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Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices
Guidance Questions:
The new questions the FDA provides in establishing the Level of Concern is different from the flowchart provided in the 1998 guidance version. The new questions are more concise and provide a more definitive approach to determining the level of concern associated with your software.
In the new (2005) document the questions used to determine the level of concern are different:
If the answer to any one question below is Yes, the Level of Concern for the Software Device is likely to be Major.
Does the Software Device qualify as Blood Establishment Computer Software?
(Blood Establishment Computer Software is defined as software products intended for use in the manufacture of blood and blood components or for the maintenance of data that blood establishment personnel use in making decisions regarding the suitability of donors and the release of blood or blood components for transfusion or further manufacture.)
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?