We at Emergo by UL are proud to have had one of our senior consultants attend the MedCon Conference in Columbus, Ohio on April 24-26. Here we describe some of our top pre-market consideration takeaways from the conference for those who were unable to make it. We encourage all regulatory professionals to consider attending next year! But if you can’t, no worries. We will report all the medical device regulatory news you need to know.
Regulatory harmonization, convergence and reliance
While the primary regulatory agency in attendance was the U.S. FDA, representatives from Brazil’s ANVISA and EU Notified Body also attended. A significant push toward harmonization and regulatory reliance, driven by the International Medical Device Regulators Forum (IMDRF), was noted. While the details are still being worked out between regulators, the FDA recommended reviewing their draft strategic plan for international harmonization.
It was also noted how the U.S. FDA, Health Canada and the UK MHRA have collaborated to create guiding principles for good machine learning practices and predetermined change control plans (PCCPs).
Digital health
The topic of digital health, including but not limited to artificial intelligence and machine learning (AI/ML) was one of the running themes throughout the conference, and the FDA presented for many of these discussions. The FDA discussed their Digital Health Center of Excellence as providing significant guidance to the industry and discussed some of that guidance. Acknowledging that the information on digital health can be overwhelming, they highlighted their Digital Health Policy Navigator as a great starting point for those looking to understand what applies to their product. Particular emphasis was placed on supporting risk assessment through adequately addressed digital health, including considering using AAMI CR34971 for AI/ML and IMDRF N81. The FDA emphasized taking a total product lifecycle (TPLC) approach to digital devices. They also encouraged supporting safety through consideration of adequate patient perspectives for these devices.
Beyond the technological challenges, there was also discussion on how to appropriately label devices so that users and patients can obtain the data that they need without being overwhelmed with data that is unnecessary or might be confusing.
2024 MedCon Takeaways: Pre-Market Considerations | Emergo by UL
2024 MedCon Takeaways: Pre-Market Considerations
Here we describe our top pre-market consideration takeaways from the MedCon Conference in Columbus, Ohio on April 24-26 for those who were unable to attend.
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