A communication to customers and/or users sent out by a manufacturer or its representative in relation to a Field Safety Corrective Action
Field Safety Notice
The FSN may include; permanent or temporary changes to the labelling or instructions for use, software upgrades including those carried out by remote access, modification to the clinical management of patients to address a risk of serious deterioration in state of health or death related specifically to the characteristics of the device. For example:
- for implantable devices it is often clinically unjustifiable to explant the device. Corrective action taking the form of special patient follow-up, irrespective of whether any affected un-implanted devices remain available for return, constitutes FSCA.
- for any diagnostic device (e.g. IVD, imaging equipment or devices) the recall of patients for retesting or the retest or review of previous results constitutes FSCA.
- advice relating to a change in the way the device is used e.g. IVD manufacturer advises revised quality control procedure
- use of third party controls or more frequent calibration or modification of control values for IVDs.