Artificial Intelligence and Machine Learning for In Vitro Diagnostics

Overview

The AI/ML project aims to build on AI/ML best practices designed for imaging and other applications to develop an industry perspective on a predetermined change control plan (PCCP) for other AI/ML-enabled medical devices, including IVDs.

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Predetermined Change Control Plans for AI and ML-enabled Medical Devices

Building on frameworks released by the FDA and other global regulatory agencies, this resource is intended to help stakeholders understand a possible approach to planning and implementing iterative improvements to AI/ML-enabled medical devices. The resource provides consideration for developing a Predetermined Change Control Plan (PCCP), including essential elements such as the Description of Modification (DOM), Modification Protocol, and Impact Assessment.

Discover how a detailed PCCP is essential for managing post-market changes to AI/ML-enabled medical devices, ensuring future updates are proactively communicated, validated, and maintain the safety and effectiveness of the device.

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AI/ML Working Group

Active AI/ML Working Group members represent the following IVD stakeholders:

  • Agilent
  • Becton Dickinson
  • Escavo
  • Philips
  • Precision Medicine & Diagnostics
  • Roche

Explore ClinDx Resources

IVD RWE Education Series Module 1: Application of the MDIC IVD RWE Framework

SRS Landscape Analysis Report

Study Design Blueprint for Evaluating Analytical Performance Characteristics of Point of Care In Vitro Diagnostic Devices with Capillary Whole Blood (Fingerstick) Specimens