Artificial Intelligence-Enabled Device Software Functions: Lifecycle Management and Marketing Submission Recommendations

Draft Guidance for AI-Enabled Device Software Functions: Key Highlights

The FDA's draft guidance provides a comprehensive framework for the development, submission, and lifecycle management of AI-enabled device software functions (AI-DSFs). Aimed at industry and FDA staff, it emphasizes a Total Product Life Cycle (TPLC) approach to ensure safe, effective, and compliant AI-enabled medical devices.

Key Elements of the Guidance

• Total Product Life Cycle (TPLC) Approach
  • Focuses on the entire lifecycle of AI-enabled devices, from development to post-market surveillance.
• Addressing Transparency and Bias
  • Stresses the importance of transparency and strategies to mitigate bias in machine learning models.
• Alignment with Consensus Standards
  • Recommends incorporating software-related consensus standards and including supporting documentation in submissions with a Declaration of Conformity to recognized standards.
• Risk-Based Approach
  • Encourages sponsors to adopt a risk-based approach for testing and recommendations in marketing submissions.
• Predetermined Change Control Plan
  • Proposes the use of a Change Control Plan to manage planned modifications to AI-DSFs, ensuring compliance while enabling flexibility for updates.
• FDA Research and Experience
  • Draws on FDA's expertise in machine learning, deep learning, and neural networks, alongside relevant FDA guidance documents and regulations.
• Submission Best Practices
  • Advises sponsors to consult other relevant FDA resources and guidance documents for seamless marketing submissions.

Objective

The guidance aims to support industry compliance with FDA recommendations for AI-enabled devices, fostering innovation while prioritizing patient safety and device efficacy.

This document is a critical step toward creating a robust regulatory framework for AI in healthcare.

Source: https://www.fda.gov/media/184856/download

Region: United States of America