Types of Field Safety Corrective Actions for Medical Devices in Singapore

1. Overview

Field Safety Corrective Action (FSCA) refers to any corrective measure taken by the manufacturer to reduce the risk of using a medical device that has already been placed on the market. These actions are required when the device presents an unacceptable risk or fails to meet performance claims or intended purpose. Source: https://www.hsa.gov.sg/medical-devices/field-safety-corrective-action/corrective-actions

2. Common Types of FSCAs

Manufacturers may initiate the following FSCAs:

• Recall — Physical removal of affected devices from the market or from use by customers due to safety concerns.
• Field Safety Notice (FSN) — Written communication to users providing information about the risk and recommended actions without requiring device return.
• Design modification — Permanent changes to the device design to eliminate or reduce the identified risk.
• Software update — Release of updated software/firmware to correct defects or improve safety.
• Labelling or instructions change — Updates to warnings, contraindications, user manuals, or other labelling to improve safe use.
• Advice to users — Specific instructions or recommendations on how to use, maintain, or monitor the device to mitigate risk.

Source: https://www.hsa.gov.sg/medical-devices/field-safety-corrective-action/corrective-actions

3. When FSCA is Required

An FSCA is necessary when:

• The device presents an unacceptable risk to patients, users, or others.
• The device does not conform to its performance claims or intended purpose.
• Corrective measures are needed to reduce risk to an acceptable level.

The decision to initiate an FSCA is the responsibility of the manufacturer based on risk assessment. Source: https://www.hsa.gov.sg/medical-devices/field-safety-corrective-action/corrective-actions

4. Manufacturer Responsibilities

• Conduct a thorough risk assessment to determine the need for FSCA.
• Implement the chosen corrective action effectively.
• Communicate clearly with users through FSN or other means.
• Monitor the effectiveness of the FSCA and report progress to HSA as required.
• Maintain records of the FSCA process and outcomes.

Source: https://www.hsa.gov.sg/medical-devices/field-safety-corrective-action/corrective-actions

5. Reporting to HSA

All FSCAs affecting devices in Singapore must be reported to HSA within 2 working days of initiation. The report must include the type of FSCA, reason, affected devices, and the FSN. Source: https://www.hsa.gov.sg/medical-devices/field-safety-corrective-action/corrective-actions

6. Important Notes

• FSCAs may be initiated voluntarily by the manufacturer or as directed by regulatory authorities.
• Overseas manufacturers must ensure FSCAs are implemented and reported for devices supplied in Singapore.
• Failure to take appropriate FSCA or report may result in regulatory action.
• Last updated: 31 Dec 2018. Source: https://www.hsa.gov.sg/medical-devices/field-safety-corrective-action/corrective-actions

7. Related Guidance

Refer to the complete Field Safety Corrective Action guidance for detailed examples, reporting formats, and follow-up requirements. Source: https://www.hsa.gov.sg/medical-devices/field-safety-corrective-action/corrective-actions