Several months ago, Singapore’s Heath Science Authority (HSA) approved a revised edition of its corrective action policies for medical devices. It stated that a product may need to undergo field safety corrective action (FSCA) if product complaints and adverse incidents indicate that the device poses health risks to patients.
There are two FSCA categories. The product can be recalled and must be permanently disposed of or quarantined, or it can undergo “other corrective actions.” “Other corrective actions” refer to corrections limited to labeling and corrections not limited to labeling. With “corrections limited to labeling,” the producer may continue to supply the device as long as there is a field safety notice (FSN) supplementing the device. “Corrections not limited to labeling” is separated into “correction-in-progress” and “corrected” devices. “Correction-in-progress” devices may resume sales if the dealer, product owner, and relevant authorities all agree there are significantly lower risks associated with the new device. “Corrected” devices may also resume sales, but are subject to regulatory requirements. A full correction declaration must accompany the device upon its completion.