The FDA recommends that you assess the Level of Concern before mitigating any hazard; that is, you should assess your software device against the following questions as though you have not implemented hazard mitigations.
If the answer to any question is No, continue on to the next question. In all cases, it is recommended that you assess the Level of Concern within the context of the worst possible, reasonably foreseeable, clinical consequences of failure of the Software Device.
Major Level of Concern
- Does the software device qualify as Blood Establishment Computer Software?
- Is the Software Device intended to be used in combination with a drug or biologic?
- Is the Software Device an accessory to a medical device that has a major level of concern?
- Prior to mitigation of hazards, could a failure of the Software Device result in death or serious injury, either to a patient or to a user of the device? Examples of this include the following:
- Does the Software Device control a life supporting or life sustaining function?
- Does the Software Device control the delivery of potentially harmful energy that could result in death or serious injury, such as radiation treatment systems, defibrillators, and ablation generators?
- Does the Software Device control the delivery of treatment or therapy such that an error or malfunction could result in death or serious injury?
- Does the Software Device provide diagnostic information that directly drives a decision regarding treatment or therapy, such that if misapplied it could result in serious injury or death?
- Does the Software Device provide vital signs monitoring and alarms for potentially life threatening situations in which medical intervention is necessary?
Moderate Level of Concern
- Is the Software Device an accessory to a medical device that has a Moderate Level of Concern?
- Prior to mitigation of hazards, could a failure of the Software Device result in Minor Injury, either to a patient or to a user of the device?
- Could a malfunction of, or a latent design flaw in, the Software Device lead to an erroneous diagnosis or a delay in delivery of appropriate medical care that would likely lead to Minor Injury?
If the answers to all of the questions above are No, the Level of Concern is Minor.