Skip to main content

FSCA Process

Step 1 — Internal FSCA Decision​

The manufacturer makes the internal decision to initiate an FSCA. Document the rationale, scope (affected devices, lot numbers, serial numbers), and the chosen corrective action type.

Step 2 — Swissmedic Notification​

The manufacturer or CH REP must notify Swissmedic before or simultaneously with the start of the FSCA. Notification is via the Swissmedic eVigilance portal and must include: description of the issue; devices affected (UDI, lot/serial numbers); corrective action planned; draft Field Safety Notice (FSN); timeline for implementation.

Step 3 — Field Safety Notice (FSN)​

The FSN is the written communication sent to all customers affected by the FSCA. It must:

  • Be clearly titled "URGENT FIELD SAFETY NOTICE" or equivalent
  • Describe the issue and the risk to patients/users
  • Clearly identify the affected devices (UDI, lot numbers, model names)
  • Specify the required action for the customer (e.g. stop use, return, retrofit, advisory)
  • Include contact details for questions and for returning devices (if applicable)
  • Be submitted to Swissmedic before or simultaneously with dispatch to customers
  • Be in German, French, and Italian for Swiss customers

Step 4 — Customer Notification and Implementation​

Send the FSN to all identified customers (hospitals, distributors, healthcare professionals). Maintain a record of all notifications sent and acknowledgements received. Implement the corrective action (device return, retrofit, etc.).

Step 5 — Effectiveness Check​

After implementation, conduct an effectiveness check to confirm the corrective action has been received and acted upon by customers. Document the results and report to Swissmedic in the follow-up report.

Official Sources​

Disclaimer

AI-assisted content for navigation only. Always verify against official Swissmedic and Fedlex sources. Not legal or regulatory advice.