SFDA Rejects AI-Powered Diabetes Prediction Device for Failing Safety and Efficacy Standards

The Saudi Food and Drug Authority (SFDA) has rejected a marketing authorization application in the Kingdom of Saudi Arabia for a software medical device designed to predict the likelihood of developing Type 2 diabetes within the next four years in adults over 18. This AI and machine learning-powered device, despite being marketed in some European countries, failed to meet the Kingdom's safety and efficacy requirements.

Thorough Evaluation Preceded the Decision

Given that diabetes poses a significant chronic health challenge in the Kingdom, the SFDA conducted a thorough scientific evaluation of the application. This extensive review included assessing the device's efficacy, the validity of its clinical claims, and the reliability of its AI-driven analysis techniques.

Lack of Requirements Prevented Approval

The evaluation of technical documentation revealed that the device did not meet the necessary safety and efficacy standards. Specifically, its verification reports and documentation for the underlying AI algorithms were weak. Clinically, the provided data were insufficient. The clinical study lacked a sample representative of the local Saudi population, despite the device's broad intended use. No scientific explanation was offered to justify the generalizability of the study results to the local demographic, raising significant concerns about the device's suitability for the Saudi market. The manufacturer also failed to demonstrate sufficient compliance with international specifications for medical software development, and did not provide a clear risk management plan or post-marketing update mechanism.

Adherence to the Saudi Standards is Paramount

The SFDA emphasized that the device's marketing approvals in European countries do not supersede full compliance with regulatory requirements approved in the Kingdom. Scientific consultations confirmed significant deficiencies in both the analytical data and the clinical evidence provided.

Ensuring the Safety of Medical Devices is a Firm Commitment

The SFDA remains firmly committed to protecting patient health and ensuring the safety and effectiveness of all approved medical devices. This includes promoting the localization of clinical studies and fostering innovation and modern technology in the Kingdom, all in line with the highest scientific and regulatory international standards. The SFDA strongly recommends that manufacturers conduct local clinical studies within Saudi Arabia to ensure device performance aligns with local demographic and medical characteristics, thereby meeting essential safety and effectiveness criteria.