The USA and European Approval pathways and regulations for AI/ML based Dental medical Devices: A Scoping Review Protocol.

OSF Preprints (OSF Preprints) 2026 Preprint

Authors: Faleh Tamimi, Kawthar Hasan Jasim, hala mansour, Tayeb Al-Hadeethi
Cited by: 0

Abstract

The integration of Artificial Intelligence (AI) and Machine Learning (ML) in dental devices has witnessed rapid advancements, raising questions about the regulatory landscape. This scoping review aims to comprehensively explore the FDA approval pathways and regulation requirements for already AI/ML dental devices.

Fields of Study & Subjects

Healthcare Regulation Artificial Intelligence in Healthcare and Education Digitalization Law and Regulation

Publication details

Journal / source
OSF Preprints (OSF Preprints)
Publication date
15 February 2026
Language
EN
Document type
Preprint