Biologics

FDA Cross-Center AI Paper Analyzed

Four Hogan Lovells attorneys say a discussion paper published by CBER, CDER, CDRH, and the Office of Combination Products on artificial intelligence (AI) and medical products aims to provide greater transparency on how the agency’s Centers are collaborating to safeguard public health while fostering responsible and ethical innovation. The attorneys say the paper says that AI management requires a risk-based regulatory framework built on robust principles, standards, best practices, and state-of-the-art regulatory science tools that can be applied across AI applications and tailored to the relevant medical product.

The FDA paper highlighted these four cross-collaboration goals:

fostering collaboration with developers, patient groups, academia, global regulators, and other interested parties;
advancing the development of regulatory approaches that support innovation;
promoting the development of standards, guidelines, best practices, and tools across the product lifecycle; and
supporting research related to the evaluation and monitoring of AI performance.

Manufacturers, the attorneys write, should consider developing policies and procedures that provide governance for the responsible use of AI and other digital tools used in medical product development. They suggest that manufacturers consider developing policies that address:

bias mitigation and generalizability;
transparency and auditability;
consent, training, and access;
third parties;
privacy and cybersecurity; and
independent input and oversight.

“The discussion paper suggests that FDA is considering what roles each product Center will play in regulating use of AI in medical product development, regardless of whether AI is the end product,” the paper concludes. “It is likely that FDA’s approach to building capacity to regulate AI among its product centers may involve developing new Centers of Excellence….”

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Gupta Raises Concerns About Overton’s Independence, Ideology

Overton Confirmation Remains Uncertain After Senate Hearing

FDA Classifies Boston Scientific Imager II Catheter Recall as Class I

FDA Approves Gazyva for Childhood-Onset Idiopathic Nephrotic Syndrome