Should the manufacturer standardize the contents of the Field Safety Notice so it includes all the contents (Annex (B))? of the guidelines for corrective actions for safety warnings for medical devices and products?
Question
Should the manufacturer standardize the contents of the Field Safety Notice so it includes all the contents (Annex (B))? of the guidelines for corrective actions for safety warnings for medical devices and products?
Answer
The Annex specifies the requested information in the Field Safety Notice, other information may be added by the manufacturer, according to the type of the problem and the corrective or preventive actions to reduce or remove a risk.
