Today, FDA became the first medical products regulatory body in the world to approve an expanded indication for several transcatheter heart valves to patients at low risk for death or major complications associated with open-heart surgery: https://go.usa.gov/xVCnx   pic.twitter.com/i4Y0jh52Xh
Today, FDA became the first medical products regulatory body in the world to approve an expanded indication for several transcatheter heart valves to patients at low risk for death or major complications associated with open-heart surgery: https://go.usa.gov/xVCnx  pic.twitter.com/i4Y0jh52Xh (Source: Food and Drug Adminstration (FDA): CDRHNew)
Source: Food and Drug Adminstration (FDA): CDRHNew - August 16, 2019 Category: Medical Devices Authors: ( at FDAMedia) Source Type: news

On September 5th, hear from community innovators, industry and patients on current trends in regulatory science and innovative regulatory science tools. Registration for the 2019 @MDIConline in-person Annual Public Forum closes on August 16th https://apf.mdic.org/   pic.twitter.com/YDhOpsDNUs
On September 5th, hear from community innovators, industry and patients on current trends in regulatory science and innovative regulatory science tools. Registration for the 2019 @MDIConline in-person Annual Public Forum closes on August 16th https://apf.mdic.org/  pic.twitter.com/YDhOpsDNUs (Source: Food and Drug Adminstration (FDA): CDRHNew)
Source: Food and Drug Adminstration (FDA): CDRHNew - August 14, 2019 Category: Medical Devices Authors: ( at FDADeviceInfo) Source Type: news

REMINDER: Tomorrow, August 13, 2019 from 3-4:30 ET, the @US_FDA will host a webinar to provide developers and interested applicants an opportunity to hear from the FDA and answer questions about the Ethylene Oxide challenges: http://go.usa.gov/xyPJG   #FDAInnovationChallengepic.twitter.com/8gDOu9xq1n
REMINDER: Tomorrow, August 13, 2019 from 3-4:30 ET, the @US_FDA will host a webinar to provide developers and interested applicants an opportunity to hear from the FDA and answer questions about the Ethylene Oxide challenges: http://go.usa.gov/xyPJG  #FDAInnovationChallenge pic.twitter.com/8gDOu9xq1n (Source: Food and Drug Adminstration (FDA): CDRHNew)
Source: Food and Drug Adminstration (FDA): CDRHNew - August 12, 2019 Category: Medical Devices Authors: ( at FDADeviceInfo) Source Type: news

ONE WEEK LEFT to register for @MDIConline's Annual Public Forum. Register today! http://bit.ly/31WaMN1   pic.twitter.com/u5sSVei2UE
ONE WEEK LEFT to register for @MDIConline's Annual Public Forum. Register today! http://bit.ly/31WaMN1  pic.twitter.com/u5sSVei2UE (Source: Food and Drug Adminstration (FDA): CDRHNew)
Source: Food and Drug Adminstration (FDA): CDRHNew - August 10, 2019 Category: Medical Devices Authors: ( at MDICAnnualForum) Source Type: news

User Fees help the @US_FDA increase the efficiency of regulatory processes with a goal of reducing the time it takes to bring safe and effective medical devices to the U.S. market.
(Source: Food and Drug Adminstration (FDA): CDRHNew)
Source: Food and Drug Adminstration (FDA): CDRHNew - August 8, 2019 Category: Medical Devices Authors: ( at FDADeviceInfo) Source Type: news

On July 31, 2019, @US_FDA announced the FY2020 user fees in a Federal Register notice titled Medical Device User Fee Rates for Fiscal Year 2020. Find out more: https://go.usa.gov/xySJV  
On July 31, 2019, @US_FDA announced the FY2020 user fees in a Federal Register notice titled Medical Device User Fee Rates for Fiscal Year 2020. Find out more: https://go.usa.gov/xySJV  (Source: Food and Drug Adminstration (FDA): CDRHNew)
Source: Food and Drug Adminstration (FDA): CDRHNew - August 8, 2019 Category: Medical Devices Authors: ( at FDADeviceInfo) Source Type: news

On August 5th, the @US_FDA identified a Class I Recall, the most serious type of recall: Abbott recalls Ellipse Implantable Cardioverter Defibrillators due to exposed aluminum wires. Find out more about the recall: https://go.usa.gov/xySzm   #MedicalDevicepic.twitter.com/3Vsug4KRKB
On August 5th, the @US_FDA identified a Class I Recall, the most serious type of recall: Abbott recalls Ellipse Implantable Cardioverter Defibrillators due to exposed aluminum wires. Find out more about the recall: https://go.usa.gov/xySzm  #MedicalDevice pic.twitter.com/3Vsug4KRKB (Source: Food and Drug Adminstration (FDA): CDRHNew)
Source: Food and Drug Adminstration (FDA): CDRHNew - August 8, 2019 Category: Medical Devices Authors: ( at FDADeviceInfo) Source Type: news

#DYK #hurricane season is active through November. Be prepared & stay informed of #MedicalDevice safety. Check out the @US_FDA's useful planning booklet that can help you prepare & handle power outages for medical devices that use electricity: https://go.usa.gov/xPbYt  
#DYK #hurricane season is active through November. Be prepared & stay informed of #MedicalDevice safety. Check out the @US_FDA's useful planning booklet that can help you prepare & handle power outages for medical devices that use electricity: https://go.usa.gov/xPbYt  (Source: Food and Drug Adminstration (FDA): CDRHNew)
Source: Food and Drug Adminstration (FDA): CDRHNew - August 8, 2019 Category: Medical Devices Authors: ( at FDADeviceInfo) Source Type: news

NOAA's *Updated* 2019 Atlantic #HurricaneSeason Outlook now calls for: 10-17 named storms of which 5-9 could become hurricanes, including 2-4 major hurricanes. But remember: #ItOnlyTakesOne http://bit.ly/HurrSeasonUpdate2019   … pic.twitter.com/tZL9Hu0922
NOAA's *Updated* 2019 Atlantic #HurricaneSeason Outlook now calls for: 10-17 named storms of which 5-9 could become hurricanes, including 2-4 major hurricanes. But remember: #ItOnlyTakesOne http://bit.ly/HurrSeasonUpdate2019 … pic.twitter.com/tZL9Hu0922 (Source: Food and Drug Adminstration (FDA): CDRHNew)
Source: Food and Drug Adminstration (FDA): CDRHNew - August 8, 2019 Category: Medical Devices Authors: ( at NOAA) Source Type: news

#DYK August 6th was #NationalFreshBreathDay and the @US_FDA encourages routine brushing, flossing, and dental exams.pic.twitter.com/IOo4eWKMUM
#DYK August 6th was #NationalFreshBreathDay and the @US_FDA encourages routine brushing, flossing, and dental exams. pic.twitter.com/IOo4eWKMUM (Source: Food and Drug Adminstration (FDA): CDRHNew)
Source: Food and Drug Adminstration (FDA): CDRHNew - August 8, 2019 Category: Medical Devices Authors: ( at FDADeviceInfo) Source Type: news

Save the Date: On Wednesday, October 2nd from 1-2:30 PM EST, the @US_FDA will host a webinar on Dental Device Premarket Submissions. Find out more about the upcoming webinar: https://go.usa.gov/xyubH   #FDA #MedicalDevicepic.twitter.com/jiqGk25UmB
Save the Date: On Wednesday, October 2nd from 1-2:30 PM EST, the @US_FDA will host a webinar on Dental Device Premarket Submissions. Find out more about the upcoming webinar: https://go.usa.gov/xyubH  #FDA #MedicalDevice pic.twitter.com/jiqGk25UmB (Source: Food and Drug Adminstration (FDA): CDRHNew)
Source: Food and Drug Adminstration (FDA): CDRHNew - August 5, 2019 Category: Medical Devices Authors: ( at FDADeviceInfo) Source Type: news

#ICYMI https://twitter.com/US_FDA/status/1156665387527876608   …
#ICYMI https://twitter.com/US_FDA/status/1156665387527876608 … (Source: Food and Drug Adminstration (FDA): CDRHNew)
Source: Food and Drug Adminstration (FDA): CDRHNew - August 2, 2019 Category: Medical Devices Authors: ( at FDADeviceInfo) Source Type: news

#DYK https://twitter.com/FDACommissioner/status/1157262935783333889   …
#DYK https://twitter.com/FDACommissioner/status/1157262935783333889 … (Source: Food and Drug Adminstration (FDA): CDRHNew)
Source: Food and Drug Adminstration (FDA): CDRHNew - August 2, 2019 Category: Medical Devices Authors: ( at FDADeviceInfo) Source Type: news

MRIs are powerful tools for health care professionals to diagnose medical conditions & guide certain procedures. Today, FDA issued a new draft guidance to describe the testing needed for medical devices when they are used with MRI scanners https://go.usa.gov/xyest   pic.twitter.com/KgRoQ0JdWv
MRIs are powerful tools for health care professionals to diagnose medical conditions & guide certain procedures. Today, FDA issued a new draft guidance to describe the testing needed for medical devices when they are used with MRI scanners https://go.usa.gov/xyest  pic.twitter.com/KgRoQ0JdWv (Source: Food and Drug Adminstration (FDA): CDRHNew)
Source: Food and Drug Adminstration (FDA): CDRHNew - August 1, 2019 Category: Medical Devices Authors: ( at US_FDA) Source Type: news

Today, the @US_FDA issued a draft guidance for comments on recommendations on assessing the safety and compatibility of medical devices in the MR Environment and formatting for device labeling. Read more: http://go.usa.gov/xyewp   pic.twitter.com/tkTspJgixP
Today, the @US_FDA issued a draft guidance for comments on recommendations on assessing the safety and compatibility of medical devices in the MR Environment and formatting for device labeling. Read more: http://go.usa.gov/xyewp  pic.twitter.com/tkTspJgixP (Source: Food and Drug Adminstration (FDA): CDRHNew)
Source: Food and Drug Adminstration (FDA): CDRHNew - August 1, 2019 Category: Medical Devices Authors: ( at FDADeviceInfo) Source Type: news

Ensuring the safety of patients and health care professionals who use magnetic resonance imaging for disease diagnosis and health management is imperative. #MedicalDevice #FDA
(Source: Food and Drug Adminstration (FDA): CDRHNew)
Source: Food and Drug Adminstration (FDA): CDRHNew - August 1, 2019 Category: Medical Devices Authors: ( at FDADeviceInfo) Source Type: news

The recommendations provided by the committee will address factors to be considered by FDA & industry when communicating cybersecurity risks, including but not limited to the content, phrasing, the methods used to disseminate the message and the timing of that communication & ...
The recommendations provided by the committee will address factors to be considered by FDA & industry when communicating cybersecurity risks, including but not limited to the content, phrasing, the methods used to disseminate the message and the timing of that communication &... (Source: Food and Drug Adminstration (FDA): CDRHNew)
Source: Food and Drug Adminstration (FDA): CDRHNew - August 1, 2019 Category: Medical Devices Authors: ( at FDADeviceInfo) Source Type: news

Concerns patients have about changes (such as security patches and updates) to their devices to reduce cybersecurity risks as well as the role of other stakeholders such as health care providers in communicating cybersecurity risks to patients. #PEAC #MedicalDevice #FDA
(Source: Food and Drug Adminstration (FDA): CDRHNew)
Source: Food and Drug Adminstration (FDA): CDRHNew - August 1, 2019 Category: Medical Devices Authors: ( at FDADeviceInfo) Source Type: news

#ICYMI Save the Date and join @US_FDA on Sept 10 for a meeting of the Patient Engagement Advisory Committee. The committee will discuss and make recommendations on communicating cybersecurity risks to patients, health care providers and other stakeholders. https://go.usa.gov/xyeVc  
#ICYMI Save the Date and join @US_FDA on Sept 10 for a meeting of the Patient Engagement Advisory Committee. The committee will discuss and make recommendations on communicating cybersecurity risks to patients, health care providers and other stakeholders. https://go.usa.gov/xyeVc  (Source: Food and Drug Adminstration (FDA): CDRHNew)
Source: Food and Drug Adminstration (FDA): CDRHNew - August 1, 2019 Category: Medical Devices Authors: ( at FDADeviceInfo) Source Type: news

Today, the FDA issued new resources to aid third parties that participate or would like to participate in the 510(k) Third Party Review Program. Learn more about the updates: https://go.usa.gov/xyMfP   #MedicalDevice
Today, the FDA issued new resources to aid third parties that participate or would like to participate in the 510(k) Third Party Review Program. Learn more about the updates: https://go.usa.gov/xyMfP  #MedicalDevice (Source: Food and Drug Adminstration (FDA): CDRHNew)
Source: Food and Drug Adminstration (FDA): CDRHNew - July 31, 2019 Category: Medical Devices Authors: ( at FDADeviceInfo) Source Type: news

The @US_FDA ’ s Third Party Review program provides manufacturers an alternative process for review of certain low-to-moderate risk medical devices by accredited third party review organizations.
The @US_FDA’s Third Party Review program provides manufacturers an alternative process for review of certain low-to-moderate risk medical devices by accredited third party review organizations. (Source: Food and Drug Adminstration (FDA): CDRHNew)
Source: Food and Drug Adminstration (FDA): CDRHNew - July 31, 2019 Category: Medical Devices Authors: ( at FDADeviceInfo) Source Type: news

Infections from tattoos not only happen because of poor hygiene practices, but also by contaminated tattoo inks. Talk to the artist about what tattoo inks they use. https://go.usa.gov/xy4q8   pic.twitter.com/qYyB6iklrf
Infections from tattoos not only happen because of poor hygiene practices, but also by contaminated tattoo inks. Talk to the artist about what tattoo inks they use. https://go.usa.gov/xy4q8  pic.twitter.com/qYyB6iklrf (Source: Food and Drug Adminstration (FDA): CDRHNew)
Source: Food and Drug Adminstration (FDA): CDRHNew - July 30, 2019 Category: Medical Devices Authors: ( at FDACosmetics) Source Type: news

#ICYMI #FDA https://twitter.com/FDACommissioner/status/1155937136324988929   …
#ICYMI #FDA https://twitter.com/FDACommissioner/status/1155937136324988929 … (Source: Food and Drug Adminstration (FDA): CDRHNew)
Source: Food and Drug Adminstration (FDA): CDRHNew - July 30, 2019 Category: Medical Devices Authors: ( at FDADeviceInfo) Source Type: news

#DYK https://twitter.com/US_FDA/status/1155870602495975424   …
#DYK https://twitter.com/US_FDA/status/1155870602495975424 … (Source: Food and Drug Adminstration (FDA): CDRHNew)
Source: Food and Drug Adminstration (FDA): CDRHNew - July 29, 2019 Category: Medical Devices Authors: ( at FDADeviceInfo) Source Type: news

#DYK Single use devices should not be reused? Your health care provider or emergency personnel may be able to assist you in obtaining a supply of single use devices during an emergency. Find out how to safely reuse multiple use devices: https://go.usa.gov/xPjCj  
#DYK Single use devices should not be reused? Your health care provider or emergency personnel may be able to assist you in obtaining a supply of single use devices during an emergency. Find out how to safely reuse multiple use devices: https://go.usa.gov/xPjCj  (Source: Food and Drug Adminstration (FDA): CDRHNew)
Source: Food and Drug Adminstration (FDA): CDRHNew - July 26, 2019 Category: Medical Devices Authors: ( at FDADeviceInfo) Source Type: news

NGS technology has the capability, as a single test, to accomplish what might have required several different tests in the past. More about FDA-ARGOS: https://go.usa.gov/xysa8   https://twitter.com/FDA_MCMi/status/1154752950599933953   …
NGS technology has the capability, as a single test, to accomplish what might have required several different tests in the past. More about FDA-ARGOS: https://go.usa.gov/xysa8  https://twitter.com/FDA_MCMi/status/1154752950599933953 … (Source: Food and Drug Adminstration (FDA): CDRHNew)
Source: Food and Drug Adminstration (FDA): CDRHNew - July 26, 2019 Category: Medical Devices Authors: ( at FDADeviceInfo) Source Type: news

More work needs to be done to address AMR concerns and together we can harness genomic data to help in this fight. https://twitter.com/FDA_MCMi/status/1154752952202125312   …
More work needs to be done to address AMR concerns and together we can harness genomic data to help in this fight. https://twitter.com/FDA_MCMi/status/1154752952202125312 … (Source: Food and Drug Adminstration (FDA): CDRHNew)
Source: Food and Drug Adminstration (FDA): CDRHNew - July 26, 2019 Category: Medical Devices Authors: ( at FDADeviceInfo) Source Type: news

The FDA team is looking for unique, hard-to-source microbes like biothreat organisms, emerging pathogens & AMR-related pathogens to help improve the FDA-ARGOS database. We encourage the community to share microbe sample here: https://bit.ly/31np2y2  
The FDA team is looking for unique, hard-to-source microbes like biothreat organisms, emerging pathogens & AMR-related pathogens to help improve the FDA-ARGOS database. We encourage the community to share microbe sample here: https://bit.ly/31np2y2  (Source: Food and Drug Adminstration (FDA): CDRHNew)
Source: Food and Drug Adminstration (FDA): CDRHNew - July 26, 2019 Category: Medical Devices Authors: ( at FDA_MCMi) Source Type: news

On July 23rd, the @US_FDA identified a Class I Recall, the most serious type of recall: Datascope/Getinge Recalls Cardiosave Hybrid, Cardiosave Rescue, CS300 and CS100/100i Intra-Aortic Balloon Pumps. Find out more about the recall: https://go.usa.gov/xyANK   #MedicalDevicepic.twitter.com/dQRmsCdJ5x
On July 23rd, the @US_FDA identified a Class I Recall, the most serious type of recall: Datascope/Getinge Recalls Cardiosave Hybrid, Cardiosave Rescue, CS300 and CS100/100i Intra-Aortic Balloon Pumps. Find out more about the recall: https://go.usa.gov/xyANK  #MedicalDevice pic.twitter.com/dQRmsCdJ5x (Source: Food and Drug Adminstration (FDA): CDRHNew)
Source: Food and Drug Adminstration (FDA): CDRHNew - July 25, 2019 Category: Medical Devices Authors: ( at FDADeviceInfo) Source Type: news

Reach out to your plastic surgeon, Allergan or contact our Division of Industry & Consumer Education for more information at dice@fda.hhs.gov if you have questions about the Allergan textured breast implant recall. #MedicalDevicepic.twitter.com/ci6ta6LiNg
Reach out to your plastic surgeon, Allergan or contact our Division of Industry & Consumer Education for more information at dice@fda.hhs.gov if you have questions about the Allergan textured breast implant recall. #MedicalDevice pic.twitter.com/ci6ta6LiNg (Source: Food and Drug Adminstration (FDA): CDRHNew)
Source: Food and Drug Adminstration (FDA): CDRHNew - July 25, 2019 Category: Medical Devices Authors: ( at FDADeviceInfo) Source Type: news

Recall Alert https://twitter.com/US_FDA/status/1154060607148253185   …
Recall Alert https://twitter.com/US_FDA/status/1154060607148253185 … (Source: Food and Drug Adminstration (FDA): CDRHNew)
Source: Food and Drug Adminstration (FDA): CDRHNew - July 24, 2019 Category: Medical Devices Authors: ( at FDADeviceInfo) Source Type: news

REMINDER https://twitter.com/FDADeviceInfo/status/1150810724081590272   …
REMINDER https://twitter.com/FDADeviceInfo/status/1150810724081590272 … (Source: Food and Drug Adminstration (FDA): CDRHNew)
Source: Food and Drug Adminstration (FDA): CDRHNew - July 22, 2019 Category: Medical Devices Authors: ( at FDADeviceInfo) Source Type: news

The @US_FDA has updated the Recognized Consensus Standards Database: https://go.usa.gov/xypBh  
The @US_FDA has updated the Recognized Consensus Standards Database: https://go.usa.gov/xypBh  (Source: Food and Drug Adminstration (FDA): CDRHNew)
Source: Food and Drug Adminstration (FDA): CDRHNew - July 19, 2019 Category: Medical Devices Authors: ( at FDADeviceInfo) Source Type: news

On Thursday August 22nd, the @US_FDA will host a webinar on the Final Guidance for the marketing clearance of diagnostic ultrasound systems and transducers. Find out more about the upcoming webinar: https://go.usa.gov/xypB2   #FDA #MedicalDevicepic.twitter.com/aZYsJVUYPI
On Thursday August 22nd, the @US_FDA will host a webinar on the Final Guidance for the marketing clearance of diagnostic ultrasound systems and transducers. Find out more about the upcoming webinar: https://go.usa.gov/xypB2  #FDA #MedicalDevice pic.twitter.com/aZYsJVUYPI (Source: Food and Drug Adminstration (FDA): CDRHNew)
Source: Food and Drug Adminstration (FDA): CDRHNew - July 19, 2019 Category: Medical Devices Authors: ( at FDADeviceInfo) Source Type: news

Today, the @US_FDA issued the Draft Guidance: Emergency Use Authorization of Medical Products and Related Authorities. Submit comments by August 19, 2019. Find out more about the guidance and how to submit comments: https://go.usa.gov/xypK6   #FDA #MedicalDevicepic.twitter.com/q92tHFQLlR
Today, the @US_FDA issued the Draft Guidance: Emergency Use Authorization of Medical Products and Related Authorities. Submit comments by August 19, 2019. Find out more about the guidance and how to submit comments: https://go.usa.gov/xypK6  #FDA #MedicalDevice pic.twitter.com/q92tHFQLlR (Source: Food and Drug Adminstration (FDA): CDRHNew)
Source: Food and Drug Adminstration (FDA): CDRHNew - July 18, 2019 Category: Medical Devices Authors: ( at FDADeviceInfo) Source Type: news

Today, the @US_FDA identified a Class I Recall, the most serious type of recall: Becton Dickinson recalls Alaris Infusion Sets for the Alaris Pump Model 8100 due to potential for tube collapse that may cause issues with medication delivery https://go.usa.gov/xypDT   #MedicalDevicepic.twitter.com/9bLlPV6YPe
Today, the @US_FDA identified a Class I Recall, the most serious type of recall: Becton Dickinson recalls Alaris Infusion Sets for the Alaris Pump Model 8100 due to potential for tube collapse that may cause issues with medication delivery https://go.usa.gov/xypDT  #MedicalDevice pic.twitter.com/9bLlPV6YPe (Source: Food and Drug Adminstration (FDA): CDRHNew)
Source: Food and Drug Adminstration (FDA): CDRHNew - July 18, 2019 Category: Medical Devices Authors: ( at FDADeviceInfo) Source Type: news

Today, the @US_FDA identified a Class I Recall, the most serious type of recall: Becton Dickinson recalls Alaris Pump Module Model 8100 Bezel Assembly. https://go.usa.gov/xypjG   #FDA #MedicalDevicepic.twitter.com/g9WQnodfNt
Today, the @US_FDA identified a Class I Recall, the most serious type of recall: Becton Dickinson recalls Alaris Pump Module Model 8100 Bezel Assembly. https://go.usa.gov/xypjG  #FDA #MedicalDevice pic.twitter.com/g9WQnodfNt (Source: Food and Drug Adminstration (FDA): CDRHNew)
Source: Food and Drug Adminstration (FDA): CDRHNew - July 18, 2019 Category: Medical Devices Authors: ( at FDADeviceInfo) Source Type: news

On July 17th, the @US_FDA identified a Class I Recall, the most serious type of recall: Teleflex Recalls NEONATAL ConchaSmart Breathing Circuit Due to Circuit Cracks- https://go.usa.gov/xypjr   #FDA #MedicalDevicepic.twitter.com/EUaOIHvIA2
On July 17th, the @US_FDA identified a Class I Recall, the most serious type of recall: Teleflex Recalls NEONATAL ConchaSmart Breathing Circuit Due to Circuit Cracks- https://go.usa.gov/xypjr  #FDA #MedicalDevice pic.twitter.com/EUaOIHvIA2 (Source: Food and Drug Adminstration (FDA): CDRHNew)
Source: Food and Drug Adminstration (FDA): CDRHNew - July 18, 2019 Category: Medical Devices Authors: ( at FDADeviceInfo) Source Type: news

#DYK July 12th was #NationalDifferentColoredEyesDay?! Be informed about eye safety if you wear contact lenses and check out the @US_FDA's information on everyday eye care. https://go.usa.gov/xyp37   pic.twitter.com/hzuvuX4Ylc
#DYK July 12th was #NationalDifferentColoredEyesDay?! Be informed about eye safety if you wear contact lenses and check out the @US_FDA's information on everyday eye care. https://go.usa.gov/xyp37  pic.twitter.com/hzuvuX4Ylc (Source: Food and Drug Adminstration (FDA): CDRHNew)
Source: Food and Drug Adminstration (FDA): CDRHNew - July 18, 2019 Category: Medical Devices Authors: ( at FDADeviceInfo) Source Type: news

The @US_FDA ’ s Software #FDAPreCert Program for #DigitalHealth is committed to a collaborative and transparent development process. Learn about the program ’ s progress, including relevant findings and outcomes of the testing so far. https://go.usa.gov/xyVJW   #MedicalDevicepic.twitter.com/p9eOKqyQYy
The @US_FDA’s Software #FDAPreCert Program for #DigitalHealth is committed to a collaborative and transparent development process. Learn about the program’s progress, including relevant findings and outcomes of the testing so far. https://go.usa.gov/xyVJW  #MedicalDevice pic.twitter.com/p9eOKqyQYy (Source: Food and Drug Adminstration (FDA): CDRHNew)
Source: Food and Drug Adminstration (FDA): CDRHNew - July 18, 2019 Category: Medical Devices Authors: ( at FDADeviceInfo) Source Type: news

To help health care providers better understand risks associated with CSF shunt valves and magnetic field interference from implanted hearing devices, the @US_FDA issued a Letter to Health Care Providers with recommendations. Read more: https://go.usa.gov/xymb6   #MedicalDevicepic.twitter.com/XVMmwAOgeH
To help health care providers better understand risks associated with CSF shunt valves and magnetic field interference from implanted hearing devices, the @US_FDA issued a Letter to Health Care Providers with recommendations. Read more: https://go.usa.gov/xymb6  #MedicalDevice pic.twitter.com/XVMmwAOgeH (Source: Food and Drug Adminstration (FDA): CDRHNew)
Source: Food and Drug Adminstration (FDA): CDRHNew - July 16, 2019 Category: Medical Devices Authors: ( at FDADeviceInfo) Source Type: news

REMINDER https://twitter.com/FDADeviceInfo/status/1149800062723268608   …
REMINDER https://twitter.com/FDADeviceInfo/status/1149800062723268608 … (Source: Food and Drug Adminstration (FDA): CDRHNew)
Source: Food and Drug Adminstration (FDA): CDRHNew - July 15, 2019 Category: Medical Devices Authors: ( at FDADeviceInfo) Source Type: news

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

On August 13, 2019 from 3-4:30 ET, the @US_FDA will host a webinar to provide developers and interested applicants an opportunity to hear from the FDA and answer questions about the challenges. https://go.usa.gov/xyPJG   pic.twitter.com/XKPcX6GgcB
On August 13, 2019 from 3-4:30 ET, the @US_FDA will host a webinar to provide developers and interested applicants an opportunity to hear from the FDA and answer questions about the challenges. https://go.usa.gov/xyPJG  pic.twitter.com/XKPcX6GgcB (Source: Food and Drug Adminstration (FDA): CDRHNew)
Source: Food and Drug Adminstration (FDA): CDRHNew - July 15, 2019 Category: Medical Devices Authors: ( at FDADeviceInfo) Source Type: news

As part of the @US_FDA ’ s ongoing effort to address the safety and 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. https://go.usa.gov/xyPJR   pic.twitter.com/oDXfFuSp6M
As part of the @US_FDA’s ongoing effort to address the safety and 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. https://go.usa.gov/xyPJR  pic.twitter.com/oDXfFuSp6M (Source: Food and Drug Adminstration (FDA): CDRHNew)
Source: Food and Drug Adminstration (FDA): CDRHNew - July 15, 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
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 - July 15, 2019 Category: Medical Devices Authors: ( at FDADeviceInfo) Source Type: news

Ethylene oxide sterilization is an important sterilization method that manufacturers widely use to keep medical devices safe.
(Source: Food and Drug Adminstration (FDA): CDRHNew)
Source: Food and Drug Adminstration (FDA): CDRHNew - July 15, 2019 Category: Medical Devices Authors: ( at FDADeviceInfo) Source Type: news

For many medical devices, sterilization with ethylene oxide may be the only method that effectively sterilizes and does not damage the device during the sterilization process.
For many medical devices, sterilization with ethylene oxide may be the only method that effectively sterilizes and does not damage the device during the sterilization process. (Source: Food and Drug Adminstration (FDA): CDRHNew)
Source: Food and Drug Adminstration (FDA): CDRHNew - July 15, 2019 Category: Medical Devices Authors: ( at FDADeviceInfo) Source Type: news

Medical devices made from certain polymers (plastic or resin), metals or glass, or that have multiple layers of packaging or hard-to-reach places (for example, catheters) are likely to be sterilized with ethylene oxide.
Medical devices made from certain polymers (plastic or resin), metals or glass, or that have multiple layers of packaging or hard-to-reach places (for example, catheters) are likely to be sterilized with ethylene oxide. (Source: Food and Drug Adminstration (FDA): CDRHNew)
Source: Food and Drug Adminstration (FDA): CDRHNew - July 15, 2019 Category: Medical Devices Authors: ( at FDADeviceInfo) Source Type: news

We're calling all biotech and medtech startups in the area to come out and hear from government officials and industry professionals as they offer their views and highlight best practices to help startups w/ navigating USPTO and FDA procedures. Visit: https://bit.ly/2KgCr5B  
We're calling all biotech and medtech startups in the area to come out and hear from government officials and industry professionals as they offer their views and highlight best practices to help startups w/ navigating USPTO and FDA procedures. Visit: https://bit.ly/2KgCr5B  (Source: Food and Drug Adminstration (FDA): CDRHNew)
Source: Food and Drug Adminstration (FDA): CDRHNew - July 12, 2019 Category: Medical Devices Authors: ( at FDADeviceInfo) Source Type: news