Postmarket Surveillance Continues To Challenge AI/ML Device Regulators

Postmarket surveillance of AI/ML is a continuing issue for regulation, DHCoE acting assistant director MiRa Jacobs says.

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The US Food and Drug Administration has not had enough time to monitor artificial intelligence (AI) and machine learning (ML) devices after approval or clearance, hindering the agency’s ability to regulate those devices.

The Alliance for a Stronger FDA spoke to MiRa Jacobs, the acting assistant director of the Digital Health Center of...

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