FDA Requirements for Using Off-The-Shelf Software in New Medical Devices
(Thursday, August 17, 2023)
In the dynamic landscape of medical device innovation, the utilization of off-the-shelf (OTS) software has become a cornerstone for rapid development and enhanced functionality. However, it is hard for the developers of devices to include most details about the OTS software, the kind of which would be available to in-house software. To allow device developers to address the regulatory requirements when using OTS software, the FDA proposes a least burdensome approach to address the regulatory requirements.
FDA’s prior guidance on the topic was focused primarily on hazard analysis to assess software suitability, however, it failed to discuss the practical considerations surrounding use of OTS products. The new approach minimizes information requirements while ensuring the safety and effectiveness of devices featuring OTS software.
Central to the updated approach is the imperative for sponsors to submit a comprehensive risk management file and plan. The risk management plan should articulate the addressed and residual risks with the use of the OTS software, while the risk management file should encompass a detailed risk assessment highlighting effective risk mitigation strategies. The documentation of potential risks associated with the software's usage could meet the regulatory requirement of ensuring a robust risk management framework that aligns with the overarching objectives of medical device safety and effectiveness.
The updated guidance also forgoes the assumption of Manufacturer Good Software Development Practices (GSDP) and Good Corrective Action Practices (GCAP), shifting the emphasis towards ensuring the continued functionality of OTS software throughout the lifecycle of the device. This shift encompasses a holistic evaluation of factors such as safety, effectiveness, design, software testing, change management, installation, and decommissioning concerns. FDA also suggests that the owners of the OTS software submit a Device Master File (DMF) to the FDA containing elements of the software development program and other proprietary information that they may not want to share with their customers, thereby making it easier for device manufacturers to use their OTS products.
In elucidating the comprehensive evaluation, the FDA underscores the significance of considering the probable risk of death or serious injury to patients, device users, and others in the usage environment. This risk-based approach encourages sponsors to tailor their evaluation strategies, thereby ensuring that their medical devices achieve optimal safety and performance outcomes.
The new guidance document reflects FDA’s acknowledgement that it needs a practical approach to satisfy regulatory requirements for patient safety and device effectiveness while fostering innovation. By mandating a robust risk management framework and streamlining documentation requirements, the FDA empowers medical device sponsors to navigate the intricate landscape of OTS software integration with confidence and compliance. This guidance should be a great resource for medical device developers who want to use OTS software but were concerned about the additional burden of meeting FDA’s requirement by suggesting least burdensome approaches to compliance.
Dr. Mukesh Kumar
Founder & CEO, FDAMap
Linkedin: Mukesh Kumar, PhD, RAC