Moving Towards A Total Lifecycle Regulatory Approach For AI Devices

PCCPs On FDA And Global Agenda For 2024

10 Jun 2024

Proportionately regulating highly adaptive AI as a medical device can be done with predetermined change control plans. The US, UK and Canada are advancing the concept, as Ropes & Gray and the US FDA explained.

Artificial intelligence (agsandrew/Shutterstock.com)

Device and healthtech innovation is prone to getting ahead of regulation. The arrival of artificial intelligence as a medical device (AIaMD) is testing processing capacities to the limit, which is where pre-determined change control plans (PCCP) can serve a useful purpose.

AI/machine learning technological advances will continue to challenge regulatory systems around the world, Ropes & Gray’s Lincoln Tsang believes.

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