The new article highlights aspects related to the description of the software to be included in submissions associated with a medical device using it.


MHRA Guidance on Medical Software and Applications

The Food and Drug Administration (FDA or the Agency), the US regulating authority in the sphere of healthcare products, has published a guidance document dedicated to the use of off-the-shelf (OTS) software in medical devices.

The document provides an overview of the applicable regulatory requirements, as well as additional clarifications and recommendations to be taken into consideration by the parties involved in order to ensure compliance therewith.

At the same time, provisions of the guidance are non-binding in their legal nature, and they are not intended to introduce new rules or impose new obligations. Moreover, the authority explicitly states that an alternative approach could be applied, provided such an approach is in line with the existing legislation and has been agreed upon with the authority in advance.

Documentation Scope

The scope of the guidance covers, inter alia, the aspects related to the documentation the authority expects the applicants to include in submissions related to the products utilizing OTS software when applying for marketing approval. According to the document, software documentation elements to be included in submissions are:

  • Description of OTS Software – an overview and description of the OTS software and actions taken for the continued safe and effective use of the medical device;
  • Risk Assessment of OTS Software – risk assessment demonstrating that risks related to the use of OTS software have been appropriately mitigated;
  • Software Testing as part of Verification and Validation – test plans and results for the OTS software, commensurate with the Documentation Level (i.e., Basic or Enhanced) for the device;
  • Assurance of Development Methodologies and Continued Maintenance of OTS Software – for the Basic Documentation Level, this element is not required, however, the relevant information should be duly documented; while for the Enhanced Documentation Level, this should include information to provide an assurance that the product development methodologies used by the OTS software developer are appropriate and sufficient, and that mechanisms exist for assuring the continued performance, maintenance, and support of the OTS software. 

The document further describes in detail each of the abovementioned elements and highlights the key points associated with them. 

Description of OTS Software

According to the guidance, an overview and description of the OTS software features and functions should be included in the submission, irrespective of the applicable Documentation Level. In order to assist medical device manufacturers and other parties responsible for medical devices in complying with the said requirement, the authority outlines the scope of questions to be addressed when providing a description of the OTS software used in a medical device.

At the same time, the authority explicitly states that the below list is provided as an example, while the actual scope of matters to be addressed should depend on the specifics of the particular device in question and the OTS software used therein. The general idea is to ensure the information provided is sufficient for the authority to understand the functionality of the device subject to review.

General Information

As explained by the FDA, general information related to an OTS software component used in a medical device should cover the following aspects:

  • Title and Manufacturer of the OTS software;
  • Version Level, Release Date, Patch Number, and Upgrade Designation, as appropriate;
  • Any OTS software documentation that will be provided to the end user;
  • Why is this OTS software appropriate for this medical device?
  • What are the expected design limitations of the OTS software? 

The authority additionally emphasizes the importance of ensuring OTS software is used in line with the design history file. Furthermore, in the event of changes to the OTS software, such changes should be duly reflected in the relevant documentation. 

Additional Considerations 

The document further outlines additional considerations to be taken into account with respect to OTS software used in medical devices in terms of its description to be included in the respective submissions. 

First of all, it describes the Computer System Specifications of the OTS Software. On the hardware side, details are needed about the processor, memory, hard disk, and other components such as communications and display. On the software end, the specific operating system, drivers, utilities, and their versions need to be identified. It’s also important to mention any updates provided by the software manufacturer.

The guidance further focuses on ensuring the End User takes the right actions when using the product in question for its intended purpose. In particular, it is important to ensure clarity on how the software will be installed and configured. Questions to be addressed are related to the steps for installation, how often configurations might change, and what training is needed for users. It’s also vital to ensure that non-related software can’t be used on the device. Solutions could be through design adjustments, prevention methods, labeling, or even disabling certain device inputs. 

Another important aspect addressed in the guidance relates to the Function of the OTS Software. The main idea here is to understand what the software is meant to do in the medical device. Specific OTS components in the device design must be clear. It’s also important to know how the software handles errors and how it interacts with other software, especially those outside the medical device.

The present document also emphasizes the importance of verifying the software’s Functionality. Depending on the Documentation Level applicable to the device software, there’s a need to describe the processes of testing, verification, and validation of the OTS Software. The results of these tests should be made available to the authority for review. It’s also vitally important to maintain an up-to-date list of software issues and provide access to any updates.

The scope of the guidance also covers aspects related to the Management of OTS software. A solid plan should be in place to ensure:

  • The device can detect and prevent the use of incorrect software versions;
  • The software’s configuration is maintained effectively;
  • Proper storage solutions for the software are identified;
  • Proper installation methods are adhered to;
  • The software’s life cycle, including maintenance and support, is well-managed.

In summary, the present FDA guidance highlights the key points to be addressed in the submissions when providing a description of the OTS software used in a medical device. The document outlines the main elements of such a description and explains specific aspects to be covered in order to ensure the information provided to the authority is complete and sufficient to assess all the material matters related to the safety and performance of the device in general and OTS software in particular.  

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