Director – Office of Strategic Partnerships & Technology Innovation (OST) at CDRH US FDA
Key global markets, including U.S., Australia, Canada, France, and the European Union, have specific guidance for medical device cybersecurity. FDA continues to raise the bar on industry expectations for medical devices. More widely in the US, the recent passage of the Omnibus Act has introduced new regulations that will be in effect in March 2023 for any new submission. In addition, the International Medical Device Regulators Forum (IMDRF) released a detailed guidance on Medical Device Cybersecurity. The quantity of new expectations calls for a strategy to ensure that medical device manufacturers will be prepared to enter their preferred market without costly delays. Cybersecurity is an area where regulatory, quality, and engineering teams need to work closely together to ensure that their products are secure and this starts with a solid understanding of what the regulators will be expecting. Hear from two leaders with executive experience, one from the US FDA and one who has spent over a decade guiding the medical device industry on cybersecurity best practices.
Learning Objectives:
Upon completion, participants will be able to interpret each FDA cybersecurity guidance and drivers for new expectations in recent draft premarket cybersecurity guidance
Upon completion, participants will be able to list the new expectations originating from the Omnibus Act and how this should inform their next submission
Upon completion, participants will be able to identify unique global cybersecurity expectations that differ from the US to ensure that they guide their teams to successbutl global submissions
.jpeg "Michelle Lynn Jump, MS, MSRS, ISO/TC 215 convener, RAPS instructor photo")
