Field Safety Corrective Actions (FSCAs)
Definition
A Field Safety Corrective Action (FSCA) is any action taken by a manufacturer to reduce the risk of death or serious deterioration in health associated with a device already placed on the market. FSCAs are broader than recalls and include:
| FSCA type | Description |
|---|---|
| Return/recall | Device retrieved from users/customers |
| Device modification/upgrade | Manufacturer corrects the device in the field |
| Software patch/update | Software fix distributed to users |
| Labelling update | Corrected labels or IFU issued |
| User notification/advisory | Users informed of risk and actions to take |
| Destruction in field | Device destroyed without return |
| Change in use/indication | Restrictions placed on use |
Field Safety Notice (FSN)
A Field Safety Notice is the written communication sent to affected customers describing the FSCA. It must:
- Clearly identify the affected device(s) and lot/serial numbers
- Describe the deficiency in plain language
- Explain the risk to patients or users
- Provide clear, specific instructions (stop using, return, modify, check for error)
- Include a Customer Response Form (or equivalent mechanism) to confirm receipt and action
- Be issued in English and French
Health Canada's role in FSCAs
For Class I and Class II recalls/FSCAs, Health Canada reviews the FSN before it is issued to ensure the content is accurate and the risk is appropriately communicated. Health Canada may request changes to the FSN before approval.
FSCA documentation
The manufacturer must maintain records of:
- The FSCA strategy and rationale
- The FSN and its distribution list
- Customer responses and effectiveness check results
- The final FSCA report submitted to Health Canada
Legislative source: Medical Devices Regulations, SOR/98-282, s 65; Health Canada Guidance on Medical Device Recalls