The Food and Drug Administration (FDA or the Agency), the US regulating authority in the sphere of medical devices, has published a guidance document dedicated to software validation. The document is intended to provide additional clarifications and recommendations to be considered by medical device manufacturers and other parties involved to ensure compliance with the applicable regulatory requirements. At the same time, the guidance does not introduce new rules and requirements itself, and the provisions contained therein are non-binding in their legal nature. The authority additionally states that an alternative approach could be applied, provided such an approach complies with the applicable legislation and has been agreed with the authority in advance.


Software Development as Part of System Design 

In most cases, the decision to use the software to achieve particular functionality is taken by the medical device manufacturer in the course of the initial design development. Hence, the specifications the software should meet are usually based on the general specifications for the device itself. The latter is usually based on the particular user needs the medical device is intended to meet. Consequently, software validation must be considered within the context of the overall design validation for the system. 

The whole design development process is based on ensuring the final device will meet the requirements described in the specification. Thus, the software validation process is intended to demonstrate that the software the device contains also meets the appropriate specification and could be used for its intended purpose. The design valuation process in general should cover the aspects related to both the overall device and the software as a component thereof. According to the guidance, software validation includes confirmation of conformance to all software specifications and confirmation that all software requirements are traceable to the system specifications. The design validation is intended to ensure that the final device is suitable for its intended use and meets the appropriate user needs. 

Software is Different From Hardware 

The Agency additionally emphasizes that despite certain similarities in terms of the design development process, the approach to be applied to the software slightly differs from the one to be applied for the hardware. In particular, the document outlines the following main differences:

  • The quality of the final medical device depends not only on its design but also on the manufacturing process by the virtue of which the design is implemented into a product. At the same time, the quality of the software depends mostly on the design and development, while the “manufacturing” process is easily reproducible, and then the manufacturer can be sure that the actual performance of any copies of the software would be identical, so the main purpose of the manufacturer is to ensure the initial software operates as intended. 
  • The software is usually a complex element not only due to the number of components but also due to its ability to operate in different ways depending on the input. Sometimes it becomes difficult to understand exactly the way the software operates. 
  • Apart from testing, the manufacturer should duly carry out additional activities intended to ensure the software operates as intended. 
  • The concept of normal wear could not be applied in the case of the software. On the contrary, the software operates better after being used for a long period as this allows its manufacturer (developer) to identify most of the issues and make changes necessary to eliminate them. At the same time, changes to the software, including the ones intended to improve its performance, could result in new issues. 
  • The errors and malfunctions that occurred with the software are mostly unexpected due to their nature. As it was mentioned before, the software is a complex product and its performance could depend significantly on the input. Hence, some of the errors could remain unidentified for a long period since the appropriate path was not triggered. 
  • It is much easier to make changes to the software than to hardware devices. When combined with the complexity of the software, it could result in errors and malfunctions arising due to the low control standards applied. In this regard, the Agency states that because of its complexity, the development process for software should be even more tightly controlled than for hardware, to prevent problems that cannot be easily detected later in the development process. 
  • Even minor changes to the software could result in significant performance issues which could be hardly predicted. That is why the software development process should be subject to rigorous planning and control, and all the decisions taken should be duly documented. 
  • Healthcare professionals using the software as a final product are usually not involved in the software development process. Hence, the software should be accompanied with detailed enough documentation providing sufficient information necessary to ensure its use safely and efficiently. 
  • In most cases, software components are not standardized. At the same time, nowadays there is an ongoing process of moving towards component-based approaches. According to the guidance, the application of this approach requires special attention. In particular, the Agency states that before integration, time is needed to fully define and develop reusable software code and to fully understand the behavior of off-the-shelf components. 

In a summary, the FDA states that the development process requires even more attention than the appropriate process carried out about hardware medical devices. 


Benefits of Software Validation 

According to the guidance, software validation is vitally important to ensure the quality of the software and its correct operation, as it allows to reduce the failure rates, the number of recalls, and corrective actions to be taken by the manufacturer about the software and devices containing it, and also to mitigate the risks the patients are exposed to. Moreover, efficient software validation also allows reducing the overall development costs, especially in terms of software maintenance. It is stated that an established comprehensive software validation process helps to reduce the long-term cost of software by reducing the cost of validation for each subsequent release of the software. 


Design Review 

According to the guidance, design reviews stand for documented, comprehensive, and systematic examinations of a design to evaluate the adequacy of the design requirements, to evaluate the capability of the design to meet these requirements and to identify problems. Even though there could be numerous intermediate technical reviews in the course of the development process, there is a need for a structured and comprehensive design review. As described by the FDA, such reviews could be carried out about the software separately, or after integrating it into the product, or in both ways. The scope of the design review should cover such documents as development plans, specifications, testing plans, and other relevant documents. The Agency also encourages the manufacturers to conduct multiple design reviews. 

In summary, the present FDA guidance highlights the most important aspects of software validation and regulatory requirements associated thereto. The document outlines the points to be considered by the manufacturer in terms of software validation to ensure the effectiveness of the development process.



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