Field Safety Notices (FSNs)
A Field Safety Notice (FSN) is a communication to customers and healthcare professionals about a device safety issue, issued alongside or preceding an FSCA.
Required FSN content (MFDS expectation)
- Product name, model, affected lot/batch numbers, UDI
- Description of the problem/hazard
- Risk assessment — potential consequences of the issue
- Recommended actions for healthcare facilities and/or patients
- Manufacturer/importer contact information
- Action required by the recipient (return, quarantine, modify, check)
Language requirement
FSNs distributed in Korea must be in Korean.
MFDS notification
A copy of the FSN must be submitted to MFDS at the time of distribution.