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USFDA Guidance: Content of Premarket Submissions for Device Software Functions

Last Wednesday (14 June 2023) the United States Food & Drug Administration's Center for Devices and Radiological Health, Center for Biologics Evaluation and Research, and Center for Drug Evaluation and Research released an updated guidance on "Content of Premarket Submissions for Device Software Functions".

Device Software Function - Software function that meets the device defined in section 201(h) of the FD&C Act.

The term “function” is a distinct purpose of the product, which could be the intended use or a subset of the intended use of the product.

The purpose of this guidance is to provide information regarding the recommended documentation for premarket submissions that will help the FDA evaluate device software functions, which are software functions that meet the definition of a device under section 201(h) of the FD&C Act.

This guidance is intended to facilitate the FDA's premarket review of software products and describes the information that would typically be generated and documented during software development, verification, and validation.

This guidance recommends the information to provide in a premarket submission that includes a device software function(s) and Device software functions subject to specific special controls may require additional software-related documentation in a premarket submission.

Click this LINK to know more about the Software Requirements Specification (SRS), Software Design Specification (SDS), etc.


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