Regulatory
It’s fi nally here: the FDA’s action plan for regulating medical devices employing AI/ML. Monica Karpinski investigates the key legal, practical and ethical challenges the FDA needs to address, asking what the eventual regulations may look like and how manufacturers can use them to improve the way they work with AI devices.
n October 2014, Elon Musk famously likened
the use of AI to summoning a demon. He was no doubt referring to the existential threat of using technology that is unknowable: if it changes in ways
n October 2014, Elon Musk famously likened the use of AI to summoning a demon. He was no doubt referring to the existential threat of using
technology that is unknowable: if it changes in ways that we can’t predict, how can we hope to control
Now, regulators are asking themselves the same questions. Recent years have seen global
In January 2021, the FDA released an action plan describing how they mean to establish a
In January 2021, the FDA released an action
plan describing how they mean to establish a regulatory framework for medical devices that
that we can’t predict, how can we hope to control it? How can we guarantee that it will be safe to use?it? How can we guarantee that it will be safe to use? Now, regulators are asking themselves the
same questions. Recent years have seen global recommendations put in place for regulating AI, but
recommendations put in place for regulating AI, but it is very much an emerging field – many agenciesit is very much an emerging field – many agencies are still in the research phase of developing clear and defined guidelines.
are still in the research phase of developing clear and defined guidelines.
regulatory framework for medical devices that use AI. While this is an exciting step forward, s only the beginning of the journey. The
use AI. While this is an exciting step forward, it’it’s only the beginning of the journey. The plan should be understood as a statement of
Affirmative action I
plan should be understood as a statement of intentions – a road map towards an enforceableintentions – a road map towards an enforceable set of rules. As such, the plan explains how the
set of rules. As such, the plan explains how the agency will proceed with investigating five key
agency will proceed with investigating five key areas relating to software as a medical device
areas relating to software as a medical device (SaMD): creating a regulatory framework for
(SaMD): creating a regulatory framework for devices that change over time, establishing best
devices that change over time, establishing best practices in AI/ML, fostering a patient-centred
practices in AI/ML, fostering a patient-centred approach, managing algorithmic bias and
approach, managing algorithmic bias and robustness, and monitoring real-world performance
Regulatory Framework for Modifications to Artificial Intelligence/Machine Learning-Based
Artificial Intelligence/Machine Learning-Based Software as a Medical Device’.
robustness, and monitoring real-world performance of devices. It is informed by stakeholder feedback
of devices. It is informed by stakeholder feedback on a 2019 FDA discussion paper entitled, ‘Proposed
Software as a Medical Device’. The work that has already been done to assess
some clues on how the action plan is likely to be used and refined. By considering how the legal,
used and refined. By considering how the legal, ethical and practical challenges identified could
on a 2019 FDA discussion paper entitled, ‘Proposed Regulatory Framework for Modifications to
The work that has already been done to assess and regulate the use of AI in medical devices gives
and regulate the use of AI in medical devices gives some clues on how the action plan is likely to be
ethical and practical challenges identified could realistically be addressed, it’s possible to get a sense of what the eventual regulations will look like.
realistically be addressed, it’s possible to get a sense of what the eventual regulations will look like.
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Medical Device Developments /
www.nsmedicaldevices.com
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