The European Commission has posted new templates for a Field Safety Notice (FSN), for customer and distributor/importer reply forms as well as a Frequently Asked Questions (FAQ) on how to fill in the FSN on their website.
The new Field Safety Notice (FSN) template is significantly more elaborate. It contains more detail to allow easy and rapid identification, by the healthcare professional to whom the FSN is addressed, of the device to which the FSN applies, including a field to add the UDI-DI. The section in which the reason for the Field Safety Corrective Action (FSCA), which triggered the release of the FSN is to be addressed, now also requires greater detail. Particulars will have to be provided regarding the risk assessment performed and information such as probability of the issue arising and the predicted risk to patients/users is to be added.
The FAQ on how to fill in the FSN can provide guidance on how to use the FSN template and what type of information is to be added in each section.
The customer and distributor/importer reply forms offer a highly detailed example of the type of documented feedback is to be obtained as a response to an FSN.
What does this mean to you?
The FSN form and customer and distributor/importer reply forms are not mandatory to use as they are not defined within the Directives or new regulations. Nevertheless, as stated in the FAQ, industry is strongly encouraged to use these forms whenever possible in the interests of consistency to help the user.
Subscribe to Qarad’s newsflash to receive Regulatory updates.
