Field Safety Notice Customer Reply Form

Download a free template (MS Word)

Manufacturers must inform affected users of a field safety corrective action (FSCA) through a field safety notice (FSN), which is also sent to relevant national regulatory authorities and WHO. This form allows manufacturers to ensure that the FSN is distributed to all affected individuals and to keep track of FSN receipt confirmations.

This MDR Field Safety Notice Customer Reply Form helps manufacturers to:

• Reduce the specified risk of medical device usage
• Strengthen the communication with users
• Build a strong reputation among their audience