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Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices

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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?

In 1998 the questions were different:

Does the device software control a life supporting or life sustaining device?

Does the device software control the delivery of potentially harmful energy which could result in death or serious injury, such as radiation treatment systems, defibrillators, and so forth?

Does the device software control treatment delivery, such that an error or malfunction with the delivery could result in death or serious injury?

Does the device software provide diagnostic information on which treatment or therapy is based, such that if misapplied it could result in serious injury or death?

If yes, then the device may be of a "major" level of concern, especially in cases where diagnostic information would be misleading or inaccurate, or inappropriate therapy would be delivered. These situations may result in serious injury to the patient through an improper diagnosis of a serious medical condition or improper treatment.

A device may provide data for which it is unlikely that the clinician will exercise independent judgment. The following are examples of scenarios that might arise:

Major:  a radiation treatment system delivering potentially harmful radiation therapy without user knowledge; and

Moderate:  a system providing incorrect diagnostic information which is readily and easily detected and overridden based on patient demographics, symptoms, and other tests.

In the latter case, one in which clinical judgment would be exercised to override the information provided by a medical device (even in cases of incorrect data), the device would be considered one of lower level of concern.

Does the device software provide vital signs monitoring and alarms for potentially life threatening situations in which intervention is necessary?

If the answer is yes to any of the above questions, the following question should be answered:

Does the software directly affect the patient so that failures or latent design flaws could result in death or serious injury to the patient, or does it indirectly affect the patient such that incorrect or delayed information could result in death or serious injury to the patient?

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