The Therapeutic Goods Administration (TGA), the Australian regulating authority in the sphere of healthcare products, has published a guidance document dedicated to software intended to be used with in vitro diagnostic medical devices during the outbreak of Coronavirus Disease 2019 (COVID-19) caused by the virus SARS-CoV-2 or the “novel coronavirus.”
The document describes the approach to be applied when determining the regulatory status of the software in question and also provides additional clarifications and recommendations to be considered by medical device manufacturers (software developers) intending to place their products on the country’s market. It is also important to mention that the provisions of the guidance are non-binding in their nature, so in case of any discrepancies with provisions of current legislation, the latter should prevail.
Apart from general principles, the guidance also highlights some specific aspects, including the following:
- Requirements for software using artificial intelligence,
- Requirements for the instructions for use (IFU),
- Post-market monitoring and standard conditions of inclusion,
- Additional costs that may be applied,
- Post-market review.
Additionally, the guidance describes in detail how the approach described therein should be applied by medical device manufacturers (software developers) and other parties involved.
Requirements for Software Using Artificial Intelligence (AI)
As mentioned, the guidance also addresses the regulatory matters associated with the use of AI-based software, as well as the software based on machine learning (ML) technology. In such cases, the authority emphasizes the importance of transparency: the applicant should describe in detail the way the software operates in order to ensure the authority will be able to evaluate the safety and effectiveness of the software in question. The TGA explicitly states that a “black box” approach would not be considered acceptable.
The guidance further outlines the scope of information to be provided by the applicant with regard to AI/ML-based software. According to the guidance, the applicant should indicate the objectives of the software, provide a comprehensive description of the algorithm and model used, as well as sufficient information regarding the data used for training and testing, since the accuracy and reliability of data impact the overall effectiveness of the software significantly. With regard to data, the TGA emphasizess the following:
- Synthetic data would not be considered suitable,
- Size of data sets must be sufficiently large to be statistically credible,
- Information about populations that this data is based on and justification for how this data would be appropriate for the Australian population who will be using the tests.
It is important to mention that for the purpose of the present guidance, the definition of a “medical device manufacturer” covers software developers.
Requirements for the Instructions for Use (IFU)
When submitting a software for review, its manufacturer should clearly indicate the particular COVID-19 rapid antigen tests it is intended to be used with and also outline the scope of information accompanying the software when being supplied. In particular, the manufacturer should provide the following details:
- Detailed enough instructions describing the way the software should be used in order to ensure the accuracy of the results;
- How the instructions for use are provided (e.g., in paper form or a file available for downloading), including the details regarding language versions;
- Recommendations on further actions in case the result is positive;
- How the customer using the software can contact support service;
- How the customer can contact the regulating authority in order to notify about any performance-related issues.
In terms of labeling, the present TGA guidance also refers to the general regulatory requirements on labeling set forth under the Medical Device Regulations.
Post-Market Monitoring and Standard Conditions of Inclusion
The TGA also mentions that the manufacturers (software developers) should still comply with any and all regulatory requirements set forth under:
- The Therapeutic Goods Act 1989;
- The Medical Device Regulations; and
- The Therapeutic Goods Advertising Code.
In particular, these requirements include the inclusion of a product subject to regulation in the Australian Register of Therapeutic Goods (ARTG), the country’s register of medicines and medical devices. Additionally, the manufacturers should comply with the applicable regulatory requirements related to post-market monitoring, which include the following:
- Allowing entry and inspections of premises;
- Delivery of device samples upon request;
- Availability of information, such as facilitating access to technical documentation that demonstrates compliance with the essential principles;
- Ensuring any advertising material relating to the medical device complies with regulatory requirements;
- Reporting details of certain incidents and performance issues to the TGA, and any overseas regulatory actions to the TGA if the product involved is from the same batch or production run that was supplied in Australia.
The authority additionally emphasizes that all the adverse events associated with medical devices placed on the Australian market should be duly reported by the parties responsible for such devices.
Apart from the key points outlined hereabove, the document also provides additional clarifications and recommendations regarding certain specific aspects the parties involved in operations with the software intended to be used with COVID-19 rapid antigen self-tests should consider. In particular, it is stated that the authority is entitled to impose additional requirements on a case-by-case basis, should it be reasonably necessary to ensure the safety and effectiveness of tests due to their specific features or intended use. For instance, the authority may require the applicant to:
- Provide its customers with 24/7 support services;
- Duly notify the authority on any and all false positive and false negative results, once the applicant becomes aware of such cases;
- Submit the annular reports containing comprehensive information regarding the supply and activity of the customers (e.g., numbers of apps downloaded, users registered, services provided, etc.), however, in certain cases, more frequent reporting could be requested as well;
- Make the devices available only through specified distribution channels ensuring the devices are supplied to the customers accompanied by necessary information.
Thus, as mentioned, the TGA as a county’s regulating authority may impose additional requirements depending on the particular software in question and risks associated thereto.
Once COVID-19 rapid antigen self-tests would be placed on the market, they would be subject to the general post-market review requirements as well. In particular, a party responsible for such devices could be requested to provide a certain number of devices for assessment by an independent laboratory.
In summary, the present TGA guidance highlights the most important aspects associated with the software intended to be used with COVID-19 rapid antigen self-tests. In particular, the guidance provides additional clarifications regarding the regulatory requirements the parties responsible for such software should comply with.
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