When developing your indications for use statement for your medical device for submission to @US_FDA, consider the needs of other stakeholders in the healthcare ecosystem, including payors. #MedTechCon https://go.usa.gov/xVp2Q  
When developing your indications for use statement for your medical device for submission to @US_FDA, consider the needs of other stakeholders in the healthcare ecosystem, including payors. #MedTechCon https://go.usa.gov/xVp2Q  (Source: Food and Drug Adminstration (FDA): CDRHNew)
Source: Food and Drug Adminstration (FDA): CDRHNew - September 23, 2019 Category: Medical Devices Authors: ( at FDADeviceInfo) Source Type: news

Today at #MedTechCon, the @US_FDA highlights the Payor Communication Task Force.pic.twitter.com/DvTblrr4Qt
Today at #MedTechCon, the @US_FDA highlights the Payor Communication Task Force. pic.twitter.com/DvTblrr4Qt (Source: Food and Drug Adminstration (FDA): CDRHNew)
Source: Food and Drug Adminstration (FDA): CDRHNew - September 23, 2019 Category: Medical Devices Authors: ( at FDADeviceInfo) Source Type: news

Talk to a payor before starting your device clinical trial – Find out how @US_FDA can help: https://go.usa.gov/xVp2Q   #MedTechCon
Talk to a payor before starting your device clinical trial – Find out how @US_FDA can help: https://go.usa.gov/xVp2Q  #MedTechCon (Source: Food and Drug Adminstration (FDA): CDRHNew)
Source: Food and Drug Adminstration (FDA): CDRHNew - September 23, 2019 Category: Medical Devices Authors: ( at FDADeviceInfo) Source Type: news

In an effort to continue this level of engagement, @US_FDA has issued the draft guidance: Patient Engagement in Design & Conduct of Medical Device Clinical Investigations. Find out more about our commitment to patient engagement activities in clinical trials https://go.usa.gov/xVp4c  
In an effort to continue this level of engagement, @US_FDA has issued the draft guidance: Patient Engagement in Design&Conduct of Medical Device Clinical Investigations. Find out more about our commitment to patient engagement activities in clinical trials https://go.usa.gov/xVp4c  (Source: Food and Drug Adminstration (FDA): CDRHNew)
Source: Food and Drug Adminstration (FDA): CDRHNew - September 23, 2019 Category: Medical Devices Authors: ( at FDADeviceInfo) Source Type: news

Engaging patients, their families and caregivers, throughout the medical device clinical investigation process, creates more patient-centric clinical investigations and ultimately timely access to innovative, safe and effective medical devices.pic.twitter.com/oXwD16Smhp
Engaging patients, their families and caregivers, throughout the medical device clinical investigation process, creates more patient-centric clinical investigations and ultimately timely access to innovative, safe and effective medical devices. pic.twitter.com/oXwD16Smhp (Source: Food and Drug Adminstration (FDA): CDRHNew)
Source: Food and Drug Adminstration (FDA): CDRHNew - September 23, 2019 Category: Medical Devices Authors: ( at FDADeviceInfo) Source Type: news

Today, the @US_FDA published a draft guidance outlining the Accreditation Scheme for Conformity Assessment (#ASCA) Pilot, designed to simplify conformity assessment aspects of medical device premarket review. Find out more about the draft guidance: https://go.usa.gov/xVyG2   pic.twitter.com/Wyg4HyI30u
Today, the @US_FDA published a draft guidance outlining the Accreditation Scheme for Conformity Assessment ( #ASCA) Pilot, designed to simplify conformity assessment aspects of medical device premarket review. Find out more about the draft guidance: https://go.usa.gov/xVyG2  pic.twitter.com/Wyg4HyI30u (Source: Food and Drug Adminstration (FDA): CDRHNew)
Source: Food and Drug Adminstration (FDA): CDRHNew - September 20, 2019 Category: Medical Devices Authors: ( at FDADeviceInfo) Source Type: news

Part of our work assuring patients and health care professionals have timely and continued access to safe, effective and high-quality medical devices involves collaboration with diverse stakeholders. https://go.usa.gov/xVyxC   pic.twitter.com/oLx2bKTA51
Part of our work assuring patients and health care professionals have timely and continued access to safe, effective and high-quality medical devices involves collaboration with diverse stakeholders. https://go.usa.gov/xVyxC  pic.twitter.com/oLx2bKTA51 (Source: Food and Drug Adminstration (FDA): CDRHNew)
Source: Food and Drug Adminstration (FDA): CDRHNew - September 19, 2019 Category: Medical Devices Authors: ( at FDAMedia) Source Type: news

.@US_FDA also released the final Collaborative Communities Toolkit. https://go.usa.gov/xVy39  
. @US_FDA also released the final Collaborative Communities Toolkit. https://go.usa.gov/xVy39  (Source: Food and Drug Adminstration (FDA): CDRHNew)
Source: Food and Drug Adminstration (FDA): CDRHNew - September 19, 2019 Category: Medical Devices Authors: ( at FDADeviceInfo) Source Type: news

.@US_FDA announced its participation in two new collaborative communities, the Ophthalmic Imaging Collaborative Community and the National Evaluation System for Health Technology Coordinating Center (NESTcc) Collaborative Community (@NESTccMedTech).pic.twitter.com/Ljk74zs8Sa
. @US_FDA announced its participation in two new collaborative communities, the Ophthalmic Imaging Collaborative Community and the National Evaluation System for Health Technology Coordinating Center (NESTcc) Collaborative Community ( @NESTccMedTech). pic.twitter.com/Ljk74zs8Sa (Source: Food and Drug Adminstration (FDA): CDRHNew)
Source: Food and Drug Adminstration (FDA): CDRHNew - September 19, 2019 Category: Medical Devices Authors: ( at FDADeviceInfo) Source Type: news

For more information, please visit the “ Framework for the Safety and Performance Based Pathway ” page: https://go.usa.gov/xVmts   #MedicalDevice
For more information, please visit the “Framework for the Safety and Performance Based Pathway” page: https://go.usa.gov/xVmts  #MedicalDevice (Source: Food and Drug Adminstration (FDA): CDRHNew)
Source: Food and Drug Adminstration (FDA): CDRHNew - September 19, 2019 Category: Medical Devices Authors: ( at FDADeviceInfo) Source Type: news

Today, the @US_FDA issued four draft guidances and updated a final guidance related to the Safety and Performance Based Pathway as part of our commitment to strengthening and modernizing the 510(k) program, as described in the FDA ’ s Medical Device Safety Action Plan.pic.twitter.com/xdo85kmvrZ
Today, the @US_FDA issued four draft guidances and updated a final guidance related to the Safety and Performance Based Pathway as part of our commitment to strengthening and modernizing the 510(k) program, as described in the FDA’s Medical Device Safety Action Plan. pic.twitter.com/xdo85kmvrZ (Source: Food and Drug Adminstration (FDA): CDRHNew)
Source: Food and Drug Adminstration (FDA): CDRHNew - September 19, 2019 Category: Medical Devices Authors: ( at FDADeviceInfo) Source Type: news

If you were unable to participate in today ’ s CDRH webinar where we reviewed and answered questions about the De Novo Classification Requests Final Guidance, the transcript and recording will be available on September 26th. https://go.usa.gov/xVEBJ  
If you were unable to participate in today’s CDRH webinar where we reviewed and answered questions about the De Novo Classification Requests Final Guidance, the transcript and recording will be available on September 26th. https://go.usa.gov/xVEBJ  (Source: Food and Drug Adminstration (FDA): CDRHNew)
Source: Food and Drug Adminstration (FDA): CDRHNew - September 18, 2019 Category: Medical Devices Authors: ( at FDADeviceInfo) Source Type: news

(...cont) for the Breakthrough Devices Program, but the use of which may be associated with serious or life-threatening risks.
(Source: Food and Drug Adminstration (FDA): CDRHNew)
Source: Food and Drug Adminstration (FDA): CDRHNew - September 18, 2019 Category: Medical Devices Authors: ( at FDADeviceInfo) Source Type: news

Once finalized, the program will be a voluntary pathway for certain medical devices that is expected to significantly improve the safety of currently available treatments or diagnostic devices for diseases or conditions that are less serious than those eligible...(cont...)pic.twitter.com/oVusuVNhI4
Once finalized, the program will be a voluntary pathway for certain medical devices that is expected to significantly improve the safety of currently available treatments or diagnostic devices for diseases or conditions that are less serious than those eligible...(cont...) pic.twitter.com/oVusuVNhI4 (Source: Food and Drug Adminstration (FDA): CDRHNew)
Source: Food and Drug Adminstration (FDA): CDRHNew - September 18, 2019 Category: Medical Devices Authors: ( at FDADeviceInfo) Source Type: news

Today the @ US_FDA issued draft guidance outlining the vision for the Safer Technologies Program for Medical Devices. Find out more about the draft guidance: https://go.usa.gov/xVESA  
Today the @ US_FDA issued draft guidance outlining the vision for the Safer Technologies Program for Medical Devices. Find out more about the draft guidance: https://go.usa.gov/xVESA  (Source: Food and Drug Adminstration (FDA): CDRHNew)
Source: Food and Drug Adminstration (FDA): CDRHNew - September 18, 2019 Category: Medical Devices Authors: ( at FDADeviceInfo) Source Type: news

Want to know more about the @US_FDA ’ s current thinking about De Novo Classification Requests? Join us for a webinar on the FDA ’ s De Novo Classification Requests Final Guidance @11 am EDT https://go.usa.gov/xVEBJ   pic.twitter.com/apGgen7lft
Want to know more about the @US_FDA’s current thinking about De Novo Classification Requests? Join us for a webinar on the FDA’s De Novo Classification Requests Final Guidance @11 am EDT https://go.usa.gov/xVEBJ  pic.twitter.com/apGgen7lft (Source: Food and Drug Adminstration (FDA): CDRHNew)
Source: Food and Drug Adminstration (FDA): CDRHNew - September 18, 2019 Category: Medical Devices Authors: ( at FDADeviceInfo) Source Type: news

Aetna, a CVS company, has joined FDA's Payor Communication Task Force. Consider requesting a payor join your CDRH pre-submission meeting when you ’ re planning your pivotal clinical trial, which may shorten the time between FDA approval or clearance and coverage decisions.
Aetna, a CVS company, has joined FDA's Payor Communication Task Force. Consider requesting a payor join your CDRH pre-submission meeting when you’re planning your pivotal clinical trial, which may shorten the time between FDA approval or clearance and coverage decisions. (Source: Food and Drug Adminstration (FDA): CDRHNew)
Source: Food and Drug Adminstration (FDA): CDRHNew - September 17, 2019 Category: Medical Devices Authors: ( at FDADeviceInfo) Source Type: news

Learn more about the program https://go.usa.gov/xVEkw  
Learn more about the program https://go.usa.gov/xVEkw  (Source: Food and Drug Adminstration (FDA): CDRHNew)
Source: Food and Drug Adminstration (FDA): CDRHNew - September 17, 2019 Category: Medical Devices Authors: ( at FDADeviceInfo) Source Type: news

The @US_FDA hopes that these challenges will result in new sterilization methods or reduce emissions from ethylene oxide sterilization. #FDAInnovationChallenge
(Source: Food and Drug Adminstration (FDA): CDRHNew)
Source: Food and Drug Adminstration (FDA): CDRHNew - September 17, 2019 Category: Medical Devices Authors: ( at FDADeviceInfo) Source Type: news

The @US_FDA will accept submissions through Oct. 15, 2019, and intends to announce the selected applicants in December 2019. #FDAInnovationChallenge
(Source: Food and Drug Adminstration (FDA): CDRHNew)
Source: Food and Drug Adminstration (FDA): CDRHNew - September 17, 2019 Category: Medical Devices Authors: ( at FDADeviceInfo) Source Type: news

#ICYMI As part of the @US_FDA ’ s ongoing effort to address the safety & use of ethylene oxide when used to sterilize medical devices, the agency has announced two innovation challenges to encourage new approaches to medical device sterilization. http://go.usa.gov/xyPJR  
#ICYMI As part of the @US_FDA’s ongoing effort to address the safety & use of ethylene oxide when used to sterilize medical devices, the agency has announced two innovation challenges to encourage new approaches to medical device sterilization. http://go.usa.gov/xyPJR  (Source: Food and Drug Adminstration (FDA): CDRHNew)
Source: Food and Drug Adminstration (FDA): CDRHNew - September 17, 2019 Category: Medical Devices Authors: ( at FDADeviceInfo) Source Type: news

REMINDER: On Wednesday September 18th, the @US_FDA will host a webinar on the Final Guidance for the Acceptance Review for De Novo Classification Requests:. Find out more about tomorrow's webinar: https://go.usa.gov/xVPQF   #FDA #MedicalDevice.pic.twitter.com/miussoOv30
REMINDER: On Wednesday September 18th, the @US_FDA will host a webinar on the Final Guidance for the Acceptance Review for De Novo Classification Requests:. Find out more about tomorrow's webinar: https://go.usa.gov/xVPQF  #FDA #MedicalDevice. pic.twitter.com/miussoOv30 (Source: Food and Drug Adminstration (FDA): CDRHNew)
Source: Food and Drug Adminstration (FDA): CDRHNew - September 17, 2019 Category: Medical Devices Authors: ( at FDADeviceInfo) Source Type: news

National Preparedness Month is a great time to get kids involved in preparing for emergencies. Involve the whole family in preparing an emergency plan for your furry family members. https://go.usa.gov/xVgWF   #NatlPrep #ReadyKidspic.twitter.com/oTwqs1g1ei
National Preparedness Month is a great time to get kids involved in preparing for emergencies. Involve the whole family in preparing an emergency plan for your furry family members. https://go.usa.gov/xVgWF  #NatlPrep #ReadyKids pic.twitter.com/oTwqs1g1ei (Source: Food and Drug Adminstration (FDA): CDRHNew)
Source: Food and Drug Adminstration (FDA): CDRHNew - September 16, 2019 Category: Medical Devices Authors: ( at US_FDA) Source Type: news

Update #1 “ Format for Traditional and Abbreviated (510(k)s) ” Final Guidance: https://go.usa.gov/xVnGZ  
Update #1 “Format for Traditional and Abbreviated (510(k)s)” Final Guidance: https://go.usa.gov/xVnGZ  (Source: Food and Drug Adminstration (FDA): CDRHNew)
Source: Food and Drug Adminstration (FDA): CDRHNew - September 12, 2019 Category: Medical Devices Authors: ( at FDADeviceInfo) Source Type: news

Update #2: “ Refuse to Accept Policy for 510(k)s ” Final Guidance: https://go.usa.gov/xVnGB  
Update #2: “Refuse to Accept Policy for 510(k)s” Final Guidance: https://go.usa.gov/xVnGB  (Source: Food and Drug Adminstration (FDA): CDRHNew)
Source: Food and Drug Adminstration (FDA): CDRHNew - September 12, 2019 Category: Medical Devices Authors: ( at FDADeviceInfo) Source Type: news

The @US_FDA also issued a final guidance on The Abbreviated 510(k) Program. Together, these guidance documents will superseded “ The New 510(k) Paradigm: Alternate Approaches to Demonstrating Substantial Equivalence in Premarket Notifications ” guidance: https://go.usa.gov/xVnGT   pic.twitter.com/NbRqWru8kB
The @US_FDA also issued a final guidance on The Abbreviated 510(k) Program. Together, these guidance documents will superseded “The New 510(k) Paradigm: Alternate Approaches to Demonstrating Substantial Equivalence in Premarket Notifications” guidance: https://go.usa.gov/xVnGT  pic.twitter.com/NbRqWru8kB (Source: Food and Drug Adminstration (FDA): CDRHNew)
Source: Food and Drug Adminstration (FDA): CDRHNew - September 12, 2019 Category: Medical Devices Authors: ( at FDADeviceInfo) Source Type: news

In an effort to improve alignment between the related 510(k) guidance, and reflect current policies, the @US_FDA also updated two related guidance documents:
(Source: Food and Drug Adminstration (FDA): CDRHNew)
Source: Food and Drug Adminstration (FDA): CDRHNew - September 12, 2019 Category: Medical Devices Authors: ( at FDADeviceInfo) Source Type: news

Learn more about the Special 510(k) Program guidance: https://go.usa.gov/xVnGq  
Learn more about the Special 510(k) Program guidance: https://go.usa.gov/xVnGq  (Source: Food and Drug Adminstration (FDA): CDRHNew)
Source: Food and Drug Adminstration (FDA): CDRHNew - September 12, 2019 Category: Medical Devices Authors: ( at FDADeviceInfo) Source Type: news

Today, the @ US_FDA issued final guidance on The Special 510(k) Program. The program is an optional regulatory pathway that simplifies the review of certain 510(k)s for industry and FDA staff using efficient practices consistent with least burdensome principles.pic.twitter.com/eryJzqVssl
Today, the @ US_FDA issued final guidance on The Special 510(k) Program. The program is an optional regulatory pathway that simplifies the review of certain 510(k)s for industry and FDA staff using efficient practices consistent with least burdensome principles. pic.twitter.com/eryJzqVssl (Source: Food and Drug Adminstration (FDA): CDRHNew)
Source: Food and Drug Adminstration (FDA): CDRHNew - September 12, 2019 Category: Medical Devices Authors: ( at FDADeviceInfo) Source Type: news

#DYK: The Office of Science and Engineering Laboratories here at @US_FDA promotes the innovation of newer, safer and more effective medical devices? Check out what's been happening here at OSEL: https://youtube.com/watch?v=m-73PWZjIXI   … #FDA #MedicalDevice
#DYK: The Office of Science and Engineering Laboratories here at @US_FDA promotes the innovation of newer, safer and more effective medical devices? Check out what's been happening here at OSEL: https://youtube.com/watch?v=m-73PWZjIXI … #FDA #MedicalDevice (Source: Food and Drug Adminstration (FDA): CDRHNew)
Source: Food and Drug Adminstration (FDA): CDRHNew - September 12, 2019 Category: Medical Devices Authors: ( at FDADeviceInfo) Source Type: news

FDA reminds the public that no youth should be using any vaping product, regardless of the substance being inhaled. As kids head #BacktoSchool – a place where they vape or see their peers vape – “ The Real Cost ” campaign strives to help prevent youth e-cigarette use. THREAD pic.twitter.com/GMl2RyMvaS
FDA reminds the public that no youth should be using any vaping product, regardless of the substance being inhaled. As kids head #BacktoSchool – a place where they vape or see their peers vape – “The Real Cost” campaign strives to help prevent youth e-cigarette use. THREAD pic.twitter.com/GMl2RyMvaS (Source: Food and Drug Adminstration (FDA): CDRHNew)
Source: Food and Drug Adminstration (FDA): CDRHNew - September 12, 2019 Category: Medical Devices Authors: ( at FDATobacco) Source Type: news

Manufacturers should be responsible for educating not only the providers, but the patients receiving their device. Discussion at #PEAC2019
Discussion at #PEAC2019 (Source: Food and Drug Adminstration (FDA): CDRHNew)
Source: Food and Drug Adminstration (FDA): CDRHNew - September 11, 2019 Category: Medical Devices Authors: ( at FDADeviceInfo) Source Type: news

Thank you to everyone who participated in today ’ s #PEAC2019 meeting. Everyone provided thoughtful discussion and recommendations for the @US_FDA to consider when communicating cybersecurity risks. A summary of the meeting will be available at https://go.usa.gov/xVNvv  
Thank you to everyone who participated in today’s #PEAC2019 meeting. Everyone provided thoughtful discussion and recommendations for the @US_FDA to consider when communicating cybersecurity risks. A summary of the meeting will be available at https://go.usa.gov/xVNvv  (Source: Food and Drug Adminstration (FDA): CDRHNew)
Source: Food and Drug Adminstration (FDA): CDRHNew - September 11, 2019 Category: Medical Devices Authors: ( at FDADeviceInfo) Source Type: news

How much information you can provide is very individual to the type of device a person has & how it impacts them. There is no substitute for talking to patients w/in a community of patients w/ a specific disease/device, as they are experts in this area. Discussion at #PEAC2019
Discussion at #PEAC2019 (Source: Food and Drug Adminstration (FDA): CDRHNew)
Source: Food and Drug Adminstration (FDA): CDRHNew - September 11, 2019 Category: Medical Devices Authors: ( at FDADeviceInfo) Source Type: news

It is critical when communicating cybersecurity information to hear from the patient community about what information they want and how they want to receive it. Advisory Committee Discussion at #PEAC2019
Discussion at #PEAC2019 (Source: Food and Drug Adminstration (FDA): CDRHNew)
Source: Food and Drug Adminstration (FDA): CDRHNew - September 11, 2019 Category: Medical Devices Authors: ( at FDADeviceInfo) Source Type: news

Medical device technicians should have training on cybersecurity. Physicians should focus on care and defer the technical expertise. Committee discussion on FDA questions about communicating cybersecurity today at #PEAC2019
Medical device technicians should have training on cybersecurity. Physicians should focus on care and defer the technical expertise. Committee discussion on FDA questions about communicating cybersecurity today at #PEAC2019 (Source: Food and Drug Adminstration (FDA): CDRHNew)
Source: Food and Drug Adminstration (FDA): CDRHNew - September 11, 2019 Category: Medical Devices Authors: ( at FDADeviceInfo) Source Type: news

" ...I would want to know 1. What I need to do to mitigate the risks and 2. And what do I do if I feel I believe I have been impacted. ” Patient during public open hearing at #PEAC2019
"...I would want to know 1. What I need to do to mitigate the risks and 2. And what do I do if I feel I believe I have been impacted.” Patient during public open hearing at #PEAC2019 (Source: Food and Drug Adminstration (FDA): CDRHNew)
Source: Food and Drug Adminstration (FDA): CDRHNew - September 10, 2019 Category: Medical Devices Authors: ( at FDADeviceInfo) Source Type: news

“ I would prefer my first communication come through as a text message from my doctor ’ s office that tells me to call my doctor... "
“I would prefer my first communication come through as a text message from my doctor’s office that tells me to call my doctor..." (Source: Food and Drug Adminstration (FDA): CDRHNew)
Source: Food and Drug Adminstration (FDA): CDRHNew - September 10, 2019 Category: Medical Devices Authors: ( at FDADeviceInfo) Source Type: news

Patients like to get information from online communities of others who share their condition. @KarenMcChesney from @JDRF on where patients like to receive and discuss safety information. #PEAC2019pic.twitter.com/kOssgY2p1Q
Patients like to get information from online communities of others who share their condition. @KarenMcChesney from @JDRF on where patients like to receive and discuss safety information. #PEAC2019 pic.twitter.com/kOssgY2p1Q (Source: Food and Drug Adminstration (FDA): CDRHNew)
Source: Food and Drug Adminstration (FDA): CDRHNew - September 10, 2019 Category: Medical Devices Authors: ( at FDADeviceInfo) Source Type: news

.@CatinaOLeary from @HealthLitMedia says public perception of risk is often based more on the perceived magnitude of harm and less on the probability of that harm occurring. We must communicate the uncertainty. #PEAC2019 http://fda.yorkcast.com/webcast/Play/57a12d7dfedd403cade78222ceae86ef1d   …
. @CatinaOLeary from @HealthLitMedia says public perception of risk is often based more on the perceived magnitude of harm and less on the probability of that harm occurring. We must communicate the uncertainty. #PEAC2019 http://fda.yorkcast.com/webcast/Play/57a12d7dfedd403cade78222ceae86ef1d … (Source: Food and Drug Adminstration (FDA): CDRHNew)
Source: Food and Drug Adminstration (FDA): CDRHNew - September 10, 2019 Category: Medical Devices Authors: ( at FDADeviceInfo) Source Type: news

“ As a patient I want to know that companies are doing everything they can to make their devices as safe was they can ” Jay Radcliffe, @jradcliffe02 #PEAC2019
“As a patient I want to know that companies are doing everything they can to make their devices as safe was they can” Jay Radcliffe, @jradcliffe02 #PEAC2019 (Source: Food and Drug Adminstration (FDA): CDRHNew)
Source: Food and Drug Adminstration (FDA): CDRHNew - September 10, 2019 Category: Medical Devices Authors: ( at FDADeviceInfo) Source Type: news

“ We can do all this great work to communicate to patients, but if we don ’ t spend time educating physicans they won ’ t be able to communicate to their patients ” - @CDameffMD, Dr. Christian Dameff provides physician perspectives on cybersecurity at today ’ s #PEAC2019 meetingpic.twitter.com/DsjrLTDQlQ
“We can do all this great work to communicate to patients, but if we don’t spend time educating physicans they won’t be able to communicate to their patients” - @CDameffMD, Dr. Christian Dameff provides physician perspectives on cybersecurity at today’s #PEAC2019 meeting pic.twitter.com/DsjrLTDQlQ (Source: Food and Drug Adminstration (FDA): CDRHNew)
Source: Food and Drug Adminstration (FDA): CDRHNew - September 10, 2019 Category: Medical Devices Authors: ( at FDADeviceInfo) Source Type: news

.@FDACommissioner, Dr. Ned Sharpless opens today ’ s #PEAC2019 meeting, says today ’ s session will focus exclusively on patient perspective and how to communicate cybersecurity risks in medical devices. Follow along through the webcast: http://fda.yorkcast.com/webcast/Play/57a12d7dfedd403cade78222ceae86ef1d   …
. @FDACommissioner, Dr. Ned Sharpless opens today’s #PEAC2019 meeting, says today’s session will focus exclusively on patient perspective and how to communicate cybersecurity risks in medical devices. Follow along through the webcast: http://fda.yorkcast.com/webcast/Play/57a12d7dfedd403cade78222ceae86ef1d … (Source: Food and Drug Adminstration (FDA): CDRHNew)
Source: Food and Drug Adminstration (FDA): CDRHNew - September 10, 2019 Category: Medical Devices Authors: ( at FDADeviceInfo) Source Type: news

REMINDER: Join the @US_FDA tomorrow Tuesday, Sept 10, 2019 for a meeting of the Patient Engagement Advisory Committee. https://go.usa.gov/xV8Xf   #PEAC #cybersecuritypic.twitter.com/PlZLglFdeY
REMINDER: Join the @US_FDA tomorrow Tuesday, Sept 10, 2019 for a meeting of the Patient Engagement Advisory Committee. https://go.usa.gov/xV8Xf  #PEAC #cybersecurity pic.twitter.com/PlZLglFdeY (Source: Food and Drug Adminstration (FDA): CDRHNew)
Source: Food and Drug Adminstration (FDA): CDRHNew - September 9, 2019 Category: Medical Devices Authors: ( at FDADeviceInfo) Source Type: news

Always lay your baby down to sleep on their back - every time #BabySafetyMonth #MondayMoodpic.twitter.com/qxaLAsjmzC
Always lay your baby down to sleep on their back - every time #BabySafetyMonth #MondayMood pic.twitter.com/qxaLAsjmzC (Source: Food and Drug Adminstration (FDA): CDRHNew)
Source: Food and Drug Adminstration (FDA): CDRHNew - September 9, 2019 Category: Medical Devices Authors: ( at USCPSC) Source Type: news

September is also National Preparedness Month. Are you prepared for possible severe weather? Floods, fires & other natural disasters could jeopardize the safety of your food. Reduce the risk of foodborne illness with these tips: http://go.usa.gov/xUzMu   pic.twitter.com/jAQxO0KgnG
September is also National Preparedness Month. Are you prepared for possible severe weather? Floods, fires & other natural disasters could jeopardize the safety of your food. Reduce the risk of foodborne illness with these tips: http://go.usa.gov/xUzMu  pic.twitter.com/jAQxO0KgnG (Source: Food and Drug Adminstration (FDA): CDRHNew)
Source: Food and Drug Adminstration (FDA): CDRHNew - September 9, 2019 Category: Medical Devices Authors: ( at USDAFoodSafety) Source Type: news

Also, check out the @US_FDA's tips for using a generator to restore power to medical devices that may have been affected by power outages caused by heavy rain and flooding from #Dorian https://go.usa.gov/xPjau   https://twitter.com/Readygov/status/1170004579007782915   …
Also, check out the @US_FDA's tips for using a generator to restore power to medical devices that may have been affected by power outages caused by heavy rain and flooding from #Dorian https://go.usa.gov/xPjau  https://twitter.com/Readygov/status/1170004579007782915 … (Source: Food and Drug Adminstration (FDA): CDRHNew)
Source: Food and Drug Adminstration (FDA): CDRHNew - September 6, 2019 Category: Medical Devices Authors: ( at FDADeviceInfo) Source Type: news

Farmers/Food Producers: If you ’ re in areas hit by Hurricane #Dorian, we have materials which can be used when assessing potential damage to your food crops. We encourage growers to work with state regulators & local FDA offices to assess their situations https://go.usa.gov/xVD8n   pic.twitter.com/LxNIPOeZpr
Farmers/Food Producers: If you’re in areas hit by Hurricane #Dorian, we have materials which can be used when assessing potential damage to your food crops. We encourage growers to work with state regulators & local FDA offices to assess their situations https://go.usa.gov/xVD8n  pic.twitter.com/LxNIPOeZpr (Source: Food and Drug Adminstration (FDA): CDRHNew)
Source: Food and Drug Adminstration (FDA): CDRHNew - September 6, 2019 Category: Medical Devices Authors: ( at US_FDA) Source Type: news

The final guidance will provide industry with clarity on the information to submit in a De Novo request & enhance patient access to new, safe and effective medical devices. https://go.usa.gov/xV9Jk  
The final guidance will provide industry with clarity on the information to submit in a De Novo request & enhance patient access to new, safe and effective medical devices. https://go.usa.gov/xV9Jk  (Source: Food and Drug Adminstration (FDA): CDRHNew)
Source: Food and Drug Adminstration (FDA): CDRHNew - September 6, 2019 Category: Medical Devices Authors: ( at FDADeviceInfo) Source Type: news

Today, the @US_FDA issued final guidance on Acceptance Review for De Novo Classification Requests. #MedicalDevice #FDApic.twitter.com/HtkvI6NEfK
Today, the @US_FDA issued final guidance on Acceptance Review for De Novo Classification Requests. #MedicalDevice #FDA pic.twitter.com/HtkvI6NEfK (Source: Food and Drug Adminstration (FDA): CDRHNew)
Source: Food and Drug Adminstration (FDA): CDRHNew - September 6, 2019 Category: Medical Devices Authors: ( at FDADeviceInfo) Source Type: news