Skip to main content

Field Safety Notices (FSNs)

A Field Safety Notice (FSN) is a formal communication from a manufacturer or importer to customers, healthcare professionals, and healthcare facilities about a device safety issue, issued alongside or preceding a Field Safety Corrective Action (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.

MFDS notification​

"Timing: FSNs must be distributed without delay upon identification of a safety issue. MFDS notification should occur simultaneously with or before distribution to customers and healthcare professionals."