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Predetermined Change Control Plans: Guiding Principles for Advancing Safe, Effective, and High-Quality AI-ML
Eduardo Carvalho1, Miguel Mascarenhas2,3,4, Francisca Pinheiro5
1Institute of Science and Innovation in Mechanical and Industrial Engineering (INEGI), Campus da FEUP Rua Dr. Roberto Frias, 400, Porto, 4200-465, Portugal, +351 229578710.
JMIR AI
|October 31, 2025
Summary
Artificial intelligence (AI) devices face regulatory hurdles due to their adaptive nature. Predetermined change control plans offer a solution to streamline approvals for evolving AI technologies.
Area of Science:
- Medical device regulation
- Artificial intelligence in healthcare
Background:
- Adaptive artificial intelligence (AI) offers significant benefits but challenges current regulatory frameworks.
- Lengthy approval timelines and repeated submissions hinder the adoption of AI-enabled devices.
Purpose of the Study:
- To explore the US Food and Drug Administration's (FDA) concept of predetermined change control plans.
- To assess how these plans can streamline regulatory oversight for continuously evolving AI technologies.
Main Methods:
- Review of FDA guidelines on predetermined change control plans.
- Analysis of the impact of these plans on AI-enabled device approval processes.
Main Results:
- Predetermined change control plans can reduce the need for repeated approvals for updated AI software functions.
- These plans aim to ensure safety and compliance while accelerating regulatory decisions.
Conclusions:
- Implementing predetermined change control plans can foster innovation and increase market uptake of AI and machine learning technologies.
- Streamlined regulatory oversight benefits both manufacturers and regulatory bodies by reducing burdens and wait times.
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