USA: FDA Updates Off-The-Shelf Software Guidance

FDA released updated guidance for off-the-shelf (OTS) software on 11 July 2023, supplanting the previous guidance updated in 2019.

Prior to 2019, the guidance centered on hazard analysis to decide if the software was safe to use by relying on the FDA's comprehension of how the OTS software was implemented into the products. Besides, the guidance also tried identifying various potential levels of risks they might be posed and including a decision tree for the risk evaluation.

However, now FDA has exterminated the hazard analysis approach and replaced it with an implementation of OTS software risk assessment with different levels of documentation. FDA also required sponsors to attach together the risk management file and plan. All the possible risks associated with the OTS software used must be documented in the file.

The requirement of the risk management file and the plan is applicable for both the Basic and Enhanced documentation level. Besides, sponsors are also required to include all listed below in the documentation:

• test plan

• test results as verification and validation

• testing activities performed by the OTS software developer and sponsors

FDA revises the updates as a reflective approach to reduce the burdens for all medical device sponsors to provide information to support a premarket submission.

Source: Food and Drug Administration (FDA)