FDA recommends that you determine the Level of Concern before any mitigation of relevant hazards. In other words, the Level of Concern should be driven by the hazard analysis in the absence of mitigations, regardless of the effects of the mitigations on the individual hazards.

FDA recommends that you state in your submission the Level of Concern you have determined for your Software Device. It may be Major, Moderate or Minor as defined below. It is also recommended that you describe how you arrived at that Level of Concern. The Level of Concern is based on how the operation of the software associated with device function affects the patient or operator. The effect may be direct or indirect.

Major

FDA believes the level of concern is Major if a failure or latent flaw could directly result in death or serious injury to the patient or operator. The level of concern is also Major if a failure or latent flaw could indirectly result in death or serious injury of the patient or operator through incorrect or delayed information or through the action of a care provider.

Moderate

FDA believes the level of concern is Moderate if a failure or latent design flaw could directly result in minor injury to the patient or operator. The level of concern is also Moderate if a failure or latent flaw could indirectly result in minor injury to the patient or operator through incorrect or delayed information or through the action of a care provider.

Minor

FDA believes the level of concern is Minor if failures or latent design flaws are unlikely to cause any injury to the patient or operator.  

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