The new article provides additional clarifications regarding the regulatory status of software products with different types of supply, including software to be installed, cloud solutions, and complex products composed of multiple elements.
The Brazilian regulating authority in the sphere of medical devices (ANVISA) has published a guidance document dedicated to the products subject to regulation within the Software as a Medical Device (SaMD) framework. According to the guidance, this category covers a wide range of products having various intended purposes and used for diagnosing and treatment. In particular, the authority outlines the key criteria to be taken into consideration when determining the regulatory status of the product based on its functionality and intended use. It is important to mention that provisions of the guidance are non-binding in their legal nature, nor are intended to introduce new rules or impose new obligations, but rather to provide additional clarifications and recommendations to be taken into consideration by medical device manufacturers (software developers) and other parties involved in order to ensure compliance with the applicable regulatory requirements. The guidance itself is structured as a Q&A document containing questions from industry representatives regarding the products they are responsible for, and also the answers provided by the authority.
Mobile App for Physical Evaluations
One of the examples provided in the guidance describes an application intended to be used on mobile platforms as an interactive tool to assist in physical evaluations. According to the explanation provided by the manufacturer (developer), the software is intended for professional use by physiotherapists and professors of physical education. The application will use a neural network to analyze the images (photos) of patients, calculate the compression, and measure angles using specific points to be assigned automatically (however, a person using the software will be able to change and re-assign them). The application will conduct the assessment and provide a result in quantitative values. Based on such an assessment, the application will trace suggestions of possible causes and consequences for each alteration observed. Furthermore, the manufacturer mentions that a similar assessment could also be conducted using video, on the basis of records made by a user.
As explained by the authority, the program product intended to assist in physical assessments by performing static or dynamic assessments through images with the use of artificial intelligence (AI) falls under risk class II for regulation 10 and must be regularized by the Equipment Technology Management. At the same time, such software will fall within the scope of the innovative technology concept and, consequently, would not be subject to clinical analysis in accordance with the regulation RDC No. 548/2021 and respective clinical research standards. It is further stated that in the case of software products based on the AI technology used to achieve their intended purpose, the authority expects its manufacturer (developer) to provide a solid rationale with respect to the application of the said technology, as well as to such specific aspects as the size of the databases used and history of training conducted, as well as a detailed enough description of the information used for learning activities. The abovementioned factors are vitally important since, in the case of AI-based solutions, the quality of the initial data used to train the AI would impact its actual performance, as well as the reliability and accuracy of the results the software provides. That is why the authority encourages medical device manufacturers (software developers) to pay additional attention to these matters.
Autonomous Software with Connection Features
Another example provided in the document is related to autonomous software that can be configured to connect to laboratory equipment. The authority explains that such a software will not be subject to regulation as a SaMD since its functions and intended purpose are falling outside the scope of the definition of a medical device as set forth under the current regulatory framework. Hence, such products would not be subject to registration in order to be allowed for marketing and use in the country. The same approach applies to other software solutions intended for merely administrative purposes, including various types of data transmission functions, etc.
Similarly, telemedicine applications, the functionality of which is limited to ensuring interactions between healthcare professionals and patients, are not subject to regulation as medical devices due to the scope of their functions and features. At the same time, should an application be intended for the collection of physiological data and/or its further assessment, such software could actually fall within the scope of the SaMD regulatory framework.
Computerized System for Remote Collaboration
The authority also mentions that the approaches described in the guidance remain applicable irrespectively of the specific way the software is provided (supplied). In general, the software could be provided as a package to be downloaded (and later installed on a specific device), or accessed online as a cloud solution. Depending on the need in connection to a global or local network, software solutions could be divided into autonomous and the ones that do actually require to be connected to a network of any type. In all cases, the main principles related to functionality and intended purpose would still apply when it comes to determination of the regulatory status of such products.
For instance, one of the examples provided by the industry describes a computerized system to support image diagnoses with remote collaborators, which will work with encrypted databases to be stored in a cloud. It is also stated that the said system will not obtain images directly. As explained by the authority, such a system will not be subject to regulation as a SaMD since its intended use is limited to ensuring the images are stored in a protected environment and are accessed by authorized parties having the necessary permissions. At the same time, in the cases the system will have visualization and treatment functions, the medical devices regulatory framework will apply.
In summary, the present ANVISA guidance highlights certain important points related to the regulatory requirements for software-based products. The document describes various examples of software with different intended use and functionality and outlines the key factors to be taken into consideration when determining their regulatory nature.
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