The Therapeutic Goods Administration (TGA), the Australian regulating authority in the sphere of medical devices, has published a guidance document dedicated to software for use with COVID-19 rapid antigen self-tests. Apart from other aspects, the document describes the requirements for COVID-19 rapid antigen self-test software that is an in vitro diagnostic (IVD) medical device. As mentioned by the authority, the document is intended to provide additional clarifications and recommendations on ensuring compliance with the applicable regulatory requirements and is not binding in its nature. Moreover, an alternative approach could be applied, provided such an approach complies with the current legislation and has been approved by the authority in advance.
According to the guidance, matters related to the design and usability of the software intended to be used for a COVID-19 rapid antigen self-test, as well as the clarity of the instructions for use accompanying it, are especially important as such devices are intended to be used by laypersons having no special qualifications or knowledge. In particular, the authority states that the instruction for use should:
- Be well-designed, easy to read, locally adapted and user friendly;
- Clearly describe what the software does and how to set up and use it, including what to do when there are problems.
First, the guidance outlines the minimum certification requirements to be taken into consideration by software developers. These requirements include the following:
- The software developers should achieve and sustain compliance to the minimum conformity assessment certification requirements for Class 3 IVD medical devices. Hence, when applying for marketing approval, it would be necessary to provide evidence of a conformity assessment carried out by a third party entitled to carry out an assessment of medical devices of such type (this could be the Australian TGA or foreign regulating authority in the sphere of medical devices).
- The software developers are also obliged to demonstrate that their product complies with the applicable essential principles as set forth by the Therapeutic Goods (Medical Devices) Regulations 2002.
As it is further stated by the TGA, a certification provided by a foreign regulating authority that will be found admissible by the TGA includes:
- Certificates and reports issued under the Medical Device Single Audit Program (MDSAP),
- ISO 13485:2016 certificates issued by:
- A certification body that is also a Notified Body designed under the IVDD 98/79/EC (for IVD inclusion applications only until 26 May 2022),
- A body that is an accredited body that is a signatory to the Multilateral Recognition Arrangement of the International Accreditation Forum (IAF MLA) (for IVD inclusion applications only until 26 May 2022);
- Certificates issued by Notified Bodies designate by the medical device regulators of European member states, under the medical device regulatory frameworks of the IVD Regulation;
- United States Food and Drug Administration (FDA) premarket approval (PMA).
The authority additionally emphasizes that in order to be admissible, a certification described above should be duly obtained by the medical device manufacturer prior to applying for marketing approval in Australia. The authority also mentions that in some cases, both the test and the app are manufactured (developed) by the same manufacturer, and in others – by different entities. In the first case, it would be sufficient to submit an application covering both elements, while in the second case, two separate applications would be required.
Clinical Performance and Usability Studies
As mentioned in the guidance, it is vitally important to ensure the software intended to be used with a COVID-19 rapid antigen self-test does not impact the accuracy and reliability of test results. On the contrary, the software should improve these parameters instead. Hence, in order to evaluate the actual performance of tests and software, the following testing should be performed:
- The use a test together with software it is intended to be used with; and
- The use of a test separately.
By comparing the results of the testing carried out as described above, one can evaluate the actual performance of the COVID-19 rapid antigen self-test and the impact on the results caused by the software (if any).
Additional usability and user comprehension studies should be duly performed in order to evaluate the ease of use for the potential users. As mentioned, in the case of self-test IVD medical devices it is important to ensure that laypersons can use them in a safe and efficient way in accordance with the information provided in labeling or instructions for use.
According to the guidance, test results should:
- Evaluate the ease of use of the software with a minimum of 100 lay users;
- Reflect a range of results including non-reactive, reactive, weak reactive and invalid; and
- Provide a determination of concordance against visual reading of the test result by the lay user without the software (if applicable).
Thus, it is the sole responsibility of a party applying for marketing approval for the software intended to be used with COVID-19 rapid antigen self-tests to demonstrate, by providing the appropriate evidence, that the software used for interpretation of the results does not impact the clinical sensitivity and specificity.
Apart from the general requirements described above, the present TGA guidance also covers aspects related to the applicable technical requirements to which the software could be subject. The authority especially emphasizes the importance of simplicity and ease of use for the intended users of the software. As in the case of self-tests, the users will have no special education or training. The main technical requirements cover such aspects as:
- Software infrastructure;
- Validation artefacts;
- Defect management process;
- Evaluation of the impact caused by human factors (especially in the case of medical devices intended to be used by laypersons);
- The risks related to cybersecurity, as well as the measures duly implemented to address such risks;
- Data protection;
- Readability and clarity of the instructions;
- Minimum requirements for the platform the software is intended to operate on (in case of mobile apps – smartphone);
- Image resolution: according to the present guidance, the minimum resolution for images used by an app for recording images of results should be 1920×1080 (horizontal) resolution.
In summary, the present TGA guidance highlights the most important aspects to be considered by medical device manufacturers (software developers) with regard to the software intended to be used with COVID-19 rapid antigen self-tests. The document outlines the key points arising from the specifics of the use of such software – the use by laypersons. The document provides additional recommendations to be taken into consideration when performing clinical trials or applying for marketing approval in Australia.
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