Tag: Center for Devices and Radiological Health

All

How CDRH’s Digital Transformation Initiative Will Strengthen the Premarket Review Program

Through its Digital Transformation Initiative, the U.S. FDA’s Center for Devices and Radiological Health aims to build a more robust, digital infrastructure to optimize the premarket review program for medical devices.

Sensome AI-Powered Stroke Guidewire Gets FDA Breakthrough Device Designation
Ransomware, Other Cyber Threats Mount as Medtech Industry Tries to Adapt
FDA Continues to Monitor Effects of Magnets in Consumer Electronics on Implanted Medical Devices
Leveraging Real World Evidence in Regulatory Submissions of Medical Devices
Elastomeric Respirator Innovations Play a Critical Role in Response to COVID-19
FDA to Participate in MDIC Case for Quality Collaborative Community

All

FDA’s Medical Device Arm Responds to COVID-19 with “Unprecedented” Efforts

The FDA’s Stephen M. Hahn details how the CDRH has ramped up its medical device regulatory and authorization efforts in response to COVID-19.

Center for Devices and Radiological Health Pledges Support of Open Sharing Data
FDA Updating Medical Device Reporting Program
FDA Addresses Tracheostomy Tube Shortage Following Sterilization Facility Closures

All

Sorry, No Posts Found

All

How CDRH’s Digital Transformation Initiative Will Strengthen the Premarket Review Program

Sensome AI-Powered Stroke Guidewire Gets FDA Breakthrough Device Designation
Ransomware, Other Cyber Threats Mount as Medtech Industry Tries to Adapt
FDA Continues to Monitor Effects of Magnets in Consumer Electronics on Implanted Medical Devices
Leveraging Real World Evidence in Regulatory Submissions of Medical Devices
Elastomeric Respirator Innovations Play a Critical Role in Response to COVID-19
FDA to Participate in MDIC Case for Quality Collaborative Community

Tag: Center for Devices and Radiological Health

All

How CDRH’s Digital Transformation Initiative Will Strengthen the Premarket Review Program

Sensome AI-Powered Stroke Guidewire Gets FDA Breakthrough Device Designation

Ransomware, Other Cyber Threats Mount as Medtech Industry Tries to Adapt

FDA Continues to Monitor Effects of Magnets in Consumer Electronics on Implanted Medical Devices

Leveraging Real World Evidence in Regulatory Submissions of Medical Devices

Elastomeric Respirator Innovations Play a Critical Role in Response to COVID-19

FDA to Participate in MDIC Case for Quality Collaborative Community

All

FDA’s Medical Device Arm Responds to COVID-19 with “Unprecedented” Efforts

Center for Devices and Radiological Health Pledges Support of Open Sharing Data

FDA Updating Medical Device Reporting Program

FDA Addresses Tracheostomy Tube Shortage Following Sterilization Facility Closures

All

Sorry, No Posts Found

All

How CDRH’s Digital Transformation Initiative Will Strengthen the Premarket Review Program

Sensome AI-Powered Stroke Guidewire Gets FDA Breakthrough Device Designation

Ransomware, Other Cyber Threats Mount as Medtech Industry Tries to Adapt

FDA Continues to Monitor Effects of Magnets in Consumer Electronics on Implanted Medical Devices

Leveraging Real World Evidence in Regulatory Submissions of Medical Devices

Elastomeric Respirator Innovations Play a Critical Role in Response to COVID-19

FDA to Participate in MDIC Case for Quality Collaborative Community

Sorry, No Posts Found

All

Sorry, No Posts Found

24×7

Our Parent Company

Key Resources

Helpful Links