The FDA has issued updated guidance on Off-The-Shelf software in medical devices. The document, which supersedes a previous version issued in 2019, aims to provide guidance to medical device manufacturers on the appropriate use and documentation of OTS software in their devices.
Below, our Head of eHealth Paul Gardner provides a handy overview of the guidance.
When was this Off-The-Shelf software in medical devices guidance released?
The FDA issued this latest guidance document on Friday 11 August 2023. This version supersedes the Off-The-Shelf Software Use in Medical Devices guidance issued on 27 September 2019, with the original document having been issued back in September 1999.
What are the key aspects addressed in the guidance?
Premarket submission documentation – a risk-based approach
One of the key aspects addressed in the guidance is the documentation required for a premarket submission of a medical device that utilises Off-The-Shelf (OTS) software. The guidance stresses the importance of taking a risk-based approach to determine the level of documentation required, considering the risk associated with the medical device’s software function in the context of its intended use.
The document introduces two levels of documentation: Basic and Enhanced. The purpose of these levels is to identify the minimum amount of information necessary to support a premarket submission that includes device software functions.
An outline of the recommended documentation for each OTS software documentation element and the corresponding documentation level is included in the guidance. These elements include:
- the description of OTS software
- risk assessment of OTS software
- software testing as part of verification and validation, and
- assurance of development methodologies and continued maintenance of OTS software.
Considerations for OTS software in marketing applications
The guidance document addresses specific considerations for OTS software in marketing applications, such as master files for devices, OTS software changes requiring a 510(k), investigational device exemption & changes to OTS software, and premarket approval. It also discusses the importance of product labelling in relation to OTS software.
General considerations for OTS software & examples
Finally, to assist medical device manufacturers with their understanding and implementation of the recommendations, the guidance document appendices provide supporting information. Appendix A provides general considerations for OTS software, covering topics such as maintenance, obsolescence, and product configuration, whilst Appendix B provides examples of medical devices using OTS software.
Is the guidance legally binding?
The FDA emphasises that this guidance document represents their current thinking on the topic of OTS software in medical devices and does not establish any legally binding rights or requirements. The document also highlights that alternative approaches may be used – provided those approaches satisfy the premarket submission requirements outlined in applicable statutory provisions and regulations.