On Tuesday July 16th from 12-6 PM PT, @USPTO and @US_FDA in collaboration with @BiocomCA will host “ Strategies for Biotech/Medtech Startups: Successfully Navigating the USPTO and FDA.pic.twitter.com/25sq0UTs54
On Tuesday July 16th from 12-6 PM PT, @USPTO and @US_FDA in collaboration with @BiocomCA will host “Strategies for Biotech/Medtech Startups: Successfully Navigating the USPTO and FDA. pic.twitter.com/25sq0UTs54 (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

Today, the @US_FDA identified a Class I Recall, the most serious type of recall: Hamilton Medical AG Recalls Hamilton-G5 Ventilators Due to Potential for Sporadic Error Message Resulting in the Ventilator to Cease Ventilation https://go.usa.gov/xyQB2   #FDA #MedicalDevicepic.twitter.com/ZWGU9P6p8k
Today, the @US_FDA identified a Class I Recall, the most serious type of recall: Hamilton Medical AG Recalls Hamilton-G5 Ventilators Due to Potential for Sporadic Error Message Resulting in the Ventilator to Cease Ventilation https://go.usa.gov/xyQB2  #FDA #MedicalDevice pic.twitter.com/ZWGU9P6p8k (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

Today, the @US_FDA identified a Class I Recall, the most serious type of recall: GE Healthcare, LLC Recalls Giraffe Infant Warmers and Panda i-Res Infant Warmers Due to Bedside Panels and Latch Areas Cracking or Breaking. https://go.usa.gov/xyQB4   #FDA #MedicalDevicepic.twitter.com/ICxyzZpStz
Today, the @US_FDA identified a Class I Recall, the most serious type of recall: GE Healthcare, LLC Recalls Giraffe Infant Warmers and Panda i-Res Infant Warmers Due to Bedside Panels and Latch Areas Cracking or Breaking. https://go.usa.gov/xyQB4  #FDA #MedicalDevice pic.twitter.com/ICxyzZpStz (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

On July 4, 2019, the @US_FDA ’ s Dr. Binita Ashar shared the following updates related to the #FDA's activities during an international meeting on #breastimplants in Amsterdam, the Netherlands. https://www.youtube.com/watch?v=t3Y1kxQQtf8   …
On July 4, 2019, the @US_FDA’s Dr. Binita Ashar shared the following updates related to the #FDA's activities during an international meeting on #breastimplants in Amsterdam, the Netherlands. https://www.youtube.com/watch?v=t3Y1kxQQtf8 … (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

.@US_FDA Published the FY19, Q3 Performance Metrics for Accredited Third Party Reviewers of 510(k) Submissions. Read more at https://go.usa.gov/xynth   #FDA #MedicalDevice
. @US_FDA Published the FY19, Q3 Performance Metrics for Accredited Third Party Reviewers of 510(k) Submissions. Read more at https://go.usa.gov/xynth  #FDA #MedicalDevice (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

Hurricane season is here and if you use a #MedicalDevice that could be affected by a power outage caused by heavy rain and 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   #Barrypic.twitter.com/uEclrmTjZG
Hurricane season is here and if you use a #MedicalDevice that could be affected by a power outage caused by heavy rain and 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  #Barry pic.twitter.com/uEclrmTjZG (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

Prepare for severe weather before it strikes. Use this step-by-step guide to protect yourself and your loved ones. http://bit.ly/2S9Ueg2   #TropicalStormBarry #FridayMotivation #FridayThoughtspic.twitter.com/6hXQpdpSa9
Prepare for severe weather before it strikes. Use this step-by-step guide to protect yourself and your loved ones. http://bit.ly/2S9Ueg2  #TropicalStormBarry #FridayMotivation #FridayThoughts pic.twitter.com/6hXQpdpSa9 (Source: Food and Drug Adminstration (FDA): CDRHNew)
Source: Food and Drug Adminstration (FDA): CDRHNew - July 12, 2019 Category: Medical Devices Authors: ( at HHSGov) Source Type: news

Heavy rains & high winds within the next 24 hours may cause flooding along the central Gulf Coast. If you're in the path of Tropical Storm Barry it ’ s NOT too late to make sure your food stays safe! Tips you need to know here: http://go.usa.gov/xyNJZ   pic.twitter.com/4ZfIezQa2A
Heavy rains & high winds within the next 24 hours may cause flooding along the central Gulf Coast. If you're in the path of Tropical Storm Barry it’s NOT too late to make sure your food stays safe! Tips you need to know here: http://go.usa.gov/xyNJZ  pic.twitter.com/4ZfIezQa2A (Source: Food and Drug Adminstration (FDA): CDRHNew)
Source: Food and Drug Adminstration (FDA): CDRHNew - July 12, 2019 Category: Medical Devices Authors: ( at USDAFoodSafety) Source Type: news

#FDA, along with other agencies, is closely monitoring Tropical Storm #Barry, including the danger of storm surges along parts of the Louisiana coast. We stand ready to provide information & assistance to impacted communities & we will provide updates as the storms develop. https://twitter.com/NHC_Atlantic/status/1149336113066196992   …
#FDA, along with other agencies, is closely monitoring Tropical Storm #Barry, including the danger of storm surges along parts of the Louisiana coast. We stand ready to provide information & assistance to impacted communities & we will provide updates as the storms develop. https://twitter.com/NHC_Atlantic/status/1149336113066196992 … (Source: Food and Drug Adminstration (FDA): CDRHNew)
Source: Food and Drug Adminstration (FDA): CDRHNew - July 11, 2019 Category: Medical Devices Authors: ( at US_FDA) Source Type: news

This is the first MDDT developed by researchers in the FDA ’ s Office of Science and Engineering Laboratories. It is also the first nonclinical assessment model qualified through the MDDT program. Find out more: https://go.usa.gov/xyRrp   #FDA #MedicalDevice
This is the first MDDT developed by researchers in the FDA’s Office of Science and Engineering Laboratories. It is also the first nonclinical assessment model qualified through the MDDT program. Find out more: https://go.usa.gov/xyRrp  #FDA #MedicalDevice (Source: Food and Drug Adminstration (FDA): CDRHNew)
Source: Food and Drug Adminstration (FDA): CDRHNew - July 11, 2019 Category: Medical Devices Authors: ( at FDADeviceInfo) Source Type: news

The @US_FDA has qualified a new Medical Device Development Tool (MDDT). High Intensity Therapeutic Ultrasound (HITU) developers can use this newly qualified tool to test safety and the effects of HITU in a preclinical setting using “ phantoms ” that mimic human tissuepic.twitter.com/7azvIYlwr6
The @US_FDA has qualified a new Medical Device Development Tool (MDDT). High Intensity Therapeutic Ultrasound (HITU) developers can use this newly qualified tool to test safety and the effects of HITU in a preclinical setting using “phantoms” that mimic human tissue pic.twitter.com/7azvIYlwr6 (Source: Food and Drug Adminstration (FDA): CDRHNew)
Source: Food and Drug Adminstration (FDA): CDRHNew - July 11, 2019 Category: Medical Devices Authors: ( at FDADeviceInfo) Source Type: news

FDA issued final guidance on live case presentations in device trials, which can help increase awareness of/enrollment in a study. This guidance gives FDA recommendations that work to ensure patient protection during device trials using live case demos. https://go.usa.gov/xyXnx   pic.twitter.com/gSkMI5hECC
FDA issued final guidance on live case presentations in device trials, which can help increase awareness of/enrollment in a study. This guidance gives FDA recommendations that work to ensure patient protection during device trials using live case demos. https://go.usa.gov/xyXnx  pic.twitter.com/gSkMI5hECC (Source: Food and Drug Adminstration (FDA): CDRHNew)
Source: Food and Drug Adminstration (FDA): CDRHNew - July 10, 2019 Category: Medical Devices Authors: ( at FDAMedia) Source Type: news

It ’ s National #MinorityMentalHealth Month! Do you have resources to help improve minority #MentalHealth? Let ’ s share our knowledge, tools, & resources during the #MinorityMH chat on July 24, 2-3pm ET!pic.twitter.com/didyXmqtOO
It’s National #MinorityMentalHealth Month! Do you have resources to help improve minority #MentalHealth? Let’s share our knowledge, tools, & resources during the #MinorityMH chat on July 24, 2-3pm ET! pic.twitter.com/didyXmqtOO (Source: Food and Drug Adminstration (FDA): CDRHNew)
Source: Food and Drug Adminstration (FDA): CDRHNew - July 10, 2019 Category: Medical Devices Authors: ( at NIMHD) Source Type: news

Today is #NationalBikiniDay and the @US_FDA encourages you to use proper skin care while out in the sun. Check out the FDA ’ s information on tanning: https://go.usa.gov/xyYd3   pic.twitter.com/c3VZg1rgv0
Today is #NationalBikiniDay and the @US_FDA encourages you to use proper skin care while out in the sun. Check out the FDA’s information on tanning: https://go.usa.gov/xyYd3  pic.twitter.com/c3VZg1rgv0 (Source: Food and Drug Adminstration (FDA): CDRHNew)
Source: Food and Drug Adminstration (FDA): CDRHNew - July 5, 2019 Category: Medical Devices Authors: ( at FDADeviceInfo) Source Type: news

Congrats to our very own Bakul Patel! https://twitter.com/_bakulpatel/status/1146437211790958593   …
Congrats to our very own Bakul Patel! https://twitter.com/_bakulpatel/status/1146437211790958593 … (Source: Food and Drug Adminstration (FDA): CDRHNew)
Source: Food and Drug Adminstration (FDA): CDRHNew - July 3, 2019 Category: Medical Devices Authors: ( at FDADeviceInfo) Source Type: news

Check out the @US_FDA ’ s tips for healthy vacationing before heading out for some fun in the sun with family and friends: https://go.usa.gov/xy2WS   pic.twitter.com/egZvfxSDAb
Check out the @US_FDA’s tips for healthy vacationing before heading out for some fun in the sun with family and friends: https://go.usa.gov/xy2WS  pic.twitter.com/egZvfxSDAb (Source: Food and Drug Adminstration (FDA): CDRHNew)
Source: Food and Drug Adminstration (FDA): CDRHNew - July 3, 2019 Category: Medical Devices Authors: ( at FDADeviceInfo) Source Type: news

Recommendations provided during the meeting will address which factors the #FDA and medical device industry should consider when communicating cybersecurity risks to patients and to the public #PEAC #MedicalDevicepic.twitter.com/WGD0npQdHB
Recommendations provided during the meeting will address which factors the #FDA and medical device industry should consider when communicating cybersecurity risks to patients and to the public #PEAC #MedicalDevice pic.twitter.com/WGD0npQdHB (Source: Food and Drug Adminstration (FDA): CDRHNew)
Source: Food and Drug Adminstration (FDA): CDRHNew - July 2, 2019 Category: Medical Devices Authors: ( at FDADeviceInfo) Source Type: news

Join @US_FDA on Sept 10, 2019 for a meeting of the Patient Engagement Advisory Committee. During the meeting the committee will discuss and make recommendations on the topic “ Cybersecurity in Medical Devices: Communication That Empowers Patients. ” #PEAC https://go.usa.gov/xy2JK  
Join @US_FDA on Sept 10, 2019 for a meeting of the Patient Engagement Advisory Committee. During the meeting the committee will discuss and make recommendations on the topic “Cybersecurity in Medical Devices: Communication That Empowers Patients.” #PEAC https://go.usa.gov/xy2JK  (Source: Food and Drug Adminstration (FDA): CDRHNew)
Source: Food and Drug Adminstration (FDA): CDRHNew - July 2, 2019 Category: Medical Devices Authors: ( at FDADeviceInfo) Source Type: news

On June 11th, the @US_FDA identified a Class I Recall, the most serious type of recall: Edwards Lifesciences Recalls the IntraClude Intra-Aortic Occlusion Device Due to Risk of Balloon Rupture. Find out more are the recall: https://go.usa.gov/xy2tB   #FDA #MedicalDevicepic.twitter.com/2MwDtK3046
On June 11th, the @US_FDA identified a Class I Recall, the most serious type of recall: Edwards Lifesciences Recalls the IntraClude Intra-Aortic Occlusion Device Due to Risk of Balloon Rupture. Find out more are the recall: https://go.usa.gov/xy2tB  #FDA #MedicalDevice pic.twitter.com/2MwDtK3046 (Source: Food and Drug Adminstration (FDA): CDRHNew)
Source: Food and Drug Adminstration (FDA): CDRHNew - July 2, 2019 Category: Medical Devices Authors: ( at FDADeviceInfo) Source Type: news

On June 24th, the @US_FDA identified a Class I Recall, the most serious type of recall: Becton Dickinson & Company (BD) Recalls SmartSite Syringe Administration Set Due to Risk of Leaks. Find out more are the recall: https://go.usa.gov/xy25r   #FDA #MedicalDevicepic.twitter.com/2zmnKBYEq7
On June 24th, the @US_FDA identified a Class I Recall, the most serious type of recall: Becton Dickinson & Company (BD) Recalls SmartSite Syringe Administration Set Due to Risk of Leaks. Find out more are the recall: https://go.usa.gov/xy25r  #FDA #MedicalDevice pic.twitter.com/2zmnKBYEq7 (Source: Food and Drug Adminstration (FDA): CDRHNew)
Source: Food and Drug Adminstration (FDA): CDRHNew - July 1, 2019 Category: Medical Devices Authors: ( at FDADeviceInfo) Source Type: news

Happy #SocialMediaDay!pic.twitter.com/YXcqzyZRqe
Happy #SocialMediaDay! pic.twitter.com/YXcqzyZRqe (Source: Food and Drug Adminstration (FDA): CDRHNew)
Source: Food and Drug Adminstration (FDA): CDRHNew - June 30, 2019 Category: Medical Devices Authors: ( at FDADeviceInfo) Source Type: news

On June 27th the @US_FDA identified a Class I Recall, the most serious type of recall: Vyaire Medical recalls the enFlow Fluid Warming System Disposable Cartridges due to potential risk of exposure to elevated levels of aluminum exposure to patients: https://go.usa.gov/xygRd   pic.twitter.com/iUTS404QVg
On June 27th the @US_FDA identified a Class I Recall, the most serious type of recall: Vyaire Medical recalls the enFlow Fluid Warming System Disposable Cartridges due to potential risk of exposure to elevated levels of aluminum exposure to patients: https://go.usa.gov/xygRd  pic.twitter.com/iUTS404QVg (Source: Food and Drug Adminstration (FDA): CDRHNew)
Source: Food and Drug Adminstration (FDA): CDRHNew - June 28, 2019 Category: Medical Devices Authors: ( at FDADeviceInfo) Source Type: news

Today @US_FDA issued a FDA Safety Communication on certain Medtronic MiniMed insulin pumps and their potential #Cybersecurity risks. Find out more: https://go.usa.gov/xyYHF   #FDA #MedicalDevicepic.twitter.com/ddTHFLxCr7
Today @US_FDA issued a FDA Safety Communication on certain Medtronic MiniMed insulin pumps and their potential #Cybersecurity risks. Find out more: https://go.usa.gov/xyYHF  #FDA #MedicalDevice pic.twitter.com/ddTHFLxCr7 (Source: Food and Drug Adminstration (FDA): CDRHNew)
Source: Food and Drug Adminstration (FDA): CDRHNew - June 27, 2019 Category: Medical Devices Authors: ( at FDADeviceInfo) Source Type: news

Federal stakeholders will listen to the session participants explore solutions that promote a shared future vision of next generation, interoperable, and intelligent health systems.
(Source: Food and Drug Adminstration (FDA): CDRHNew)
Source: Food and Drug Adminstration (FDA): CDRHNew - June 27, 2019 Category: Medical Devices Authors: ( at FDADeviceInfo) Source Type: news

The feedback received from the listening session will provide potential research directions for advancing medical device interoperability.
(Source: Food and Drug Adminstration (FDA): CDRHNew)
Source: Food and Drug Adminstration (FDA): CDRHNew - June 27, 2019 Category: Medical Devices Authors: ( at FDADeviceInfo) Source Type: news

Join @US_FDA and others from @NITRDgov at #FDA ’ s White Oak Campus on July 17th for a listening session on the interoperability of #MedicalDevice, data and platforms: https://go.usa.gov/xyr3A  
Join @US_FDA and others from @NITRDgov at #FDA’s White Oak Campus on July 17th for a listening session on the interoperability of #MedicalDevice, data and platforms: https://go.usa.gov/xyr3A  (Source: Food and Drug Adminstration (FDA): CDRHNew)
Source: Food and Drug Adminstration (FDA): CDRHNew - June 27, 2019 Category: Medical Devices Authors: ( at FDADeviceInfo) Source Type: news

Ultrasound is an established imaging modality with a long history of safe use. Today, the @US_FDA issued the final guidance, Marketing Clearance of Diagnostic Ultrasound Systems and Transducers. https://go.usa.gov/xyrfT   pic.twitter.com/sGzqOoPIui
Ultrasound is an established imaging modality with a long history of safe use. Today, the @US_FDA issued the final guidance, Marketing Clearance of Diagnostic Ultrasound Systems and Transducers. https://go.usa.gov/xyrfT  pic.twitter.com/sGzqOoPIui (Source: Food and Drug Adminstration (FDA): CDRHNew)
Source: Food and Drug Adminstration (FDA): CDRHNew - June 26, 2019 Category: Medical Devices Authors: ( at FDADeviceInfo) Source Type: news

This final guidance provides FDA ’ s detailed recommendations for manufacturers seeking marketing clearance of diagnostic ultrasound systems and transducers. #FDA #MedicalDevice
This final guidance provides FDA’s detailed recommendations for manufacturers seeking marketing clearance of diagnostic ultrasound systems and transducers. #FDA #MedicalDevice (Source: Food and Drug Adminstration (FDA): CDRHNew)
Source: Food and Drug Adminstration (FDA): CDRHNew - June 26, 2019 Category: Medical Devices Authors: ( at FDADeviceInfo) Source Type: news

Thank you for all of your hard work, Richard! https://twitter.com/FDACommissioner/status/1143611127999471616   …
Thank you for all of your hard work, Richard! https://twitter.com/FDACommissioner/status/1143611127999471616 … (Source: Food and Drug Adminstration (FDA): CDRHNew)
Source: Food and Drug Adminstration (FDA): CDRHNew - June 26, 2019 Category: Medical Devices Authors: ( at FDADeviceInfo) Source Type: news

Today, @US_FDA issued a draft guidance, “ Clinical Investigations for Prostate Tissue Ablation Devices ” on how to comply with the clinical testing special control required for 510(k)s and how to collect clinical data to support other marketing submissions: https://go.usa.gov/xyCJC   pic.twitter.com/m4TKb8ikxJ
Today, @US_FDA issued a draft guidance, “Clinical Investigations for Prostate Tissue Ablation Devices” on how to comply with the clinical testing special control required for 510(k)s and how to collect clinical data to support other marketing submissions: https://go.usa.gov/xyCJC  pic.twitter.com/m4TKb8ikxJ (Source: Food and Drug Adminstration (FDA): CDRHNew)
Source: Food and Drug Adminstration (FDA): CDRHNew - June 25, 2019 Category: Medical Devices Authors: ( at FDADeviceInfo) Source Type: news

Prostate tissue ablation devices currently on the market use high intensity ultrasound to ablate (destroy) prostate tissue, but these devices may also use other forms of energy. #FDA #MedicalDevice
(Source: Food and Drug Adminstration (FDA): CDRHNew)
Source: Food and Drug Adminstration (FDA): CDRHNew - June 25, 2019 Category: Medical Devices Authors: ( at FDADeviceInfo) Source Type: news

In our effort to make information available to the public, Alternative Summary Reports manufacturers reported to the FDA are now available on our website. https://go.usa.gov/xyxwP   #medicaldevice #safety
In our effort to make information available to the public, Alternative Summary Reports manufacturers reported to the FDA are now available on our website. https://go.usa.gov/xyxwP  #medicaldevice #safety (Source: Food and Drug Adminstration (FDA): CDRHNew)
Source: Food and Drug Adminstration (FDA): CDRHNew - June 21, 2019 Category: Medical Devices Authors: ( at FDADeviceInfo) Source Type: news

Teleflex Medical Recalls the Hudson RCI Sheridan and Sheridan Endotracheal Tubes Due to Risk of the Sheridan Connector Disconnecting from the Breathing Circuit https://go.usa.gov/xyxmD   #medicaldevice
Teleflex Medical Recalls the Hudson RCI Sheridan and Sheridan Endotracheal Tubes Due to Risk of the Sheridan Connector Disconnecting from the Breathing Circuit https://go.usa.gov/xyxmD  #medicaldevice (Source: Food and Drug Adminstration (FDA): CDRHNew)
Source: Food and Drug Adminstration (FDA): CDRHNew - June 21, 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: Cook Incorporated Recalls Advance Enforcer 35 Focal Force PTA Balloon Catheter Due to Balloons Bursting Below the Rated Burst Pressure. Find out more: https://go.usa.gov/xy3K7   #MedicalDevicepic.twitter.com/nMub6nAmDt
Today, the @US_FDA identified a Class I Recall, the most serious type of recall: Cook Incorporated Recalls Advance Enforcer 35 Focal Force PTA Balloon Catheter Due to Balloons Bursting Below the Rated Burst Pressure. Find out more: https://go.usa.gov/xy3K7  #MedicalDevice pic.twitter.com/nMub6nAmDt (Source: Food and Drug Adminstration (FDA): CDRHNew)
Source: Food and Drug Adminstration (FDA): CDRHNew - June 18, 2019 Category: Medical Devices Authors: ( at FDADeviceInfo) Source Type: news

Happening now! Organizations who have partnered with CDRH ’ s newly established Patient & Caregiver Connection are on campus today. These organizations represent at least one of the conditions diagnosed, treated, or managed with devices regulated by CDRH. #MedicalDevicepic.twitter.com/Wk50IraR8v
Happening now! Organizations who have partnered with CDRH’s newly established Patient & Caregiver Connection are on campus today. These organizations represent at least one of the conditions diagnosed, treated, or managed with devices regulated by CDRH. #MedicalDevice pic.twitter.com/Wk50IraR8v (Source: Food and Drug Adminstration (FDA): CDRHNew)
Source: Food and Drug Adminstration (FDA): CDRHNew - June 18, 2019 Category: Medical Devices Authors: ( at FDADeviceInfo) Source Type: news

Happy #NationalFlipFlopDay! https://twitter.com/US_FDA/status/1139578243735019520   …
Happy #NationalFlipFlopDay! https://twitter.com/US_FDA/status/1139578243735019520 … (Source: Food and Drug Adminstration (FDA): CDRHNew)
Source: Food and Drug Adminstration (FDA): CDRHNew - June 14, 2019 Category: Medical Devices Authors: ( at FDADeviceInfo) Source Type: news

The mouse embryo assay is a commonly used test to assess whether an assisted reproduction technology device, such as in vitro fertilization, has a toxic effect on human embryos.
(Source: Food and Drug Adminstration (FDA): CDRHNew)
Source: Food and Drug Adminstration (FDA): CDRHNew - June 12, 2019 Category: Medical Devices Authors: ( at FDADeviceInfo) Source Type: news

The @US_FDA encourages readers of the draft guidance to submit comments related to the draft guidance to the open docket through August 12, 2019: https://go.usa.gov/xmJ5s   #MedicalDevice
The @US_FDA encourages readers of the draft guidance to submit comments related to the draft guidance to the open docket through August 12, 2019: https://go.usa.gov/xmJ5s  #MedicalDevice (Source: Food and Drug Adminstration (FDA): CDRHNew)
Source: Food and Drug Adminstration (FDA): CDRHNew - June 12, 2019 Category: Medical Devices Authors: ( at FDADeviceInfo) Source Type: news

Today, the @US_FDA issued a new draft guidance that includes proposed recommendations on how to perform the mouse embryo assay. https://go.usa.gov/xmJ5w   pic.twitter.com/8ii1j2c8vR
Today, the @US_FDA issued a new draft guidance that includes proposed recommendations on how to perform the mouse embryo assay. https://go.usa.gov/xmJ5w  pic.twitter.com/8ii1j2c8vR (Source: Food and Drug Adminstration (FDA): CDRHNew)
Source: Food and Drug Adminstration (FDA): CDRHNew - June 12, 2019 Category: Medical Devices Authors: ( at FDADeviceInfo) Source Type: news

Got pathogens? @US_FDA is searching for microbes including biothreat organisms, emerging pathogens, and clinically significant bacterial, viral, fungal, and parasitic genomes. Contribute samples to FDA for free sequencing and analysis. https://argos.igs.umaryland.edu/   pic.twitter.com/YBIZCD9lhf
Got pathogens? @US_FDA is searching for microbes including biothreat organisms, emerging pathogens, and clinically significant bacterial, viral, fungal, and parasitic genomes. Contribute samples to FDA for free sequencing and analysis. https://argos.igs.umaryland.edu/  pic.twitter.com/YBIZCD9lhf (Source: Food and Drug Adminstration (FDA): CDRHNew)
Source: Food and Drug Adminstration (FDA): CDRHNew - June 12, 2019 Category: Medical Devices Authors: ( at FDA_MCMi) Source Type: news

When was the last time you called your doctor? Today is #NationalCallYourDoctorDay and the @US_FDA is encouraging women to schedule their annual Well-Woman Exam to help stay healthy.pic.twitter.com/6GWU4JtA40
When was the last time you called your doctor? Today is #NationalCallYourDoctorDay and the @US_FDA is encouraging women to schedule their annual Well-Woman Exam to help stay healthy. pic.twitter.com/6GWU4JtA40 (Source: Food and Drug Adminstration (FDA): CDRHNew)
Source: Food and Drug Adminstration (FDA): CDRHNew - June 11, 2019 Category: Medical Devices Authors: ( at FDADeviceInfo) Source Type: news

You don ’ t have to bury it in the sand but try to keep your sunscreen out of direct to keep it in good condition. You can wrap it in a towel, keep it under shade or even store it in the cooler if you ’ re outside in the heat for a long time. https://go.usa.gov/xUYCd   pic.twitter.com/QnbziIYQ9t
You don’t have to bury it in the sand but try to keep your sunscreen out of direct to keep it in good condition. You can wrap it in a towel, keep it under shade or even store it in the cooler if you’re outside in the heat for a long time. https://go.usa.gov/xUYCd  pic.twitter.com/QnbziIYQ9t (Source: Food and Drug Adminstration (FDA): CDRHNew)
Source: Food and Drug Adminstration (FDA): CDRHNew - June 11, 2019 Category: Medical Devices Authors: ( at US_FDA) Source Type: news

June is #MensHealthMonth and the @US_FDA encourages men and boys to choose healthy food options, visit their doctor for routine check ups and screenings, and exercise regularly.pic.twitter.com/NnVwUgu1jp
June is #MensHealthMonth and the @US_FDA encourages men and boys to choose healthy food options, visit their doctor for routine check ups and screenings, and exercise regularly. pic.twitter.com/NnVwUgu1jp (Source: Food and Drug Adminstration (FDA): CDRHNew)
Source: Food and Drug Adminstration (FDA): CDRHNew - June 10, 2019 Category: Medical Devices Authors: ( at FDADeviceInfo) Source Type: news

REMINDER: On June 11, 2019 from 3-4:30 p.m EST, the @US_FDA will host a webinar on the Q-Submission Program for Medical Device Submissions. Registration is not necessary. Find out more about the upcoming webinar: https://go.usa.gov/xmtGy   #FDA #MedicalDevicepic.twitter.com/AKog2SDNNC
REMINDER: On June 11, 2019 from 3-4:30 p.m EST, the @US_FDA will host a webinar on the Q-Submission Program for Medical Device Submissions. Registration is not necessary. Find out more about the upcoming webinar: https://go.usa.gov/xmtGy  #FDA #MedicalDevice pic.twitter.com/AKog2SDNNC (Source: Food and Drug Adminstration (FDA): CDRHNew)
Source: Food and Drug Adminstration (FDA): CDRHNew - June 10, 2019 Category: Medical Devices Authors: ( at FDADeviceInfo) Source Type: news

#DYK? https://twitter.com/US_FDA/status/1137071731825229824   …
#DYK? https://twitter.com/US_FDA/status/1137071731825229824 … (Source: Food and Drug Adminstration (FDA): CDRHNew)
Source: Food and Drug Adminstration (FDA): CDRHNew - June 7, 2019 Category: Medical Devices Authors: ( at FDADeviceInfo) Source Type: news

Today is #NationalEyeWearDay! Check out the @US_FDA's useful tips for everyday eye care: https://go.usa.gov/xmeZ5   pic.twitter.com/KXds3eQSCe
Today is #NationalEyeWearDay! Check out the @US_FDA's useful tips for everyday eye care: https://go.usa.gov/xmeZ5  pic.twitter.com/KXds3eQSCe (Source: Food and Drug Adminstration (FDA): CDRHNew)
Source: Food and Drug Adminstration (FDA): CDRHNew - June 6, 2019 Category: Medical Devices Authors: ( at FDADeviceInfo) Source Type: news

Yesterday @NESTccMedTech announced selection of 12 new test cases, including an #FDA submitted study on using real-world data to better understand the device safety profile of mesh used for stress urinary incontinence: https://www.businesswire.com/news/home/20190604006034/en/National-Evaluation-System-health-Technology-Coordinating-Center   …
Yesterday @NESTccMedTech announced selection of 12 new test cases, including an #FDA submitted study on using real-world data to better understand the device safety profile of mesh used for stress urinary incontinence: https://www.businesswire.com/news/home/20190604006034/en/National-Evaluation-System-health-Technology-Coordinating-Center … (Source: Food and Drug Adminstration (FDA): CDRHNew)
Source: Food and Drug Adminstration (FDA): CDRHNew - June 5, 2019 Category: Medical Devices Authors: ( at FDADeviceInfo) Source Type: news

Over the next year, the test case will explore if long-term real-world data from electronic health records can provide information to further the @US_FDA ’ s understanding of adverse events associated with use of this device. #MedicalDevicepic.twitter.com/KvUJM9fpN1
Over the next year, the test case will explore if long-term real-world data from electronic health records can provide information to further the @US_FDA’s understanding of adverse events associated with use of this device. #MedicalDevice pic.twitter.com/KvUJM9fpN1 (Source: Food and Drug Adminstration (FDA): CDRHNew)
Source: Food and Drug Adminstration (FDA): CDRHNew - June 5, 2019 Category: Medical Devices Authors: ( at FDADeviceInfo) Source Type: news

#DYK https://twitter.com/FDAfood/status/1134102877566316544   …
#DYK https://twitter.com/FDAfood/status/1134102877566316544 … (Source: Food and Drug Adminstration (FDA): CDRHNew)
Source: Food and Drug Adminstration (FDA): CDRHNew - June 4, 2019 Category: Medical Devices Authors: ( at FDADeviceInfo) Source Type: news

On May 30th, the @US_FDA identified a Class I Recall, the most serious type of recall: Terumo Medical Corporation Recalls SOLOPATH ® Balloon Expandable TransFemoral System and Re-Collapsible Balloon Access System: https://go.usa.gov/xmH6g   pic.twitter.com/vEMrDEvLUW
On May 30th, the @US_FDA identified a Class I Recall, the most serious type of recall: Terumo Medical Corporation Recalls SOLOPATH® Balloon Expandable TransFemoral System and Re-Collapsible Balloon Access System: https://go.usa.gov/xmH6g  pic.twitter.com/vEMrDEvLUW (Source: Food and Drug Adminstration (FDA): CDRHNew)
Source: Food and Drug Adminstration (FDA): CDRHNew - May 31, 2019 Category: Medical Devices Authors: ( at FDADeviceInfo) Source Type: news