{"id":360028,"date":"2023-11-22T05:19:10","date_gmt":"2023-11-22T10:19:10","guid":{"rendered":"https:\/\/platohealth.ai\/hsa-draft-guidance-on-clinical-evaluation-general-principles-regdesk\/"},"modified":"2023-11-26T18:40:21","modified_gmt":"2023-11-26T23:40:21","slug":"hsa-draft-guidance-on-clinical-evaluation-general-principles-regdesk","status":"publish","type":"post","link":"https:\/\/platohealth.ai\/hsa-draft-guidance-on-clinical-evaluation-general-principles-regdesk\/","title":{"rendered":"HSA Draft Guidance on Clinical Evaluation: General Principles | RegDesk","gt_translate_keys":[{"key":"rendered","format":"text"}]},"content":{"rendered":"
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The new article highlights the aspects related to the general principles of clinical evaluation.\u00a0<\/span><\/p>\n<\/div><\/div>\n

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\t\t\t\t\"HSA<\/span>\n\t\t\t<\/div>\n<\/p><\/div>\n

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<\/span>Table of content<\/span><\/h2>\n<\/div><\/div>\n

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The <\/span>Health Sciences Authority <\/span><\/a>(HSA), Singapore\u2019s regulatory agency in the sphere of healthcare products, has published a guidance document dedicated to clinical evaluation of medical devices. <\/span>
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<\/span>The document provides an overview of the applicable regulatory requirements, as well as additional clarifications and recommendations to be taken into consideration in order to ensure compliance thereto. <\/span>
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<\/span>The authority also reserves the right to make changes to the guidance and recommendations provided therein, should such changes be reasonably necessary to reflect corresponding amendments to the underlying legislation.<\/span><\/p>\n

The document describes, inter alia, the general principles of clinical evaluation, including the scope of the evaluation, and the way it should be performed, and also addresses specific aspects related to the evaluation of in vitro diagnostic medical devices (IVDs) and software.<\/span><\/p>\n<\/div><\/div>\n

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<\/span>General Principles of Clinical Evaluation: Overview\u00a0<\/b><\/span><\/h2>\n

The clinical evaluation of a medical device is a critical and methodical process intended to ensure the safety and efficacy of a medical device throughout its entire lifecycle. <\/span>
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<\/span>This involves a detailed analysis of pre-market and post-market clinical data related to the intended use of the device. <\/span>
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<\/span>This data covers not only the specific clinical performance and safety information of the medical device but also considers any data from other devices that the manufacturer claims to be comparable. <\/span>
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<\/span>The general goal is to establish a robust evidence base that supports the clinical claims made by the manufacturer with respect to the device, its safety, and effectiveness, ensuring that all labelling and informational materials provided with the device, including contraindications, precautions, and warnings, are accurate and sufficient. The Instructions for Use must also be appropriate and user-friendly.<\/span><\/p>\n<\/div><\/div>\n

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<\/span>Clinical Evaluation Scope<\/b><\/span><\/h2>\n

According to the guidance, the scope of the clinical evaluation is vitally important and must be clearly defined from the very beginning. <\/span>
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<\/span>It should be aligned with the Essential Principles that are applicable from a clinical standpoint. This includes a careful examination of whether the device has any design features or is intended for target populations that necessitate specific attention.<\/span>
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<\/span>For example, the clinical evaluation should scrutinize any special performance or safety concerns presented by design features, such as the inclusion of medicinal, human, or animal components.<\/span>
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<\/span>The evaluation should also consider the intended purpose and application of the device, encompassing the target treatment group, disease conditions, proposed contraindications, and the method of application.<\/span>
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<\/span> Moreover, the specific claims about the device\u2019s performance and safety made by the manufacturer must be critically assessed. <\/span>
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<\/span>The evaluation scope should be described in the manufacturer\u2019s risk management documentation, which should outline the identified risks associated with the device and the strategies implemented to mitigate them. <\/span>
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<\/span>The clinical evaluation addresses the significance of any residual risks post-mitigation.<\/span><\/p>\n<\/div><\/div>\n

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<\/span>Comparable Devices and Clinical Evaluation<\/b><\/span><\/h2>\n

As further explained by the HSA, in evaluating a medical device, it is permissible to use data from comparable devices to support claims of safety and performance.<\/span>
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<\/span>However, this is conditional on the comparable devices having similar intended purposes, technical characteristics, and biological properties. <\/span>
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<\/span>These similarities must be carefully weighed against any differences that could potentially affect the safety and performance of the device under evaluation. <\/span>
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<\/span>Sometimes, the devices may be so similar that there is no clinically meaningful difference in safety and performance outcomes.<\/span>
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<\/span> Despite this, relying solely on data from comparable devices might not suffice for compliance with the Essential Principles, and additional clinical evidence might be necessary to fill any gaps.<\/span><\/p>\n<\/div><\/div>\n

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<\/span>Data Sources and Data Types for Clinical Evaluation<\/b><\/span><\/h2>\n

The selection of data sources and types for clinical evaluation is a complex process that must take into account the device\u2019s design, its intended purpose, and the associated risks. <\/span>
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<\/span>The nature of the technology upon which the device is based \u2013 whether it is a new or established technology \u2013 also plays a significant role. <\/span>
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<\/span>For devices that leverage established technologies intended for a known clinical application, the clinical evaluation may primarily rely on recognised standards, literature reviews, and clinical experience with comparable devices.<\/span>
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<\/span> In contrast, high-risk devices, those based on new or less familiar technologies, or those that extend an existing technology\u2019s intended purpose, will likely necessitate data from clinical investigations.
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<\/span>Product owners must carefully weigh the benefits and limitations of each type of data in the context of their specific device.<\/span><\/p>\n<\/div><\/div>\n

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<\/span>Clinical Evaluation: Process<\/b><\/span><\/h2>\n

Performing a clinical evaluation is a structured process that includes three discrete stages, namely:<\/span><\/p>\n