The draft guidance is intended to provide information regarding the recommended documentation to include in premarket submissions for the FDA to evaluate the safety and effectiveness of device software functions. The proposed recommendations in this draft guidance document pertain to device software functions, including both software in a medical device (SiMD) and software as a medical device (SaMD), and describe a subset of information that would be typically generated and documented during software design, development, verification and validation.
 

Documentation Level:

The recommended documentation for a premarket submission depends on the device’s risk to a patient, a user of a device, or others in the environment of use. FDA intends to consider four risk-based factors to help determine the device’s Documentation Level, which is either Basic or Enhanced. The purpose of the Documentation Level is to help identify the minimum amount of information that would support a premarket submission that includes device software functions. The Documentation Level is based on the device’s intended use.  Evidence relevant to intended use may include the design of the device. Notably, the Documentation Level is determined by the intended use of the device as a whole—not the individual device function(s).

Basic Documentation should be provided for any premarket submission that includes device software functions where Enhanced Documentation does not apply. Enhanced documentation should be provided for any premarket submission that includes device software functions.
 

Recommended Documentation:

This recommended information should demonstrate that practices were employed resulting in traceability for device software functions and demonstrate planning, requirements, risk assessment, design reviews, change management, testing plans and results, and other aspects of good software engineering for device software functions, to help inform a regulatory decision on whether the software is appropriately designed, verified, and validated.
 

Documentation Level Evaluation:

A statement indicating the Documentation Level for the device and a description of the rationale for such Documentation Level, as appropriate.
 

Software Description:

An overview of operationally significant software features, including images, flow charts, and state diagrams as needed to adequately explain the software functionality should be provided.  If the premarket submission is for a modified device, the document number of the previous submission and highlight pertinent software changes since the last FDA approval or clearance.  Consider and provide information to address the questions below when preparing the software description. However, FDA recognizes that these questions and examples may not capture all the unique aspects of a device software function and encourages the inclusion of additional information that will streamline or further FDA’s understanding of the device’s functionality to facilitate the review of a submission.

If the device is a multiple function device product and includes software function(s) that are considered “other functions,” as that term is used in the guidance Multiple Function Device Product: Policy and Considerations, the recommendations described in the aforementioned guidance should be considered when preparing the software description information.