The Therapeutic Goods Administration (TGA), the Australian regulating authority responsible for medical device regulations, has published detailed guidelines describing how one can determine whether software falls within the scope of medical device regulatory framework. The document highlights the most important aspects to be considered in order to determine whether the software should be subject to regulation by the TGA.
The TGA states that certain software products (including mobile apps) could be subject to regulation as medical devices. The document provides an example of an app that organizes and tracks a person’s health information, and analyses the information to diagnose diabetes, or provide a percentage risk of the user having diabetes. The authority additionally emphasizes that the regulatory framework for medical software is subject to changes reasonably necessary due to technological improvements and extended use of software and mobile apps for medical purposes taking place nowadays. In this regard, in order to avoid unnecessary regulatory burden, the TGA has introduced numerous exclusions and extensions to be applied if the software product in question does not require special regulatory treatment due to the relatively low risks associated thereto.
The authority further outlines the main difference between exclusions and exemptions, namely:
- Excluded products are not medical devices, and are not subject to any TGA requirements;
- Exempt software is a medical device, but is not subject to all regulatory requirements. The authority also mentions that the guidance on Clinical Decision Support Software will provide detailed guidance on the exemption, including which products are covered, and which requirements still apply.
The present guidance is intended to assist medical device manufacturers (software developers) in determining the regulatory status of software and mobile apps. In particular, the document describes the approach to be applied in order to determine whether the software product in question should be regulated as a medical device or falls outside the regulatory framework as one intended for general health management and fitness software. For this purpose, the authority provides step-by-step flowcharts describing the way such a determination should be performed.
Regulatory Approach in Detail
The guidance provides the following clarifications:
- If the software constitutes an integral part of a medical device, such software should be considered as Software in a Medical Device (SiMD) and regulated as part of such device accordingly.
- If the software is neither intended for medical purposes nor intended to be used together with a medical device, it should not be considered a medical device itself.
- If the software is intended to be used for medical purposes but falls within the scope of a special exclusion, such software should not be subject to regulation under the medical devices framework.
- The software that is intended to be used in combination with a medical device by enabling or assisting with its functi on should be considered an accessory to a medical device, hence, be subject to regulation accordingly.
- If the software is intended to conduct operations with data obtained in vitro, it should be subject to regulation as an in vitro diagnostic medical device.
- The software intended to support clinical decisions should be regulated as a medical device unless it falls within the scope of a special exemption for clinical decision support software.
Definition of a Medical Purpose
One of the key concepts the TGA employs in the context of determining the regulatory status of software products is the concept of the intended purpose. According to the Therapeutic Goods (Medical Devices) Regulations 2002, an intended purpose stands for the purpose for which the manufacturer intends the product to be used. An intended purpose of a product could be indicated in the documentation accompanying the device, including the instructions for use or advertising materials used to promote the product. As stated in the guidance, if the software is intended for any of the purposes included in the definition of a medical device, it should be considered a medical device itself. In accordance with the applicable legislation, such purposes include:
- Diagnosis, monitoring, prediction, prognosis, treatment or alleviation of disease, injury or disability;
- Prevention of disease;
- Compensation for an injury or disability;
- Investigation, replacement or modification of the anatomy or of a physiological or pathological process or state;
- Control or support of conception.
Should the intended purpose of the software subject to review fall outside the scope outlined above, such software should not be treated as intended for medical purposes.
As mentioned, in certain cases, software intended for medical purposes could be exempted from regulation. In such a case, the software would not be subject to regulation under the medical devices framework but still should comply with the Australian Consumer Law. According to the guidance, the products that could be subject to exemption are those falling within the scope of the following categories:
- Consumer health products – prevention, management and follow up devices that do not provide specific treatment or treatment suggestions (for instance, software products and mobile apps intended to be used by laypersons for self-management of diseases that are not associated with severe negative consequences; as well as general wellness products or coaching software);
- Digital Mental Health (such as cognitive behavior therapy tools);
- Enabling technology intended to support telehealth, remote diagnosis, healthcare or dispersing (e.g. the one intended to transmit patient-related information or images, or to provide additional information, as well as clinical workflow management software);
- Digitisation of paper based or other published clinical rules or data including simple dose calculators and Electronic Patient Records (including the tools intended to calculate doses on the basis of the information provided in the respective standards);
- Population based analytics that do not drive outcomes for individuals (including the tools intended to collect and process the information related to the large groups and not the particular individuals);
- Laboratory Information Management Systems – systems to automate workflows, integrate instruments, manage orders and samples and associated information (except the products intended to generate report comments).
It is important to mention that the fact that the software product in question falls under one of the categories listed above does not itself mean that the software is excluded – the TGA additionally emphasizes that such software may be excluded.
Exemption For Clinical Decision Support Software
Certain software products intended to support clinical decisions could be subject to an exemption, provided they meet all three points listed herein below:
- Such software should not be intended to be used for processing data deriving from another medical device or medical image; and
- Should not have clinical decision support as the only function; and
- The information provided by such software should not substitute the appropriate decision to be taken by a healthcare professional.
In summary, the present TGA guidance highlights the most important aspects to be considered by medical device manufacturers (software developers) when determining the regulatory status of their products. The document contains flowcharts describing a step-by-step process to be followed in order to determine where the software product in question should be considered a medical device or general wellness product falling outside the scope of an existing regulatory framework.
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