USFDA Draft Guidance for AI-Enabled Medical Devices
The U.S. Food and Drug Administration (FDA) has released draft guidance aimed at supporting the development and marketing of safe and effective AI-enabled medical devices throughout their Total Product Life Cycle. Once finalized, this would be the first comprehensive guidance providing recommendations for every phase of AI-enabled device management, from design and development to maintenance and documentation. These guidelines are intended to help developers ensure the safety and effectiveness of such devices.
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This draft guidance complements the FDA’s recently issued final guidance on predetermined change control plans for AI-enabled devices, which outlines how to proactively manage device updates after they reach the market.
“The FDA has authorized more than 1,000 AI-enabled devices through established premarket pathways. As we witness exciting advancements in this field, it’s crucial to address the unique considerations of AI-enabled devices,” said Troy Tazbaz, director of the Digital Health Center of Excellence at the FDA’s Center for Devices and Radiological Health. “Today’s draft guidance consolidates key insights from previously authorized devices and serves as a valuable reference for developers, providing specific recommendations across the entire device life cycle—from initial development to post-market maintenance.”
Role of Operon Strategist
Operon Strategist plays a key role in helping developers align with FDA guidelines by providing:
- Regulatory Compliance: Tailored strategies for meeting FDA requirements.
- Documentation: Support for preparing design, risk, and maintenance documentation.
- Change Management: Expertise in creating plans for seamless post-market updates.
- Lifecycle Support: End-to-end guidance for device lifecycle management.
With expert solutions, Operon Strategist enables developers to confidently bring AI-enabled devices to market while ensuring regulatory compliance.
