Regulatory Hurdles and Ethical Concerns in FDA Oversight of AI/ML Medical Devices

Pharmacy Times October 15, 2024
Alana Hippensteele, Managing Editor

Key Takeaways

• The FDA struggles with regulating AI/ML devices, often underestimating their prevalence and impact in medical devices.
• Continuous glucose monitors, despite AI/ML integration, follow traditional approval pathways, bypassing AI-specific scrutiny.
• Ethical concerns arise from AI biases, as studies reveal racial and gender disparities in medical diagnoses.
• Many AI/ML devices lack transparency and validation, posing challenges for regulatory oversight and public trust.

The FDA faces a multitude of challenges in regulating artificial intelligence (AI) and machine learning (ML) medical devices.

There are a lot of parallels with how the FDA manages the review of devices and drugs, explained Omar Badawi, PharmD, MPH, FCCM, during a presentation at the 2024 American College of Clinical Pharmacy (ACCP) Annual Meeting. However,...

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