Medical Design Briefs - February 2021 - 2

FROM

THE EDITOR

A Look at FDA's Plan for Artificial
Intelligence and Machine Learning
in Medical Devices

DA just released the agency's first
action plan addressing artificial intelligence (AI) and machine learning
(ML): Artificial Intelligence/Machine
Learning (AI/ML)-Based Software as a
Medical Device (SaMD) Action Plan.
The plan describes a multi-pronged

approach to advance the agency's oversight of AI/ML-based medical software.
The data from AI has great potential to
transform healthcare by providing insights
and enabling more personalized medicine. FDA wants to ensure that such software is safe and effective and will improve
the quality of care that patients receive.
" This action plan outlines the FDA's
next steps towards furthering oversight
for AI/ML-based SaMD, " says Bakul

Patel, director of the Digital Health
Center of Excellence in the Center for
Devices and Radiological Health
(CDRH). " The plan outlines a holistic
approach based on total product lifecycle oversight to further the enormous
potential that these technologies have to
improve patient care while delivering
safe and effective software functionality
that improves the quality of care that
patients receive. To stay current and
address patient safety and improve
access to these promising technologies,
we anticipate that this action plan will
continue to evolve over time. "
The plan outlines five actions that
FDA intends to take, including:
* Further developing the proposed regulatory framework, including through
issuance of draft guidance on a predetermined change control plan (for
software's learning over time).
* Supporting the development of good
machine learning practices to evaluate
and improve machine learning algorithms.
* Fostering a patient-centered approach,
including device transparency to users.
* Developing methods to evaluate and
improve machine learning algorithms.
* Advancing real-world performance
monitoring pilots.
The plan is a response to stakeholder
feedback received from a discussion
paper published in April 2019. FDA says
it welcomes continued feedback and will
continue to build a coordinated approach in areas of common focus related to AI/ML.
AI/ML-based devices have unique
considerations that necessitate a proactive patient-centered approach to their
development and utilization that takes
into account issues including usability,
equity, trust, and accountability, says
FDA. One way that the agency is addressing these issues is through the promotion of the transparency of these devices
to users, and to patients more broadly,
about the devices' functioning. FDA
emphasizes the need for manufacturer's
to be transparent about the functioning
of AI/ML-based devices to ensure that
users understand the benefits, risks, and
limitations of these devices.
Sherrie Trigg
Editor and Director of Medical Content
To download a copy of the plan, go to
www.fda.gov/media/145022/download.

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Medical Design Briefs, February 2021

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Medical Design Briefs - February 2021

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