"The documentation that we recommend you include in a premarket submission generally
depends on the device’s Level of Concern. For the purposes of this guidance document, Level
of Concern refers to an estimate of the severity of injury that a device could permit or inflict,
either directly or indirectly, on a patient or operator as a result of device failures, design flaws,
Contains Nonbinding Recommendations
5
or simply by virtue of employing the device for its intended use. We recommend that you
describe the role of the software in causing, controlling, and/or mitigating hazards that could
result in injury to the patient or the operator, because this is also a factor in determining the
appropriate Level of Concern for your device.
The extent of documentation that we recommend you submit for your Software Device is
proportional to the Level of Concern associated with the device. Level of Concern is defined
only for use in this context and is not related to device classification (Class I, II or III) or to
hazard or risk analysis per se."

Can you please explain the last part, "The extent of documentation that we recommend you submit for your Software Device is
proportional to the Level of Concern associated with the device. Level of Concern is defined
only for use in this context and is not related to device classification (Class I, II or III) or to
hazard or risk analysis per se.", i get a bit confused when per se is used.

Sincerely,
Ross