The new article highlights the critical points associated with the concept of intended use and clarifies the approach to be applied concerning risks associated with in-house medical devices.
Table of content
The Saudi Food and Drug Authority (SFDA), the country’s regulatory agency in healthcare products, has published a guidance document dedicated to developing in-house in vitro diagnostic (IVD) medical devices healthcare institutions may create to meet their internal needs.
The document provides an overview of the applicable regulatory requirements, as well as additional clarifications and recommendations to be considered by healthcare institutions and other parties involved in operations with medical devices to ensure compliance to it, as well as the continuous safety of patients.
The authority also reserves the right to change the guidance and recommendations provided therein, should such changes be reasonably necessary to reflect corresponding amendments to the underlying legislation.
Intended Purpose
The scope of the guidance covers, among other things, the aspects related to one of the key concepts associated with medical devices – the intended purpose.
As explained by the SFDA, the development of IVD tests must aim to meet the needs of patients and clinicians, providing clinically relevant information without necessarily being the best in class. Key to this process is considering the Essential Principles throughout the test design, in line with the Quality Management System (QMS), ensuring the data generated supports the test’s intended use as outlined in labeling and the Medical Device Application Form MDS-G009 Annex 1.
The intended purpose should detail what is detected/measured, including considerations for potential interference, the test’s function (e.g., screening, diagnosis, prognosis), and the specific information the test result provides.
Risk Management
In addition to the above, the parties involved in the design and development of in-house IVDs should pay special attention to risks associated with it to ensure patients won’t be exposed to unjustified risks when these devices are used for their intended purpose.
According to the document, risk management begins in the design phase, identifying potential harms and analyzing hazards that could lead to damage.
It evolves throughout the design process, guiding the development and determining necessary verification and validation data.
Hazards considered include false results or delays, with risk being a combination of the severity of harm and the likelihood of occurrence.
Design strategies aim to prevent harm, considering potential interferences and optimizing reagent formulations. Verification studies challenge these interferences to ensure minimization, contributing to the technical documentation.
Performance
The document also describes the aspects related to the actual performance of medical devices in terms of the results achieved when using them in clinical settings.
As explained by the authority, performance covers both analytical and clinical aspects. Analytical performance focuses on accurately generating results, while clinical performance assesses the ability for consistent and accurate result generation across the intended population.
Performance data, supported by patient samples acquired under appropriate ethics, is crucial for commercial and in-house tests.
The variability in the user group’s size and diversity, especially for in-house tests, necessitates careful consideration to ensure consistent results.
Commercial assays typically validate clinical performance across multiple sites, a standard that may be adapted for in-house assays with justified technical documentation.
Clinical and Laboratory Standards Institute (CLSI)
The CLSI is recognized globally for developing laboratory standards that enhance medical laboratory testing. It provides extensive knowledge on conducting analytical and clinical performance studies, crucial for achieving reliable and accurate IVD test results.
Conclusion
In summary, the present SFDA guidance emphasizes the critical aspects of developing IVD tests, from defining their intended purpose to managing risks and ensuring robust performance.
By following these principles and utilizing resources such as the relevant standards, developers can ensure that their IVD tests meet the necessary requirements for clinical relevance, safety, and efficacy, and thus could be used to address the unmet needs of specific healthcare institutions.
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