Field Safety Corrective Actions — When to Report
What is an FSCA?
A Field Safety Corrective Action (FSCA) is an action taken by a manufacturer or its authorised representative to reduce a risk of death or serious deterioration in health associated with a medical device that has already been placed on the market. An FSCA may involve:
- Recall: return of the device to the manufacturer or distributor;
- Device modification: field upgrade or modification to make the device safer;
- Advice on use: distribution of instructions to users to change the way the device is used;
- User training: additional training for healthcare professionals or users;
- Labelling update: issuing revised or corrected labelling or IFU.
When must an FSCA be reported to HSA?
An FSCA must be reported to HSA before or at the time it is initiated in Singapore (or contemporaneously with the global action where a global FSCA is being conducted).
The obligation to report arises when:
- A device in the Singapore market poses a risk of death or serious deterioration in health to patients, users, or other persons; and
- Corrective action is being taken (or should be taken) to reduce that risk.
This applies to FSCAs initiated by the overseas manufacturer globally, where the Singapore registrant or dealer is aware that the action affects devices supplied in Singapore.
Company-initiated vs HSA-directed FSCAs
Company-initiated: The registrant or manufacturer identifies the safety issue and initiates the FSCA voluntarily. This is the expected pathway for a well-functioning post-market system.
HSA-directed: HSA may direct a registrant or dealer to initiate an FSCA where HSA identifies a safety risk through its own post-market monitoring activities and the company has not already acted.