MedTech DiveFDA Prioritizes Guidance on AI, Cybersecurity, Pulse Oximeters in Stacked Schedule for 2024

The administration is ramping up production of medtech guidance, adding 18 draft documents to the list of priorities for the upcoming financial year.

In a proactive move, the Food and Drug Administration (FDA) has unveiled an ambitious plan for its 2024 agenda, prioritizing 18 draft documents focused on critical areas such as artificial intelligence, cybersecurity, real-world evidence, and pulse oximeters. Looking at the key points, it becomes evident that the FDA is keenly addressing the evolving landscape of medtech, with a specific focus on AI-enabled devices, cybersecurity protocols, and emergency use authorizations in response to crises.

Key Points:

• The FDA’s 2024 agenda includes 18 draft documents, a substantial increase from previous years, covering topics like AI, cybersecurity, real-world evidence, and pulse oximeters.
• AI and machine learning take center stage, with a focus on lifecycle management and premarket submissions for AI-enabled devices.
• Emergency use authorizations are a key concern, with three drafts outlining the FDA’s stance on rule enforcement during diagnostic responses to emerging outbreaks.
• Biocompatibility, sex- and gender-specific data in device trials, and conformity assessment accreditation scheme advice are highlighted in drafts promoted from the B-list.
• The A-list features crucial guidance on remanufacturing medical devices, addressing shortages, and offering advice on predetermined change control plans for AI and ML-enabled device software.

HCN Medical Memo
Did you know that by 2025, the global AI in healthcare market is projected to reach $34 billion, revolutionizing diagnostics, treatment plans, and patient care?

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