The Food and Drug Administration (FDA) has announced the release of draft guidance for outlining a set of modifications that a developer can include as part of a submission. Medical algorithms are typically “locked”, not changing after receiving FDA clearance, the new guidance would allow for some predetermined modifications.
The guidance, “Marketing Submission Recommendations for a Predetermined Change Control Plan for Artificial Intelligence/Machine Learning-Enabled Device Software Functions”, is intended to allow AI/ML-enabled software to be safely, effectively and quickly updated in response to new data.
The FDA outlined what elements developers should include as part of these plans including, a description of the planned modifications, an explanation of the methodology for validation and implementation, and a benefits and risk assessment. Furthermore, companies will need to provide details on how they will clearly communicate any modifications to users.
The guidance is aiming to facilitate the rapid improvement of AI/ML-enabled device performance across populations, however, there will be an increased burden on developers, owing to the volume of documentation and administration required.
"The approach the FDA is proposing in this draft guidance would put safe and effective advancements in the hands of healthcare providers and users faster, increasing the pace of medical device innovation in the United States and enabling more personalized medicine," said Brendan O'Leary, deputy director of the Digital Health Center of Excellence in the FDA's Center for Devices and Radiological Health.
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