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Postmarket Surveillance Continues To Challenge AI/ML Device Regulators

 
• By Hannah Daniel

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

• Source: Shutterstock

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 Excellence (DHCoE), about AI and ML integration into the agency’s...

Key Takeaways

  • Postmarket surveillance of AI/ML devices remains a regulatory issue.

  • The FDA has seen more AI/ML devices beyond radiology applications....

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