Medical Device Failure to Calibrate

Issue associated with the failure of the device to perform a self-calibration procedure or process designed to assure the accuracy and proper performance of the device. (Food and Drug Administration/CDISC)

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Medical Device Failure to Auto Stop

Issue associated with the inability of a device to turn itself off when the device is not in an operable condition. …

Medical Device Expiration Date Issue

Issue associated with the expiration date or shelf life of a product.

Medical Device Expiration Date Error

Issue associated with errors in identification of expiration date.

Medical Device Evaluation Results Terminology FDA CDRH

Terminology that represents results of evaluation used by the CDRH with respect to reporting Medical Device events.

Medical Device Evaluation Methods Terminology FDA CDRH

Terminology that represents methods of evaluation used by the CDRH with respect to reporting Medical Device events.

Medical Device Evaluation Conclusions Terminology FDA CDRH

Terminology that represents conclusions of an evaluation used by the CDRH with respect to reporting Medical Device events.