About the Author
Proxima CRO Team
Isabella Schmitt, MBA, RAC
Director of Regulatory Affairs
Ms. Schmitt has also served in additional regulatory affairs and clinical research roles in which she contributed to multiple regulatory submissions and clinical affairs projects across a wide range of indications.

For Moderate and Major Level of Concern Software Devices, the submission should include a list of all unresolved software anomalies. For each anomaly, FDA recommends that you indicate the:

  • problem
  • impact on device performance
  • any plans or time frames for correcting the problem (where appropriate)

FDA recommends that you annotate each item with an explanation of the impact of the anomaly on device safety or effectiveness, including operator usage and human factors issues. Typically, this list can be generated as an output of a change control board or similar mechanism for evaluation and disposition of unresolved software anomalies. It is recommended that you communicate this list to the end user as appropriate to assist in the proper operation of the device. In all instances where it is practical to do so, you should also include any mitigations or possible work-arounds for unresolved anomalies; this recommendation applies to Blood Establishment Computer Software in particular.

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