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Field Safety Corrective Action (FSCA)

Types of FSCA in Japan​

A Field Safety Corrective Action (FSCA) is any action taken by the MAH to reduce a risk associated with a device already on the market. FSCAs include:

  • Physical recall — removing affected devices from use and returning them to the MAH
  • Product correction — modifying, adjusting, or reworking affected devices in the field (without requiring return)
  • Product labelling change — issuing corrected labelling or updated IFU to all users
  • Software upgrade — distributing a mandatory software patch or update to address a safety issue
  • Customer advisory — providing healthcare professionals with safety information that changes how the device should be used, without physical recall

Planning an FSCA​

An effective FSCA plan includes:

  1. Scope definition — which specific devices (lot numbers, serial numbers, date ranges) are affected
  2. Risk assessment — confirming the risk level justifies the action (MHLW notification required for all FSCAs with a safety basis)
  3. Customer identification — identifying all customers who received affected units using distribution records
  4. Communication strategy — Field Safety Notice (FSN) preparation; delivery method; follow-up for non-responders
  5. Logistics — how units will be returned, quarantined, or corrected; replacement stock
  6. Timeline — how quickly must the FSCA be completed given the risk level

Effectiveness checks​

The MAH must establish a process to verify that the FSCA has been effective — that affected units have been recovered, corrected, or that safety information has reached all relevant users. Effectiveness is assessed by:

  • Tracking response rates from customers (percentage of units recovered or corrected)
  • Following up with non-responding customers
  • Confirming no new incidents involving non-recalled units

MHLW may set specific effectiveness targets for significant recalls.