Field Safety Corrective Actions (FSCA)
What is an FSCA?
A Field Safety Corrective Action (FSCA) is any action taken by a manufacturer to reduce a risk of death or serious injury associated with the use of a medical device that has already been placed on the market. FSCAs may be initiated at the manufacturer's discretion or required by MDA.
FSCAs include:
| Type | Description |
|---|---|
| Device recall | Removal of devices from the market or from users/patients |
| Device modification | Modification of a device in the field (software update, hardware modification) |
| Exchange | Replacement of a device with a different version |
| Destruction | Destruction of devices that cannot be recalled for use |
| Labelling update | Revision of labelling or IFU to add safety information or warnings |
| User advisory | Communication to users about precautions or restrictions on use |
When Must an FSCA Be Initiated?
An FSCA must be initiated when:
- The device has a defect or characteristic that could cause or contribute to serious injury or death
- The device was manufactured in a way that does not conform to specifications and this creates a safety risk
- New safety information indicates that the benefit-risk profile is no longer acceptable
- MDA or another regulatory authority orders a recall
Field Safety Notices (FSN)
A Field Safety Notice (FSN) is the communication sent to affected customers (hospitals, distributors, users) informing them of the FSCA and the action required. The FSN is a mandatory accompaniment to any FSCA.
FSN Contents
- Unique reference number
- Device identification (name, DRN, lot/serial numbers affected)
- Description of the problem and associated risks
- Description of the action required and how to carry it out
- Instructions for returning, modifying, or disposing of affected devices
- Contact details for queries
- Response/acknowledgement form (for recalls)
Notifying MDA
The manufacturer/LAR must notify MDA of any FSCA before or simultaneously with informing customers, unless an immediate action is required for safety, in which case MDA is notified as soon as reasonably practicable.
Notification timeline: Within 10 working days of the decision to initiate the FSCA (non-urgent) or immediately for urgent safety actions.
Notification method: Via the MyMDA portal → Post-Market → FSCA Notification.
FSCA Notification to MDA Must Include
- Summary of the safety issue
- Scope of affected devices (model, batch/lot numbers, quantities)
- Proposed FSCA action
- Draft FSN for MDA review (MDA may require modifications before release)
- Timeline for customer notification and action completion
- Regular progress reports until FSCA is complete
MDA's Role in FSCAs
MDA may:
- Review and approve the FSN before it is issued to customers
- Require additional or modified FSCA actions
- Issue a public safety alert on the MDA website
- Coordinate with other ASEAN regulators via the ASEAN AMDD information exchange
International FSCA Coordination
If an FSCA is initiated in another country (e.g. US, EU, Australia), the Malaysian LAR must assess whether Malaysian-market devices are affected and implement the FSCA in Malaysia if they are. The LAR cannot wait for the manufacturer to instruct them — they have an independent obligation to act.
Maintain an up-to-date distribution list with batch/lot traceability to all direct customers. This is essential for rapid, targeted FSCAs. MDA will ask you to demonstrate the scope of notification during FSCA reviews.