All terms
Field Safety Corrective Action
Action taken to reduce a risk of serious deterioration in health associated with a device.
Reviewed by Christian Espinosa, Founder, Blue Goat CyberLast reviewed May 5, 2026
Definition
An FSCA is any action taken by a manufacturer to reduce the risk of a serious incident in relation to a device already placed on the market, including device modifications, exchange, return, destruction, or advice to users (FSN). What the regulation says
Under the EU Medical Device Regulation (MDR) 2017/745, manufacturers are required to implement Field Safety Corrective Actions (FSCAs) to mitigate risks associated with devices already on the market. The FDA, in 21 CFR Part 806, outlines similar manufacturer reporting requirements for corrections and removals, which can align with the concept of an FSCA. ISO 14971:2019, while not directly mandating FSCAs, provides a framework for risk management that informs decisions leading to such actions.What this means in practice
FSCAs are reported to Competent Authorities in the EU and may correspond to FDA recalls, depending on classification.Examples
- A manufacturer issues an FSCA to update the software of an infusion pump to correct a bug that could lead to incorrect dose delivery.
- An FSCA is initiated to replace a specific component in an implantable device after reports of premature degradation, potentially affecting patient safety.
- A Field Safety Notice is distributed to advise healthcare professionals on a revised cleaning protocol for a reusable surgical instrument to prevent cross-contamination.
Common pitfalls
- •A common pitfall is failing to promptly initiate an FSCA when new risk information emerges, potentially leading to more severe patient harm and regulatory penalties.
- •Manufacturers sometimes incorrectly assume that minor product updates do not require an FSCA, even if they address a potential safety concern.
- •Not all product changes or customer communications qualify as an FSCA, leading to confusion about reporting obligations.
- •Failure to adequately communicate the FSCA to all affected parties, including users and distributors, can undermine its effectiveness.
- •Inadequate documentation of the FSCA process and its outcomes can lead to compliance issues during audits.
Frequently asked questions
The primary goal of an FSCA is to proactively reduce the risk of serious incidents or harm to patients, users, or other persons associated with a medical device already in circulation.
Cross-references
See also
Related terms
Shared paths + categoryPost-Market
Medical Device Vigilance
Reporting and management of serious incidents and field safety corrective actions.
EU MDR Essentials · adjacentPost-Market Mastery · adjacent
Post-Market
Medical Device Recall
Removal or correction of a marketed device that violates FDA law.
Post-Market Mastery · adjacent
Post-Market
Periodic Safety Update Report(PSUR)
Periodic EU MDR/IVDR report summarizing post-market surveillance findings.
EU MDR EssentialsPost-Market Mastery
Regulatory
CE Mark
Mandatory European conformity mark for medical devices placed on the EU market.
EU MDR EssentialsIVDR Essentials
Regulatory
EU In Vitro Diagnostic Regulation(IVDR)
Regulation (EU) 2017/746 governing in vitro diagnostic medical devices in the EU.
EU MDR EssentialsIVDR Essentials
Regulatory
EUDAMED
European Database on Medical Devices.
EU MDR EssentialsIVDR Essentials
Latest in MedTech
Primary references
3 sourcesLink health: 3 verified· last checked 2026-06-20
MDCG·1FDA·2
- 1MDCG Vigilance GuidanceVerifiedMDCGhealth.ec.europa.eu
- 2FDA MAUDE DatabaseVerifiedFDAaccessdata.fda.gov
- 3FDA Recalls - Medical DevicesVerifiedFDAfda.gov
Inline markers like [1] jump to the matching reference above.