The article provides a general overview of the Risk Assessment and Software testing for Off-The-Shelf Sftware as given by FDA.
Table of Contents
The United States Food and Drug Administration has released a guidance document about Off-The-Shelf (OTS) software used in medical devices.
This document explains the regulatory requirements within the current legal framework and provides additional clarifications for medical device manufacturers about risk assessment and software testing to be included in marketing submissions.
It’s essential to note that this guidance’s provisions are non-binding and don’t create new rules or obligations.
The FDA allows for alternative approaches if they align with existing legislation and have prior approval from the authority.
Risk Assessment of OTS Software
In accordance with the FDA’s guidance document, “Content of Premarket Submissions for Device Software Functions,” it is crucial to include a risk management file in premarket submissions for device software. This file is required for both Basic and Enhanced Documentation Levels and should include:
– A clear risk management plan outlining how the sponsor intends to assess overall residual risk.
– A comprehensive risk assessment demonstrating effective risk mitigation.
– A final risk management report.
For off-the-shelf (OTS) software, it is essential to provide detailed descriptions of the risks associated with the software functions used in the device within the risk management file.
Additionally, the FDA offers further clarification and recommendations in the guidance document titled “Content of Premarket Submissions for Device Software Functions.”
Software Testing as Part of Verification and Validation
According to the FDA, medical device parties must provide documentation on test plans and outcomes. This is essential for verifying and validating off-the-shelf (OTS) software. It’s important to note that testing for OTS software goes beyond what the software developer does; it also includes tests performed by the medical device party to ensure software suitability for the specific device.
Depending on the Documentation Level (Basic or Enhanced), medical device manufacturers should:
– Describe the software’s testing procedures, ensuring they address potential hazards from the risk management file.
– The authority recommends clearly identifying the exact OTS software version used for testing. This version should be used to ensure result accuracy and reliability.
Testing should encompass activities by the medical device party for software qualification, and it may include tests by the initial OTS software developer.
– Provide test results. If a manufacturer uses different OTS software versions, they must validate the device for each version.
– Present a current list of OTS software defects.
Development Methodologies and Maintenance
According to the guidance, for medical devices under the Enhanced Documentation Level, the following recommendations apply:
- Manufacturers must ensure that the product development methodologies used by the initial OTS software developer are suitable for the specific medical device’s intended use.
- This involves reviewing the design and development methods used for the OTS software. The review should thoroughly examine the associated development and qualification documents. If providing this assurance is challenging or if residual risk evaluation after risk control measures are taken is unacceptable as per the risk management plan, using the OTS software for that specific medical device may not be advisable.
- Sponsors should demonstrate effective mechanisms to ensure consistent performance, maintenance, and support of the OTS software. The guidance also stresses the importance of addressing potential changes the original developer may make to the software or the potential discontinuation of support.
In summary, the FDA guidance covers crucial aspects of risk assessment for OTS software in medical devices. It also outlines the testing approach to ensure the software aligns with the device’s specific requirements.
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