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Field Safety Corrective Actions (FSCAs)

What is an FSCA?​

A Field Safety Corrective Action (FSCA) is any action taken by the manufacturer to reduce the risk of serious harm from a medical device that has already been placed on the market. FSCAs include:

  • Device recall (return of devices from users or market)
  • Device modification or upgrade (software update, hardware modification)
  • Destruction of devices
  • Advice from manufacturer on how to use the device more safely

When is an FSCA required?​

An FSCA is required when the manufacturer identifies a device-related risk that could cause serious harm to patients or users and that risk requires action on devices already distributed. The threshold aligns with the IMDRF FSCA definition.

Field Safety Notices (FSNs)​

When an FSCA is initiated, the manufacturer (via the AR) must issue a Field Safety Notice (FSN) to all affected users, healthcare facilities, distributors, and importers in Saudi Arabia. FSNs must be provided in both Arabic and English for the Saudi market — an important Saudi-specific requirement.

The FSN must:

  • Clearly identify the affected device(s) (by name, model, lot numbers)
  • Describe the problem and the risk
  • Provide the required action for recipients
  • Include AR and manufacturer contact details

SFDA notification​

The AR must notify the SFDA of any FSCA initiated for devices registered in Saudi Arabia, regardless of whether the action was initiated globally or only locally. Notification is submitted via GHAD.

Recall classification​

The SFDA may classify recalls based on the level of risk:

  • Class I recall — serious health hazard or risk of death
  • Class II recall — temporary or reversible health consequence
  • Class III recall — unlikely to cause adverse health consequence but recall is warranted

SFDA-initiated safety actions​

The SFDA may independently initiate a safety action — including mandatory recall — where it identifies a device safety risk through market surveillance, NCMDR reports, or information from foreign regulatory authorities.

Further reading​