Welcome to our new website! If this is the first time you are logging in on the new site, you will need to reset your password. Please contact us at firstname.lastname@example.org if you need assistance.
Your membership opens the door to free learning resources on demand. Check out the Member Knowledge Center for free webcasts, publications and online courses.
The highly-anticipated fifth edition is here! Get the must-have resource for achieving compliance with medical device regulations.
Hear from leaders around the globe as they share insights about their experiences and lessons learned throughout their certification journey.
The US Food and Drug Administration's (FDA) Center for Devices and Radiological Health (CDRH) will look to better leverage big data and advance the use of patient-reported outcomes in regulatory decision making, according to a top 10 list of regulatory science priorities released on Tuesday.
The release of the list coincides with the overarching goal of CDRH regulatory science, which is to help develop and apply tools, standards and methodologies to study the safety, effectiveness, performance and quality of devices.
While serving as a way to help CDRH make strategic research funding decisions to ensure that the division's research is focused on the issues, gaps and needs relevant to the regulatory science of medical devices and radiation-emitting products, the list includes:
Safety has always been a top priority for CDRH, though the report notes that there is "a gap in the availability of tools and methodologies to assess the impact of various materials and material types on the quality, performance and safety of medical devices, particularly when trying to predict long-term clinical outcomes."
Among other things, CDRH will look to new methodologies and tools that more accurately predict the clinical impact of surface coatings, materials corrosion and additive manufacturing on device quality, performance and safety. In addition, CDRH will promote the development of alternative materials and look to increase the safety of the design of devices.
The center also calls for more research to understand how to enhance the performance and security of medical devices, and to understand the impact of software modifications on device performance.
The Regulatory Science Subcommittee (RSS) of the CDRH
CDRH explains that the list was created to help assess the needs and gaps in regulatory science and that it's intended to be proactive and anticipatory, while being responsive to emerging public health issues.
CDRH Regulatory Science Priorities Report
Tags: CDRH, FDA, regulatory science, device cybersecurity, device safety