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Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices
The FDA recently updated their guidance document for the content of premarket submissions for software contained in medical devices. The changes were substantial in content.
Major Differences
Definition of Level of Concern
2005
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, 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.
1998
FDA/CDRH uses the term "level of concern" as an estimate of the severity of injury that a device could permit or inflict (directly or indirectly) on a patient or operator as a result of latent failures, design flaws, or using the medical device software. The extent of the premarket review process pertaining to software products is proportional to the level of concern. Therefore, it is important to clarify the role of the software in causing, controlling, and/or mitigating hazards which could result in injury to the patient or the operator.
The 2005 guidance distinguishes the use of the device according to it’s Intended Use (as opposed to what can also be executed in an off-label manner).