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Field Safety Corrective Actions (FSCAs) & Field Safety Notices

A Field Safety Corrective Action (FSCA) is any action taken by a registration holder to reduce a risk of death or serious injury associated with a device already on the market. FSCAs include:

  • Device recalls (physical removal from market or patients);
  • Device modifications or field corrections (e.g., software updates, replacement of components);
  • Changes to instructions for use or warnings; and
  • Enhanced monitoring or restriction of use.

A Field Safety Notice (Comunicado de Segurança) is the written communication sent to distributors, healthcare facilities and, where appropriate, patients to inform them of the FSCA and the actions they need to take.

Field Safety Notices must be in Portuguese, clearly describe the safety issue and required actions, and be sent via a method that can be tracked (email with confirmation, courier with receipt).

Official sources

Verify all information against official ANVISA sources before making regulatory decisions.