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When an FSCA is Required

Definition (MedDO Art. 69)​

A Field Safety Corrective Action (FSCA) is any action taken by a manufacturer to reduce a risk of death or serious deterioration in the state of health associated with the use of a medical device that is already made available on the market. FSCAs include:

  • Device recall — return of a device to the manufacturer (or another party designated by the manufacturer)
  • Device modification — including modification in the field, device exchange, or device destruction
  • Device retrofit — a software or hardware update/upgrade to a device in use
  • Safety advisory — communication advising users of a risk and recommending precautionary measures
  • Restriction of use — limiting the intended use or the users of a device

When to Initiate an FSCA​

An FSCA must be initiated when the manufacturer determines that a device on the market presents a risk of death or serious deterioration in health. This determination arises from:

  • Analysis of a serious incident report
  • Trend analysis indicating an unacceptable increase in non-serious incidents
  • Design defect identified post-market
  • Manufacturing defect affecting a batch or production run
  • New clinical evidence indicating a previously unrecognised risk

Voluntary vs Regulatory-Ordered FSCA​

Most FSCAs are initiated voluntarily by the manufacturer. Swissmedic may order an FSCA if the manufacturer fails to act on a risk that Swissmedic has identified through market surveillance or vigilance reporting.

Official Sources​

Disclaimer

AI-assisted content for navigation only. Always verify against official Swissmedic and Fedlex sources. Not legal or regulatory advice.