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

The program will provide more transparency to patients, physicians, and the medical device industry on how the FDA determines whether to approve an HDE application for a device that is meant to treat or diagnose populations w/ uncommon medical conditions. https://go.usa.gov/xV9Yx  
The program will provide more transparency to patients, physicians, and the medical device industry on how the FDA determines whether to approve an HDE application for a device that is meant to treat or diagnose populations w/ uncommon medical conditions. https://go.usa.gov/xV9Yx  (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

On September 5th, the @US_FDA issued a final guidance on Humanitarian Device Exemption (HDE) Program. #FDA #MedicalDevicepic.twitter.com/eeSFizymZ4
On September 5th, the @US_FDA issued a final guidance on Humanitarian Device Exemption (HDE) Program. #FDA #MedicalDevice pic.twitter.com/eeSFizymZ4 (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

Are your cosmetics “ FDA approved? ” Find out why there are no FDA approved cosmetics. https://go.usa.gov/xV9sw   pic.twitter.com/R6Ku9JSjsP
Are your cosmetics “FDA approved?” Find out why there are no FDA approved cosmetics. https://go.usa.gov/xV9sw  pic.twitter.com/R6Ku9JSjsP (Source: Food and Drug Adminstration (FDA): CDRHNew)
Source: Food and Drug Adminstration (FDA): CDRHNew - September 6, 2019 Category: Medical Devices Authors: ( at FDACosmetics) Source Type: news

Parents, trying to #declutter and get organized? It ’ s #babysafetymonth, so while you ’ re at it, take a look at this. It will remind you which things you want to keep up and away from children. #homesafety #upandaway ⁠ #BSM2019 ⁠ Download the checklist: http://bit.ly/2zTWCPN   ⁠ pic.twitter.com/WQcfBFngy6
Parents, trying to #declutter and get organized? It’s #babysafetymonth, so while you’re at it, take a look at this. It will remind you which things you want to keep up and away from children. #homesafety #upandaway⁠ #BSM2019 ⁠ Download the checklist: http://bit.ly/2zTWCPN  ⁠ pic.twitter.com/WQcfBFngy6 (Source: Food and Drug Adminstration (FDA): CDRHNew)
Source: Food and Drug Adminstration (FDA): CDRHNew - September 5, 2019 Category: Medical Devices Authors: ( at safekids) Source Type: news

Today the @US_FDA published a discussion paper: Consideration of Benefit-Risk Approaches for Weight-Loss Devices https://go.usa.gov/xV9ru   pic.twitter.com/qgZvR5Dwwo
Today the @US_FDA published a discussion paper: Consideration of Benefit-Risk Approaches for Weight-Loss Devices https://go.usa.gov/xV9ru  pic.twitter.com/qgZvR5Dwwo (Source: Food and Drug Adminstration (FDA): CDRHNew)
Source: Food and Drug Adminstration (FDA): CDRHNew - September 5, 2019 Category: Medical Devices Authors: ( at FDADeviceInfo) Source Type: news

This discussion paper describes a concept we are considering to assess the safety & effectiveness of weight-loss devices & highlights areas where we seek input from stakeholders. We are accepting comments for 90 days at http://Regulations.gov   under docket number FDA-2019-N-4060
This discussion paper describes a concept we are considering to assess the safety & effectiveness of weight-loss devices & highlights areas where we seek input from stakeholders. We are accepting comments for 90 days at http://Regulations.gov  under docket number FDA-2019-N-4060 (Source: Food and Drug Adminstration (FDA): CDRHNew)
Source: Food and Drug Adminstration (FDA): CDRHNew - September 5, 2019 Category: Medical Devices Authors: ( at FDADeviceInfo) Source Type: news

The test case research projects will explore if long-term real-world data from electronic health records can provide information to further the FDA ’ s understanding of adverse events. #MDICAPF2019 https://twitter.com/NESTccMedTech/status/1169621576544915456   …
The test case research projects will explore if long-term real-world data from electronic health records can provide information to further the FDA’s understanding of adverse events. #MDICAPF2019 https://twitter.com/NESTccMedTech/status/1169621576544915456 … (Source: Food and Drug Adminstration (FDA): CDRHNew)
Source: Food and Drug Adminstration (FDA): CDRHNew - September 5, 2019 Category: Medical Devices Authors: ( at FDADeviceInfo) Source Type: news

A national evaluation system for health technology will help improve the quality of real-world evidence that can be used to make better informed treatment decisions & strike the right balance between assuring safety and fostering device innovation & patient access #MDICAPF2019 https://twitter.com/MDICAnnualForum/status/1169603314511745025   …
A national evaluation system for health technology will help improve the quality of real-world evidence that can be used to make better informed treatment decisions & strike the right balance between assuring safety and fostering device innovation & patient access #MDICAPF2019 https://twitter.com/MDICAnnualForum/status/1169603314511745025 … (Source: Food and Drug Adminstration (FDA): CDRHNew)
Source: Food and Drug Adminstration (FDA): CDRHNew - September 5, 2019 Category: Medical Devices Authors: ( at FDADeviceInfo) Source Type: news

Don ’ t forget to join the @US_FDA next Tuesday, Sept 10, 2019 for a meeting of the Patient Engagement Advisory Committee. https://go.usa.gov/xV8Xf   #PEAC #cybersecurity
Don’t forget to join the @US_FDA next Tuesday, Sept 10, 2019 for a meeting of the Patient Engagement Advisory Committee. https://go.usa.gov/xV8Xf  #PEAC #cybersecurity (Source: Food and Drug Adminstration (FDA): CDRHNew)
Source: Food and Drug Adminstration (FDA): CDRHNew - September 4, 2019 Category: Medical Devices Authors: ( at FDADeviceInfo) Source Type: news

Is it the first day of school for the kids today? Don ’ t forget that a healthy breakfast is an important part of going #BackToSchool! https://go.usa.gov/xVB4S   pic.twitter.com/r7wgNgZ0c2
Is it the first day of school for the kids today? Don’t forget that a healthy breakfast is an important part of going #BackToSchool! https://go.usa.gov/xVB4S  pic.twitter.com/r7wgNgZ0c2 (Source: Food and Drug Adminstration (FDA): CDRHNew)
Source: Food and Drug Adminstration (FDA): CDRHNew - September 3, 2019 Category: Medical Devices Authors: ( at US_FDA) Source Type: news

If you live in the path of Hurricane #Dorian, take steps now to be prepared. https://go.usa.gov/xU7f8   #HurricaneDorian2019pic.twitter.com/tcYq8K4lft
If you live in the path of Hurricane #Dorian, take steps now to be prepared. https://go.usa.gov/xU7f8  #HurricaneDorian2019 pic.twitter.com/tcYq8K4lft (Source: Food and Drug Adminstration (FDA): CDRHNew)
Source: Food and Drug Adminstration (FDA): CDRHNew - September 2, 2019 Category: Medical Devices Authors: ( at HHSGov) Source Type: news

Today, the @US_FDA issued the final guidance titled, Consideration of Uncertainty in Making Benefit-Risk Determinations in Medical Device Premarket Approvals, De Novo Classifications, and Humanitarian Device Exemptions. Find out more about the guidance: https://go.usa.gov/xVBCG   pic.twitter.com/EAchboXwxr
Today, the @US_FDA issued the final guidance titled, Consideration of Uncertainty in Making Benefit-Risk Determinations in Medical Device Premarket Approvals, De Novo Classifications, and Humanitarian Device Exemptions. Find out more about the guidance: https://go.usa.gov/xVBCG  pic.twitter.com/EAchboXwxr (Source: Food and Drug Adminstration (FDA): CDRHNew)
Source: Food and Drug Adminstration (FDA): CDRHNew - August 30, 2019 Category: Medical Devices Authors: ( at FDADeviceInfo) Source Type: news

Today, the @US_FDA issued the final guidance titled, Factors to Consider When Making Benefit-Risk Determinations in Medical Device Premarket Approval and De Novo Classifications. Find out more about the guidance: https://go.usa.gov/xVBCr   #MedicalDevice #FDApic.twitter.com/ElqmRdVdRA
Today, the @US_FDA issued the final guidance titled, Factors to Consider When Making Benefit-Risk Determinations in Medical Device Premarket Approval and De Novo Classifications. Find out more about the guidance: https://go.usa.gov/xVBCr  #MedicalDevice #FDA pic.twitter.com/ElqmRdVdRA (Source: Food and Drug Adminstration (FDA): CDRHNew)
Source: Food and Drug Adminstration (FDA): CDRHNew - August 30, 2019 Category: Medical Devices Authors: ( at FDADeviceInfo) Source Type: news

Los dispositivos m é dicos pueden verse afectados por un corte de energ í a por fuertes lluvias e inundaciones a causa de #Dorian. Consulte nuestros consejos sobre c ó mo prepararse y qu é hacer si se ve afectado, incluyendo, el uso seguro de un generador: https://go.usa.gov/xVZDc   pic.twitter.com/Xi3FHyMNHZ
Los dispositivos médicos pueden verse afectados por un corte de energía por fuertes lluvias e inundaciones a causa de #Dorian. Consulte nuestros consejos sobre cómo prepararse y qué hacer si se ve afectado, incluyendo, el uso seguro de un generador: https://go.usa.gov/xVZDc  pic.twitter.com/Xi3FHyMNHZ (Source: Food and Drug Adminstration (FDA): CDRHNew)
Source: Food and Drug Adminstration (FDA): CDRHNew - August 29, 2019 Category: Medical Devices Authors: ( at FDAenEspanol) Source Type: news

We plan to hold an advisory committee meeting later this year to discuss options to improve reprocessing & new device designs or technology to reduce infection transmission by duodenoscopes.
We plan to hold an advisory committee meeting later this year to discuss options to improve reprocessing & new device designs or technology to reduce infection transmission by duodenoscopes. (Source: Food and Drug Adminstration (FDA): CDRHNew)
Source: Food and Drug Adminstration (FDA): CDRHNew - August 29, 2019 Category: Medical Devices Authors: ( at FDADeviceInfo) Source Type: news

These actions are part of our continued effort to protect patient safety. We will continue to keep the public informed when significant new information becomes available. #MedicalDevice #FDA
(Source: Food and Drug Adminstration (FDA): CDRHNew)
Source: Food and Drug Adminstration (FDA): CDRHNew - August 29, 2019 Category: Medical Devices Authors: ( at FDADeviceInfo) Source Type: news

We are warning health care facilities that adenosine triphosphate (ATP) test strips should not be used to assess duodenoscope cleaning. To date, the FDA has not evaluated them for effectiveness for assessing duodenoscope reprocessing.
We are warning health care facilities that adenosine triphosphate (ATP) test strips should not be used to assess duodenoscope cleaning. To date, the FDA has not evaluated them for effectiveness for assessing duodenoscope reprocessing. (Source: Food and Drug Adminstration (FDA): CDRHNew)
Source: Food and Drug Adminstration (FDA): CDRHNew - August 29, 2019 Category: Medical Devices Authors: ( at FDADeviceInfo) Source Type: news

Manufacturers of ATP test strips are advised to submit data to support the legal marketing of these strips for this use.
(Source: Food and Drug Adminstration (FDA): CDRHNew)
Source: Food and Drug Adminstration (FDA): CDRHNew - August 29, 2019 Category: Medical Devices Authors: ( at FDADeviceInfo) Source Type: news

We have ordered manufacturers of duodenoscopes with disposable endcaps to conduct postmarket surveillance studies to gather more information and verify the new designs reduce the contamination rate: https://go.usa.gov/xVZTn  
We have ordered manufacturers of duodenoscopes with disposable endcaps to conduct postmarket surveillance studies to gather more information and verify the new designs reduce the contamination rate: https://go.usa.gov/xVZTn  (Source: Food and Drug Adminstration (FDA): CDRHNew)
Source: Food and Drug Adminstration (FDA): CDRHNew - August 29, 2019 Category: Medical Devices Authors: ( at FDADeviceInfo) Source Type: news

Upon completion of these studies, we expect the labeling on duodenoscopes w/ disposable endcaps to be updated w/ contamination rate data to allow patients & health care professionals to make informed decisions about the potential risks associated w /duodenoscopes
Upon completion of these studies, we expect the labeling on duodenoscopes w/ disposable endcaps to be updated w/ contamination rate data to allow patients & health care professionals to make informed decisions about the potential risks associated w /duodenoscopes (Source: Food and Drug Adminstration (FDA): CDRHNew)
Source: Food and Drug Adminstration (FDA): CDRHNew - August 29, 2019 Category: Medical Devices Authors: ( at FDADeviceInfo) Source Type: news

Patients are reminded that the risk of infection from inadequate reprocessing is relatively low and you should not cancel or delay any planned procedure without first discussing with your health care provider.
(Source: Food and Drug Adminstration (FDA): CDRHNew)
Source: Food and Drug Adminstration (FDA): CDRHNew - August 29, 2019 Category: Medical Devices Authors: ( at FDADeviceInfo) Source Type: news

We are recommending that duodenoscope manufacturers and health care facilities begin gradually transitioning to duodenoscopes with disposable components to reduce the risk of patient infection.
(Source: Food and Drug Adminstration (FDA): CDRHNew)
Source: Food and Drug Adminstration (FDA): CDRHNew - August 29, 2019 Category: Medical Devices Authors: ( at FDADeviceInfo) Source Type: news

We are encouraging device manufacturers to develop innovative approaches for the entire duodenoscope reprocessing procedure to reduce the risk of patient infection.
(Source: Food and Drug Adminstration (FDA): CDRHNew)
Source: Food and Drug Adminstration (FDA): CDRHNew - August 29, 2019 Category: Medical Devices Authors: ( at FDADeviceInfo) Source Type: news

The @US_FDA takes the risk of patient infection very seriously & continues to take steps to help improve the effectiveness of duodenoscope reprocessing. Today, we are sharing several updates https://go.usa.gov/xVZTK   including:pic.twitter.com/TSOrqZrkdm
The @US_FDA takes the risk of patient infection very seriously & continues to take steps to help improve the effectiveness of duodenoscope reprocessing. Today, we are sharing several updates https://go.usa.gov/xVZTK  including: pic.twitter.com/TSOrqZrkdm (Source: Food and Drug Adminstration (FDA): CDRHNew)
Source: Food and Drug Adminstration (FDA): CDRHNew - August 29, 2019 Category: Medical Devices Authors: ( at FDADeviceInfo) Source Type: news

Get help before, during and after Hurricane #Dorian with the FEMA app: Get safety tips for every stage of the storm Look up emergency shelter locations Sign up for localized @NWS weather alerts (up to 5 locations). Download: http://fema.gov/mobile-app   pic.twitter.com/OyMPHqwIpF
Get help before, during and after Hurricane #Dorian with the FEMA app: Get safety tips for every stage of the storm Look up emergency shelter locations Sign up for localized @NWS weather alerts (up to 5 locations). Download: http://fema.gov/mobile-app  pic.twitter.com/OyMPHqwIpF (Source: Food and Drug Adminstration (FDA): CDRHNew)
Source: Food and Drug Adminstration (FDA): CDRHNew - August 29, 2019 Category: Medical Devices Authors: ( at fema) Source Type: news

Consejo de seguridad ante #Dorian: Si usted est á usando un generador port á til de , siempre debe estar fuera de su casa o negocio - y por lo menos a 20 pies de las ventanas/puertas. #PR #USVIpic.twitter.com/qBHm0Jh9Gb
Consejo de seguridad ante #Dorian: Si usted está usando un generador portátil de , siempre debe estar fuera de su casa o negocio - y por lo menos a 20 pies de las ventanas/puertas. #PR #USVI pic.twitter.com/qBHm0Jh9Gb (Source: Food and Drug Adminstration (FDA): CDRHNew)
Source: Food and Drug Adminstration (FDA): CDRHNew - August 29, 2019 Category: Medical Devices Authors: ( at femaregion2) Source Type: news

Also check out our tips for using a generator to restore power to medical devices that may be impacted by a power outage caused by heavy rain and flooding from #Dorian: https://go.usa.gov/xPjau   https://twitter.com/US_FDA/status/1166696937053138945   …
Also check out our tips for using a generator to restore power to medical devices that may be impacted by a power outage caused by heavy rain and flooding from #Dorian: https://go.usa.gov/xPjau  https://twitter.com/US_FDA/status/1166696937053138945 … (Source: Food and Drug Adminstration (FDA): CDRHNew)
Source: Food and Drug Adminstration (FDA): CDRHNew - August 28, 2019 Category: Medical Devices Authors: ( at FDADeviceInfo) Source Type: news

Don't forget! There's still time to register for the 7th Annual Scientific Computing Days at the FDA. https://twitter.com/US_FDA/status/1164522612094930946   …
Don't forget! There's still time to register for the 7th Annual Scientific Computing Days at the FDA. https://twitter.com/US_FDA/status/1164522612094930946 … (Source: Food and Drug Adminstration (FDA): CDRHNew)
Source: Food and Drug Adminstration (FDA): CDRHNew - August 28, 2019 Category: Medical Devices Authors: ( at US_FDA) Source Type: news

We ’ re approaching the peak of hurricane season. If you use a #MedicalDevice that could be affected by a power outage caused by heavy rain & flooding, the @US_FDA wants you to check out our tips for using a generator to restore power to your device: https://go.usa.gov/xPjau   #Dorianpic.twitter.com/m7wzhsgyt2
We’re approaching the peak of hurricane season. If you use a #MedicalDevice that could be affected by a power outage caused by heavy rain &flooding, the @US_FDA wants you to check out our tips for using a generator to restore power to your device: https://go.usa.gov/xPjau  #Dorian pic.twitter.com/m7wzhsgyt2 (Source: Food and Drug Adminstration (FDA): CDRHNew)
Source: Food and Drug Adminstration (FDA): CDRHNew - August 27, 2019 Category: Medical Devices Authors: ( at FDADeviceInfo) Source Type: news

#Dorian https://twitter.com/FEMAespanol/status/1166074297028423686   …
#Dorian https://twitter.com/FEMAespanol/status/1166074297028423686 … (Source: Food and Drug Adminstration (FDA): CDRHNew)
Source: Food and Drug Adminstration (FDA): CDRHNew - August 27, 2019 Category: Medical Devices Authors: ( at FDADeviceInfo) Source Type: news

#TuesdayThoughts https://twitter.com/FDA_Drug_Info/status/1166358160157958145   …
#TuesdayThoughts https://twitter.com/FDA_Drug_Info/status/1166358160157958145 … (Source: Food and Drug Adminstration (FDA): CDRHNew)
Source: Food and Drug Adminstration (FDA): CDRHNew - August 27, 2019 Category: Medical Devices Authors: ( at FDADeviceInfo) Source Type: news

Prepare now, it ’ s not too late - FDA's advice on #foodsafety in case you lose power ⇨ https://go.usa.gov/xVjzA   #Dorianpic.twitter.com/RottAPV4Jl
Prepare now, it’s not too late - FDA's advice on #foodsafety in case you lose power ⇨ https://go.usa.gov/xVjzA  #Dorian pic.twitter.com/RottAPV4Jl (Source: Food and Drug Adminstration (FDA): CDRHNew)
Source: Food and Drug Adminstration (FDA): CDRHNew - August 27, 2019 Category: Medical Devices Authors: ( at FDAfood) Source Type: news

M á s consejos para prepararse para #Dorian: Guarde documentos importantes en un lugar seguro y aprueba de agua. Mant é ngase informado con informaci ó n oficial de las autoridades locales y @NHC_Atlantic. Recuerde estar en comunicaci ó n con sus vecinos. https://youtu.be/_BbKGRRcr0E  
Más consejos para prepararse para #Dorian: Guarde documentos importantes en un lugar seguro y aprueba de agua. Manténgase informado con información oficial de las autoridades locales y @NHC_Atlantic. Recuerde estar en comunicación con sus vecinos. https://youtu.be/_BbKGRRcr0E  (Source: Food and Drug Adminstration (FDA): CDRHNew)
Source: Food and Drug Adminstration (FDA): CDRHNew - August 27, 2019 Category: Medical Devices Authors: ( at FEMAespanol) Source Type: news

The FDA is sharing recommendations of " What to Know When Buying or Using a Breast Pumps " #medicaldevice #NBM19 https://twitter.com/US_FDA/status/1163888681192701952   …
The FDA is sharing recommendations of "What to Know When Buying or Using a Breast Pumps" #medicaldevice #NBM19 https://twitter.com/US_FDA/status/1163888681192701952 … (Source: Food and Drug Adminstration (FDA): CDRHNew)
Source: Food and Drug Adminstration (FDA): CDRHNew - August 26, 2019 Category: Medical Devices Authors: ( at FDADeviceInfo) Source Type: news

#ICYMI - FDA approved the first posterior non-fusion #medicaldevice to treat adolescents w/idiopathic scoliosis. https://twitter.com/FDAMedia/status/1164985659435696129   …
#ICYMI - FDA approved the first posterior non-fusion #medicaldevice to treat adolescents w/idiopathic scoliosis. https://twitter.com/FDAMedia/status/1164985659435696129 … (Source: Food and Drug Adminstration (FDA): CDRHNew)
Source: Food and Drug Adminstration (FDA): CDRHNew - August 26, 2019 Category: Medical Devices Authors: ( at FDADeviceInfo) Source Type: news

CDRH's regulatory science priorities serve as a catalyst to improve the safety, effectiveness, performance, & quality of medical devices & radiation-emitting products, & facilitate introducing innovative medical devices. Find out more about the priorities: https://go.usa.gov/xVTWk  
CDRH's regulatory science priorities serve as a catalyst to improve the safety, effectiveness, performance, & quality of medical devices & radiation-emitting products, & facilitate introducing innovative medical devices. Find out more about the priorities: https://go.usa.gov/xVTWk  (Source: Food and Drug Adminstration (FDA): CDRHNew)
Source: Food and Drug Adminstration (FDA): CDRHNew - August 23, 2019 Category: Medical Devices Authors: ( at FDADeviceInfo) Source Type: news

Don't wear your contact lenses or use your case for longer than recommended. Check out the @US_FDA's tips on contact lens care: https://go.usa.gov/xVYbA   #OnePairTakeCarepic.twitter.com/oT5CYPZaEP
Don't wear your contact lenses or use your case for longer than recommended. Check out the @US_FDA's tips on contact lens care: https://go.usa.gov/xVYbA  #OnePairTakeCare pic.twitter.com/oT5CYPZaEP (Source: Food and Drug Adminstration (FDA): CDRHNew)
Source: Food and Drug Adminstration (FDA): CDRHNew - August 23, 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: Edwards Lifesciences, LLC, Recalls SAPIEN 3 Ultra Delivery System Due to Burst Balloons During Surgery. Find out more about the recall: https://go.usa.gov/xV2Wm   #MedicalDevicepic.twitter.com/Wo3BAbDGlF
Today, the @US_FDA identified a Class I Recall, the most serious type of recall: Edwards Lifesciences, LLC, Recalls SAPIEN 3 Ultra Delivery System Due to Burst Balloons During Surgery. Find out more about the recall: https://go.usa.gov/xV2Wm  #MedicalDevice pic.twitter.com/Wo3BAbDGlF (Source: Food and Drug Adminstration (FDA): CDRHNew)
Source: Food and Drug Adminstration (FDA): CDRHNew - August 22, 2019 Category: Medical Devices Authors: ( at FDADeviceInfo) Source Type: news

Recall #1: Medline Industries, Inc., Recalls Centurion Medical Products' Primary Warmer Pack and Primary Set Pack Containing Becton Dickinson Alaris Pump Model 8100 Infusion Sets. Find out more about the recall: https://go.usa.gov/xV2Ds   #MedicalDevice
Recall #1: Medline Industries, Inc., Recalls Centurion Medical Products' Primary Warmer Pack and Primary Set Pack Containing Becton Dickinson Alaris Pump Model 8100 Infusion Sets. Find out more about the recall: https://go.usa.gov/xV2Ds  #MedicalDevice (Source: Food and Drug Adminstration (FDA): CDRHNew)
Source: Food and Drug Adminstration (FDA): CDRHNew - August 22, 2019 Category: Medical Devices Authors: ( at FDADeviceInfo) Source Type: news

Recall #2: Medline Industries, Inc., Recalls Centurion Medical Products' Primary Warmer Pack and Primary Set Pack Containing Becton Dickinson Alaris Pump Model 8100 Infusion Sets Find out more about the recall: https://go.usa.gov/xV2Wx   #MedicalDevice
Recall #2: Medline Industries, Inc., Recalls Centurion Medical Products' Primary Warmer Pack and Primary Set Pack Containing Becton Dickinson Alaris Pump Model 8100 Infusion Sets Find out more about the recall: https://go.usa.gov/xV2Wx  #MedicalDevice (Source: Food and Drug Adminstration (FDA): CDRHNew)
Source: Food and Drug Adminstration (FDA): CDRHNew - August 22, 2019 Category: Medical Devices Authors: ( at FDADeviceInfo) Source Type: news

On August 21st, the @US_FDA identified two Class I Recalls, the most serious type of recall. Use of these devices may cause serious injuries or death.pic.twitter.com/bzGMToezPx
On August 21st, the @US_FDA identified two Class I Recalls, the most serious type of recall. Use of these devices may cause serious injuries or death. pic.twitter.com/bzGMToezPx (Source: Food and Drug Adminstration (FDA): CDRHNew)
Source: Food and Drug Adminstration (FDA): CDRHNew - August 22, 2019 Category: Medical Devices Authors: ( at FDADeviceInfo) Source Type: news

#ICYMI #OnePairTakeCare https://twitter.com/CDCgov/status/1164210057237712896   …
#ICYMI #OnePairTakeCare https://twitter.com/CDCgov/status/1164210057237712896 … (Source: Food and Drug Adminstration (FDA): CDRHNew)
Source: Food and Drug Adminstration (FDA): CDRHNew - August 22, 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 Marketing Clearance of Diagnostic Ultrasound Systems and Transducers Final Guidance, the transcript and recording will be available on August 30th https://go.usa.gov/xV246  
If you were unable to participate in today’s CDRH webinar where we reviewed and answered questions about the Marketing Clearance of Diagnostic Ultrasound Systems and Transducers Final Guidance, the transcript and recording will be available on August 30th https://go.usa.gov/xV246  (Source: Food and Drug Adminstration (FDA): CDRHNew)
Source: Food and Drug Adminstration (FDA): CDRHNew - August 22, 2019 Category: Medical Devices Authors: ( at FDADeviceInfo) Source Type: news

We ’ re getting ready for our webinar on the Marketing Clearance of Diagnostic Ultrasound Systems & Transducers Final Guidance. We look fwd to connecting w/ device manufacturers & industry to discuss & answer questions about the guidance. Join us at 1 pm EDT http://go.usa.gov/xypB2   pic.twitter.com/UuWxuYcNHM
We’re getting ready for our webinar on the Marketing Clearance of Diagnostic Ultrasound Systems & Transducers Final Guidance. We look fwd to connecting w/ device manufacturers & industry to discuss & answer questions about the guidance. Join us at 1 pm EDT http://go.usa.gov/xypB2  pic.twitter.com/UuWxuYcNHM (Source: Food and Drug Adminstration (FDA): CDRHNew)
Source: Food and Drug Adminstration (FDA): CDRHNew - August 22, 2019 Category: Medical Devices Authors: ( at FDADeviceInfo) Source Type: news

If you use a #MedicalDevice affected by a power outage caused by a natural disaster, check out the #FDA ’ s tips for using a generator to restore power to your device: https://go.usa.gov/xPjau  
If you use a #MedicalDevice affected by a power outage caused by a natural disaster, check out the #FDA’s tips for using a generator to restore power to your device: https://go.usa.gov/xPjau  (Source: Food and Drug Adminstration (FDA): CDRHNew)
Source: Food and Drug Adminstration (FDA): CDRHNew - August 21, 2019 Category: Medical Devices Authors: ( at FDADeviceInfo) Source Type: news

REMINDER: 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 tomorrow's webinar: https://go.usa.gov/xypB2   #FDA #MedicalDevicepic.twitter.com/Cs3M7Csvcd
REMINDER: 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 tomorrow's webinar: https://go.usa.gov/xypB2  #FDA #MedicalDevice pic.twitter.com/Cs3M7Csvcd (Source: Food and Drug Adminstration (FDA): CDRHNew)
Source: Food and Drug Adminstration (FDA): CDRHNew - August 21, 2019 Category: Medical Devices Authors: ( at FDADeviceInfo) Source Type: news

It's back to school season and we're wishing everyone a safe and awesome school year. Check out the @US_FDA's Cool Tips For Kids As They Return to School: https://go.usa.gov/xVgYw   pic.twitter.com/S5iQseqegu
It's back to school season and we're wishing everyone a safe and awesome school year. Check out the @US_FDA's Cool Tips For Kids As They Return to School: https://go.usa.gov/xVgYw  pic.twitter.com/S5iQseqegu (Source: Food and Drug Adminstration (FDA): CDRHNew)
Source: Food and Drug Adminstration (FDA): CDRHNew - August 20, 2019 Category: Medical Devices Authors: ( at FDADeviceInfo) Source Type: news

#ICYMI #OnePairTakeCare https://twitter.com/CDCgov/status/1163551458978979841   …
#ICYMI #OnePairTakeCare https://twitter.com/CDCgov/status/1163551458978979841 … (Source: Food and Drug Adminstration (FDA): CDRHNew)
Source: Food and Drug Adminstration (FDA): CDRHNew - August 20, 2019 Category: Medical Devices Authors: ( at FDADeviceInfo) Source Type: news

It ’ s Contact Lens Health Week. The @US_FDA and @CDCGov encourages wearers of contact lenses to practice healthy wear and care habits. Check out the FDA's tips on contact lens care: https://go.usa.gov/xVYbA   #OnePairTakeCarepic.twitter.com/Jbvmua8o4w
It’s Contact Lens Health Week. The @US_FDA and @CDCGov encourages wearers of contact lenses to practice healthy wear and care habits. Check out the FDA's tips on contact lens care: https://go.usa.gov/xVYbA  #OnePairTakeCare pic.twitter.com/Jbvmua8o4w (Source: Food and Drug Adminstration (FDA): CDRHNew)
Source: Food and Drug Adminstration (FDA): CDRHNew - August 19, 2019 Category: Medical Devices Authors: ( at FDADeviceInfo) Source Type: news