The Food and Drug Administration (FDA) has recently released a draft guidance that signals a significant shift in their approach to software used in the production and quality systems of medical devices. This new guidance, titled “Computer Software Assurance for Production and Quality System Software”, emphasizes a risk-based, lifecycle approach to software assurance, moving away from a single validation focus. This blog post will delve into the details of this new guidance, highlighting its key aspects and implications for the medical device industry.
The Shift from Validation to Assurance
Traditionally, the FDA’s approach to software in the medical device industry has focused on validation – proving that the software works as intended. However, the new draft guidance shifts the focus towards assurance – establishing confidence in the software throughout its entire lifecycle.
This shift is more than just semantics. While validation is a crucial step in establishing confidence in the software, assurance is a broader, ongoing process. Assurance is about building confidence in the software from design and development, through validation, and into ongoing maintenance and updates. It’s a more holistic, continuous approach that includes but is not limited to validation.
For example, consider a software used for automating the production process of a medical device. Under the traditional approach, the software would be validated to ensure it works as intended before it’s put into use. Under the new approach, the software would still be validated, but there would also be ongoing assurance activities to maintain and demonstrate software quality throughout its lifecycle.
Risk-Based Approach to Software Assurance
A key aspect of the new guidance is the emphasis on a risk-based approach to software assurance. This means that the level of rigor applied to software assurance activities should be commensurate with the level of risk associated with the software.
The risk-based approach allows for flexibility in the level of rigor applied to software assurance activities. It recognizes that not all software carries the same level of risk and allows for a more efficient allocation of resources towards higher-risk software.
The risk assessment process involves considering factors such as the severity of potential harm, the probability of occurrence, the ability to detect a failure, and the risk control measures in place. For instance, software that controls a critical manufacturing process for a high-risk medical device would likely be considered high risk and would therefore require more rigorous assurance activities.
Implications for the Medical Device Industry
The shift towards a risk-based, lifecycle approach to software assurance has significant implications for the medical device industry. It requires a change in mindset from viewing software validation as a one-time event to viewing software assurance as an ongoing process.
This shift can lead to improved software quality and reliability, which in turn can lead to improved patient safety and product quality. It can also lead to more efficient use of resources, as resources can be allocated based on the level of risk associated with the software.
The FDA’s new draft guidance on “Computer Software Assurance for Production and Quality System Software” represents a significant shift in their approach to software used in the production and quality systems of medical devices. By emphasizing a risk-based, lifecycle approach to software assurance, the FDA is encouraging the medical device industry to take a more holistic, continuous approach to ensuring software quality. While the guidance is still in draft form and is not for implementation, it provides valuable insights into the FDA’s current thinking on this important topic.
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Disclaimer
Please note that the information provided in this blog post is based on the FDA’s draft guidance on “Computer Software Assurance for Production and Quality System Software” as of the date of publication. The FDA received a total of 390 comments on this draft guidance during the public comment period. The final guidance may incorporate feedback from these comments and may differ from the draft guidance.
Refer to: https://www.regulations.gov/docket/FDA-2022-D-0795
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