The U.S. Food and Drug Administration recently issued its first-ever draft guidance on the use of AI for the development of drug and biological products. Entitled “Artificial Intelligence-Enabled Device Software Functions: Lifecycle Management and Marketing Submission Recommendations,” it serves as a critical framework for managing AI-enabled medical devices throughout their lifecycle and provides recommendations for marketing submissions.
ASSISTING IN THE DEVELOPMENT OF MEDICAL PRODUCTS
The primary motivation behind this guidance is to facilitate the development and deployment of safe and effective AI-enabled medical devices, with FDA Commissioner Robert M. Califf, M.D. providing in a related statement that “[w]ith the appropriate safeguards in place, artificial intelligence has transformative potential to advance clinical research and accelerate medical product development to improve patient care.” The guidance is said to aim to strike a balance between fostering innovation and ensuring patient safety.
KEY IMPLEMENTATION MECHANISMS
The guidance document implements its objectives through several key mechanisms:
Total Product Life Cycle (TPLC) ApproachThe guidance
The guidance emphasizes comprehensive lifecycle management, stating that “the resources provided in this guidance are … intended to assist with the device development and lifecycle management of AI-enabled devices, which should help support the safety and effectiveness of these devices.”
The document further elaborates: “This guidance provides both specific recommendations on the information and documentation to support a marketing submission for an AI-enabled device, as well as recommendations for the design, development, deployment, and maintenance of AI-enabled devices, including the performance management.”
Transparency and Bias Management
The guidance addresses critical concerns about “transparency and bias throughout the TPLC of AI-enabled devices.”
Quality System Integration
The draft guidance explains that certain documentation relevant to Quality System (QS) regulation for medical devices in general “can also be provided premarket to demonstrate how a sponsor or manufacturer is addressing risks associated with AI-enabled devices specifically.”
Comprehensive Device Description Requirements
A detailed device description is required to support “FDA’s understanding of the intended use, expected operational sequence of the device, use environment, features of the model, and design of the AI-enabled device.” This includes the following:
- A statement that AI is used in the device.
- A description of the device inputs and device outputs, including whether the inputs are entered manually or automatically, and a list of compatible input devices and acquisition protocols, as applicable.
- An explanation of how AI is used to achieve the device’s intended use.
- A description of the intended users, their characteristics, and the level and type of training they are expected to have and/or receive.
- A description of the intended use environment.
- A description of the intended workflow for the use of the device
- A description of installation and maintenance procedures.
Additional Critical Areas
The guidance also covers user interfaces, risk assessment, data management, validation, device performance, and cybersecurity.
WHO THE GUIDANCE IS FOR
This guidance is intended for the industry (companies developing and manufacturing AI-enabled medical devices) and FDA staff involved in the review and regulation of these devices.
COMMENT PERIOD
The draft guidance is subject to a comment period, allowing stakeholders to provide feedback and suggestions for improvement. Electronic comments and suggestions should be submitted to https://www.regulations.gov within 90 days of publication in the Federal Register of the notice announcing the availability of the draft.
Categories: AI
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