September 26, 2025

On September 24, 2025, the U.S. Food and Drug Administration (FDA) issued its long-awaited final guidance, “Computer Software Assurance for Production and Quality System Software.” This guidance is a landmark shift in how medical device manufacturers should approach the validation of software used in production and quality processes. While device-embedded software or software that functions as a medical device itself remains governed by existing regulations, this new framework specifically addresses tools that support manufacturing and quality functions, such as electronic training systems, nonconformance tracking, complaint handling software, and product lifecycle management tools.

The FDA’s objective is clear: create a more flexible, risk-based system for ensuring that such software is reliable and appropriate for its intended use, while reducing the unnecessary burdens that often discourage adoption of advanced digital technologies. This shift not only modernizes regulatory expectations but also opens the door for greater efficiency and innovation across the industry.

One of the most important clarifications in this guidance is defining which software falls under its scope. The FDA specifies that only software used in production and quality system activities is covered. This includes systems that directly impact device manufacturing, quality control, complaint handling, training, and related compliance functions. General business tools, such as email systems, financial accounting software, or HR platforms, are explicitly excluded because they do not affect product quality or patient safety.

Once software is identified as in-scope, manufacturers must assess two key types of risk:

• Process risk: the potential consequences if the software fails in performing its role in production or quality operations. Could a malfunction disrupt a critical quality check, mismanage complaint handling, or allow a defect to pass unnoticed?
• Medical device risk: the degree to which such a software failure might ultimately impact the safety or effectiveness of the medical device itself, and by extension, patient health.

The guidance encourages companies to focus on identifying high-process-risk functions; those where failures could foreseeably compromise safety. For these functions, a more rigorous assurance effort is appropriate. Conversely, for functions with lower process risks, companies can justify lighter assurance activities. This tiered risk evaluation ensures that resources are focused where they matter most, without burdening less critical systems with unnecessary effort.

Perhaps the most significant evolution in this guidance is the shift from rigid validation exercises to flexible, risk-based assurance activities. In the past, the expectation was extensive scripted testing and documentation for virtually every system. The new framework acknowledges that different levels of risk demand different types of assurance.

For high-risk functions, formal, scripted testing and thorough evidence collection remain appropriate. These functions may directly affect device safety or critical quality outcomes, so robust verification is essential.

For lower-risk functions, however, the FDA now explicitly permits less formal approaches, such as unscripted testing, exploratory testing, or leveraging vendor-provided validation and audit records. The guidance also encourages the use of digital evidence, automated logs, audit trails, and system-generated records, rather than duplicating efforts with redundant paper documentation. This approach better reflects the way modern software is built, monitored, and maintained.

The FDA even outlines examples of practical methods: error-guessing, real-world scenario testing, continuous monitoring of system performance, and evaluation of vendor testing reports. By adopting these tools, manufacturers can generate meaningful assurance without unnecessary paperwork, reducing the validation bottleneck that often plagued new technology rollouts.

Software assurance doesn’t end after initial validation; systems evolve, and so must oversight. The FDA’s guidance highlights the importance of change control in production and quality software. When software is updated, manufacturers must evaluate whether the change introduces new risks. For changes that could potentially impact patient safety, additional assurance activities or even regulatory reporting may be required. In contrast, routine updates with minimal impact can be handled with streamlined internal processes.

Vendor management is another critical theme. Many production and quality systems are now delivered as cloud-based or third-party platforms, meaning manufacturers rely heavily on external suppliers. The FDA expects manufacturers to carefully evaluate vendors, including their validation documentation, quality certifications, audit results, and cybersecurity practices. By leveraging vendor evidence, companies can avoid duplicating testing and instead focus on verifying that risks are adequately managed. This makes supplier oversight an integral part of the assurance process.

This final guidance formally supersedes Section 6 of the FDA’s older General Principles of Software Validation. Compared to that earlier framework, the changes are substantial:

• A stronger emphasis on risk-based decision-making, ensuring that high-risk functions get more attention than low-risk ones.
• Explicit acceptance of unscripted and exploratory testing methods alongside traditional scripted tests.
• Recognition of vendor evidence and automated logs as valid and efficient assurance tools.
• A shift toward evaluating software feature by feature, rather than treating every system as a single, monolithic block.

Another important note: the FDA’s Quality Management System Regulation (QMSR), which aligns with ISO 13485, will take effect in February 2026. The agency has already signaled that this guidance will be updated again at that time to remain harmonized with international standards.

Medical device manufacturers should act quickly to adapt their practices to this new framework. Recommended steps include:

1. Catalog all in-scope software used in production and quality operations.

2. Classify features and functions by risk, assessing both process and medical device risks.

3. Match assurance activities to risk levels, reserving rigorous testing for high-risk functions and scaling down efforts for low-risk ones.

4. Leverage vendor documentation and automated system evidence to avoid redundant validation.

5. Strengthen supplier oversight, ensuring third-party vendors meet expectations for assurance and cybersecurity.

6. Refine change control practices so that software updates are evaluated proportionally to their impact.

By following these steps, manufacturers can align with FDA expectations while streamlining their own operations.

The FDA’s new Computer Software Assurance guidance represents a major cultural shift in regulatory thinking. It moves away from an era of exhaustive, one-size-fits-all validation and toward a modern, flexible, and risk-based approach. The emphasis is on focusing resources where they matter most: the functions that, if they fail, could jeopardize patient safety or product quality.

For the medical device industry, this is both a challenge and an opportunity. It challenges manufacturers to rethink old processes and embrace new methods of assurance. At the same time, it offers an opportunity to adopt digital tools more confidently, reduce unnecessary documentation, and ultimately improve efficiency without compromising safety.

This is not just a regulatory update; it’s a blueprint for smarter, leaner, and more innovative quality management in the medical device space.