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Major Changes in the new 2023 FDA Guidance on Device Software Submissions

Updated: Feb 15


The U.S. Food and Drug Administration (FDA) has released a new guidance document on the content of premarket submissions for device software functions. The guidance, titled "Content of Premarket Submissions for Device Software Functions," replaces the FDA's 2005 guidance on the same topic.

The U.S. Food and Drug Administration (FDA) has released a new guidance document on the content of premarket submissions for device software functions. The guidance, titled "Content of Premarket Submissions for Device Software Functions," replaces the FDA's 2005 guidance on the same topic.


The new guidance reflects the FDA's commitment to ensuring the safety and effectiveness of medical device software. It includes three major changes:

  1. A risk-based approach to documentation: The new guidance takes a risk-based approach to documentation, which means that the more complex and risky the software, the more documentation will be required. This change is intended to make the premarket review process more efficient and effective by focusing the FDA's resources on the most complex and risky software. Under the new guidance, the FDA will categorize software into two levels of risk: Basic and Enhanced. Basic Documentation will be required for software that is low-risk, while Enhanced Documentation will be required for software that is high-risk. The FDA will use a variety of factors to determine the risk level of software, including the intended use of the device, the complexity of the software, and the potential for harm if the software fails.

  2. A focus on verification and validation (V&V): The new guidance places a greater emphasis on V&V activities, which are the processes of ensuring that software meets its requirements and is free of errors. This change is intended to help ensure the safety and effectiveness of software by requiring manufacturers to take a more rigorous approach to software development. The new guidance provides detailed guidance on how to conduct V&V activities.

  3. Recognition of modern development practices: The new guidance recognizes modern development practices, such as agile development and continuous integration and delivery. Agile development is a software development methodology that emphasizes iterative development and continuous feedback. Continuous integration and delivery is a software development practice that automates the process of building, testing, and deploying software. The FDA believes that these modern development practices can help to improve the quality and safety of software. The new guidance provides guidance on how to use these practices in the development of medical device software.


The new FDA Guidance Content of Premarket Submissions for Device Software Functions is a significant update that reflects the agency's commitment to ensuring the safety and effectiveness of medical device software. Manufacturers of medical devices with software functions should carefully review the new guidance and make any necessary changes to their development and documentation processes.


If you have any questions about the new FDA Guidance Content of Premarket Submissions for Device Software Functions, please contact us. We are here to help you understand the new requirements and to support you in implementing them.


Download a copy of the FDA Guidance in our BioBoston Consulting's LinkedIn page.

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