #nailcare safety tips, visit: https://go.usa.gov/xprqD  pic.twitter.com/uwF7AOfQSo (Source: Food and Drug Adminstration (FDA): CDRHNew)
Source: Food and Drug Adminstration (FDA): CDRHNew - November 14, 2019 Category: Medical Devices Authors: ( at FDACosmetics) Source Type: news

REMINDER: On November 14th from 2-3:30 PM EST, CDRH will host a webinar for industry and others interested in learning more about the Changes to Existing Medical Software Policies Resulting from Section 3060 of the 21st Century Cures Act Final Guidance. https://go.usa.gov/xpBZc   pic.twitter.com/AXKT5gWD2E
REMINDER: On November 14th from 2-3:30 PM EST, CDRH will host a webinar for industry and others interested in learning more about the Changes to Existing Medical Software Policies Resulting from Section 3060 of the 21st Century Cures Act Final Guidance. https://go.usa.gov/xpBZc  pic.twitter.com/AXKT5gWD2E (Source: Food and Drug Adminstration (FDA): CDRHNew)
Source: Food and Drug Adminstration (FDA): CDRHNew - November 13, 2019 Category: Medical Devices Authors: ( at FDADeviceInfo) Source Type: news

It is estimated that over 10 million Americans are affected by temporomandibular joint disorder (TMD).pic.twitter.com/xj3lPBOph0
It is estimated that over 10 million Americans are affected by temporomandibular joint disorder (TMD). pic.twitter.com/xj3lPBOph0 (Source: Food and Drug Adminstration (FDA): CDRHNew)
Source: Food and Drug Adminstration (FDA): CDRHNew - November 13, 2019 Category: Medical Devices Authors: ( at FDADeviceInfo) Source Type: news

Today, the @US_FDA launched new web pages with updated information on devices used to treat TMD, including temporomandibular joint (TMJ) implants. Find out more #MedicalDevice https://go.usa.gov/xpB3y  
Today, the @US_FDA launched new web pages with updated information on devices used to treat TMD, including temporomandibular joint (TMJ) implants. Find out more #MedicalDevice https://go.usa.gov/xpB3y  (Source: Food and Drug Adminstration (FDA): CDRHNew)
Source: Food and Drug Adminstration (FDA): CDRHNew - November 13, 2019 Category: Medical Devices Authors: ( at FDADeviceInfo) Source Type: news

The guidance explains why the FDA may deny issuing a Certificate to Foreign Government to medical device manufacturers, and what steps manufacturers can take to request a review of the denial. Find out more about the guidance. https://go.usa.gov/xpZH4  
The guidance explains why the FDA may deny issuing a Certificate to Foreign Government to medical device manufacturers, and what steps manufacturers can take to request a review of the denial. Find out more about the guidance. https://go.usa.gov/xpZH4  (Source: Food and Drug Adminstration (FDA): CDRHNew)
Source: Food and Drug Adminstration (FDA): CDRHNew - November 13, 2019 Category: Medical Devices Authors: ( at FDADeviceInfo) Source Type: news

Today, the @US_FDA issued the final guidance: Process to Request a Review of FDA's Decision Not to Issue Certain Export Certificates for Devices.pic.twitter.com/4ZzaKMbTvA
Today, the @US_FDA issued the final guidance: Process to Request a Review of FDA's Decision Not to Issue Certain Export Certificates for Devices. pic.twitter.com/4ZzaKMbTvA (Source: Food and Drug Adminstration (FDA): CDRHNew)
Source: Food and Drug Adminstration (FDA): CDRHNew - November 13, 2019 Category: Medical Devices Authors: ( at FDADeviceInfo) Source Type: news

The public meeting will be held in Gaithersburg, MD and available via webcast. Find out more about the meeting: https://go.usa.gov/xpZgr  
The public meeting will be held in Gaithersburg, MD and available via webcast. Find out more about the meeting: https://go.usa.gov/xpZgr  (Source: Food and Drug Adminstration (FDA): CDRHNew)
Source: Food and Drug Adminstration (FDA): CDRHNew - November 12, 2019 Category: Medical Devices Authors: ( at FDADeviceInfo) Source Type: news

REMINDER: On November 13-14, the @US_FDA will host a public meeting of the Immunology Devices Panel of the Medical Devices Advisory Committee to discuss metal-containing implants and dental amalgam.pic.twitter.com/67znit1FVn
REMINDER: On November 13-14, the @US_FDA will host a public meeting of the Immunology Devices Panel of the Medical Devices Advisory Committee to discuss metal-containing implants and dental amalgam. pic.twitter.com/67znit1FVn (Source: Food and Drug Adminstration (FDA): CDRHNew)
Source: Food and Drug Adminstration (FDA): CDRHNew - November 12, 2019 Category: Medical Devices Authors: ( at FDADeviceInfo) Source Type: news

Health care providers should closely monitor patients implanted with the STAR ankle replacement for possible follow-up and follow the recommendations provided in Stryker ’ s communication. Questions about this issue can be directed to Stryker ’ s call center at 1-888-644-2548
Health care providers should closely monitor patients implanted with the STAR ankle replacement for possible follow-up and follow the recommendations provided in Stryker’s communication. Questions about this issue can be directed to Stryker’s call center at 1-888-644-2548 (Source: Food and Drug Adminstration (FDA): CDRHNew)
Source: Food and Drug Adminstration (FDA): CDRHNew - November 12, 2019 Category: Medical Devices Authors: ( at FDADeviceInfo) Source Type: news

Patients with a STAR ankle replacement should be aware of the symptoms listed in Stryker Corp ’ s communication, since a polyethylene fracture may be subtle and go unnoticed, and contact their health care provider about potential next steps.pic.twitter.com/xIoaheNgax
Patients with a STAR ankle replacement should be aware of the symptoms listed in Stryker Corp’s communication, since a polyethylene fracture may be subtle and go unnoticed, and contact their health care provider about potential next steps. pic.twitter.com/xIoaheNgax (Source: Food and Drug Adminstration (FDA): CDRHNew)
Source: Food and Drug Adminstration (FDA): CDRHNew - November 12, 2019 Category: Medical Devices Authors: ( at FDADeviceInfo) Source Type: news

Stryker Corp, at @US_FDA's request, communicated about a higher than expected fracture rate of the polyethylene component in certain STAR Ankle Total Replacement devices distributed before August 2014, and made recommendations for patients and providers. https://www.stryker.com/content/dam/stryker/foot-and-ankle/products/star/resources/STAR%20Non-Foil%20UHMWPE%20Safety%20Communication%20-%2011OCT2019.pdf   …
Stryker Corp, at @US_FDA's request, communicated about a higher than expected fracture rate of the polyethylene component in certain STAR Ankle Total Replacement devices distributed before August 2014, and made recommendations for patients and providers. https://www.stryker.com/content/dam/stryker/foot-and-ankle/products/star/resources/STAR%20Non-Foil%20UHMWPE%20Safety%20Communication%20-%2011OCT2019.pdf … (Source: Food and Drug Adminstration (FDA): CDRHNew)
Source: Food and Drug Adminstration (FDA): CDRHNew - November 12, 2019 Category: Medical Devices Authors: ( at FDADeviceInfo) Source Type: news

DYK #cosmetics can get contaminated with microorganisms by dipping your fingers into the products or forgetting to completely close the packaging. #NationalHealthySkinMonth https://go.usa.gov/xprq4   pic.twitter.com/RM9T1BrpDC
DYK #cosmetics can get contaminated with microorganisms by dipping your fingers into the products or forgetting to completely close the packaging. #NationalHealthySkinMonth https://go.usa.gov/xprq4  pic.twitter.com/RM9T1BrpDC (Source: Food and Drug Adminstration (FDA): CDRHNew)
Source: Food and Drug Adminstration (FDA): CDRHNew - November 12, 2019 Category: Medical Devices Authors: ( at FDACosmetics) Source Type: news

Today, the @US_FDA identified a Class I Recall, the most serious type of recall: Zimmer Biomet Recalls ROSA Brain 3.0 Robotic Surgery System Due to Software Issue that Incorrectly Positions the Robotic Arm. Find out more about the recall: https://go.usa.gov/xpjBr   #MedicalDevicepic.twitter.com/ZAVfINitvY
Today, the @US_FDA identified a Class I Recall, the most serious type of recall: Zimmer Biomet Recalls ROSA Brain 3.0 Robotic Surgery System Due to Software Issue that Incorrectly Positions the Robotic Arm. Find out more about the recall: https://go.usa.gov/xpjBr  #MedicalDevice pic.twitter.com/ZAVfINitvY (Source: Food and Drug Adminstration (FDA): CDRHNew)
Source: Food and Drug Adminstration (FDA): CDRHNew - November 7, 2019 Category: Medical Devices Authors: ( at FDADeviceInfo) Source Type: news

If you were unable to participate in today ’ s CDRH webinar about the @US_FDA ’ s Safety and Performance Based Pathway Performance Criteria, the transcript and recording for today's webinar will be available on November 15th. http://go.usa.gov/xpbUb  
If you were unable to participate in today’s CDRH webinar about the @US_FDA’s Safety and Performance Based Pathway Performance Criteria, the transcript and recording for today's webinar will be available on November 15th. http://go.usa.gov/xpbUb  (Source: Food and Drug Adminstration (FDA): CDRHNew)
Source: Food and Drug Adminstration (FDA): CDRHNew - November 7, 2019 Category: Medical Devices Authors: ( at FDADeviceInfo) Source Type: news