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High-definition Transcranial Direct Current Stimulation over Right Dorsolateral Prefrontal Cortex to Enhance Metacognitive Sensitivity
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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
PubMed
Summary
This summary is machine-generated.

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.

Keywords:
artificial intelligencehealth caremachine learningpredetermined change control plansregulation

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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.