FSCA Risk Management and Corrective Actions
Risk assessment before an FSCA
Before deciding whether an FSCA is required, the registrant or manufacturer should conduct a risk assessment in accordance with ISO 14971 (Risk Management for Medical Devices) to:
- Identify the hazard and the hazardous situation;
- Estimate the probability of harm occurring;
- Estimate the severity of harm if it occurs;
- Assess the risk (probability × severity);
- Determine whether the risk is acceptable given the device's intended benefits;
- If unacceptable, identify the corrective action needed to reduce the risk.
HSA has published guidance on the risk management process for FSCAs:
hsa.gov.sg/medical-devices/field-safety-corrective-action/corrective-actions
Types of corrective action
| Action type | When appropriate |
|---|---|
| Device recall | Device poses a risk that cannot be mitigated in the field; physical retrieval and disposal or modification is required |
| Device modification/upgrade | A field modification (e.g. software patch, hardware fix) can reduce the risk to acceptable levels |
| Advice on use | Risk can be mitigated by modifying how the device is used; updated instructions or warnings are distributed |
| Labelling update | Missing or incorrect information in the IFU or label is contributing to risk; revised documents are issued |
| User training | Risk arises from incorrect use; training programme is implemented |
Post-FSCA obligations
After completing an FSCA, the registrant must:
- Submit a final report to HSA confirming the FSCA is complete;
- Provide evidence that all affected devices in Singapore have been accounted for;
- Update the registered device's technical documentation to reflect any design or labelling changes made as part of the FSCA;
- Submit a change notification for any changes to the registered device arising from the FSCA.