Prequalification of priority medical Devices (MDV)
Introduction
WHO Prequalification is in the process of establishment of prequalification process for computer-aided detection software used for the automated interpretation of digital chest radiography for tuberculosis (CAD for TB) for use in both screening and triage use cases. This is a pathfinder for the establishment of the prequalification process for priority medical devices (MDs) and personal protective equipment (PPE).
Over the last years, the interest of manufacturers in CAD products for diagnostics, including for TB, has grown and numerous products are already available on the market (e.g. https://www.ai4hlth.org/). New WHO guidelines for TB screening released in March 2021 recommended CAD for TB for the first time for screening and triage use cases. This is also the first time that software employing artificial intelligence is recommended in a WHO TB guideline. The evidence reviewed for the guidance included an independent assessment of the performance of three commercially available software products on a library of digital radiographs. The WHO guidance does not specify which software product is approved. Alongside the release of the new guidelines WHO commissioned work to start developing procedures on how to assess the quality and performance of software products that manufacturers will submit for prequalification.
The Technical Specifications Series documents (TSS) set out the performance evaluation criteria for meeting prequalification requirements. Each TSS document provides information on the minimum performance requirements for WHO prequalification that should be met by a manufacturer to ensure that the medical device that is being submitted for prequalification is safe and performs optimally.
Reviewing and commenting on the TSS for CAD for TB
We invite you to review the draft working document on Technical Specifications Series for submission to WHO Prequalification – Medical Device Assessment Screening and Triage of TB using Computer Aided Detection Software for Interpretation of Chest X-Ray Images. Please find attached the PDF file of the document.
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Your comments on this document should be submitted by 30 April 2024. Please note that only comments received by this deadline will be considered.