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- FDA Releases Plans on Guidance for Responsible Use of AI for Medical Products
On March 14, the FDA Center for Biologics Evaluation and Research (CBER), Center for Drug Evaluation and Research (CDER), Center for Devices and Radiological Health (CDRH), and Office of Combination Products (OCP) jointly published a paper titled Artificial Intelligence & Medical Products: How CBER, CDER, CDRH, and OCP are Working Together.
These FDA centers plan to facilitate careful management of AI technologies throughout the product life cycle to help address ongoing model performance, risk management, and regulatory compliance of AI systems in real-world applications.
The centers are organizing their actions around four areas of focus regarding the uses of AI across the medical product life cycle:
- Foster collaboration to safeguard public health
- Advance the development of regulatory approaches that support innovation
- Promote the development of standards, guidelines, best practices, and tools for the medical product life cycle
- Support research related to the evaluation and monitoring of AI performance.
The FDA has noted that it will issue the following guidance for medical products:
- Final guidance on marketing submission recommendations for predetermined change control plans for AI-enabled device software functions.
- Draft guidance on life cycle management considerations and premarket submission recommendations for AI-enabled device software functions
- Draft guidance on considerations for the use of AI to support regulatory decision-making for drugs and biological products