The article describes the approach to be applied with respect to corrective actions to be taken in response to non-compliances identified.
Table of Contents
The Health Sciences Authority (HSA), Singapore’s regulatory agency in the sphere of healthcare products, has published a guidance document dedicated to Field Safety Corrective Actions (FSCA). The document provides an overview of the regulatory requirements set forth under the current framework, as well as recommendations to be considered by medical device manufacturers and other parties involved in operations with medical devices in order to ensure compliance thereto. The authority also reserves the right to make changes to the guidance and recommendations provided therein, should such changes be reasonably necessary to reflect corresponding changes to the underlying regulations. Furthermore, it is also stated that in case of any concerns, professional legal advice should be requested.
Recommendations provided in the guidance are based on the provisions of the Health Product Act (hereinafter – the “Act”), and Health Products (Medical Devices) Regulations 2010 (the “Regulations”), according to which FSCAs should be reported to the authority. Under the general rule, an FSCA is required when it becomes necessary for the product owner of the medical device to take action (including recall of the device) to eliminate, or reduce the risk of, the hazard identified; an FSCA may still be necessary even when the medical device is no longer on the market or has been withdrawn but could still possibly be in use (e.g., implants). With respect to recalls, the document refers to the respective guidance document dedicated to medical device recalls. Recommendations provided in the guidance should be considered by all the parties involved in operations with medical devices including registration, manufacturing, importation, and/or supply of medical devices in the country.
Terms and Definitions
First of all, the document provides definitions of the most important terms and concepts used in the context of Field Safety Corrective Actions including, inter alia, the following ones:
- Correction, which stands for an action to eliminate a detected nonconformity including the repair, modification, adjustment, relabelling, or inspection (including patient monitoring) of a device.
- Corrective and Preventive Action (CAPA) is defined as an action taken to address the identified root cause for the device problem or issue for which the FSCA was initiated. According to the guidance, this includes post-market surveillance, recalls, as well as corrective or preventive actions.
- Correction-in-progress device – the one which is affected by the FSCA and has not completed the CAPA intended by the product owner to wholly correct for the FSCA; i.e., devices having interim risk mitigation measures will be considered as a correction-in-progress device.
- Effectiveness check – verification checks conducted, which can include surveys of those affected by the FSCA (consignees) to verify they have received the FSCA information and are aware of any appropriate action to be taken and may include verification of the action taken.
- Field Safety Notice (FSN) stands for a communication sent out by a product owner or its representative to the device users in relation to an FSCA.
- Health Hazard Assessment (HHA) – the scientific characterization of the probability of occurrence and severity of known or potential adverse health effects resulting from exposure to hazards. As further explained by the HSA, the said process is comprised of the following consequent steps: hazard identification, hazard characterization, exposure assessment, and risk characterization.
Determining the Need for an FSCA
The document further describes the approach to be applied when determining the need for a Field Safety Corrective Action. Under the general rule, such a determination should be performed by the party responsible for a medical device (product owner).
As explained by the authority, the need for an FSCA arises in case of information about unacceptable risks received by the party responsible for a medical device. The authority may also request such actions to be taken with respect to a product for which the information about the unacceptable risk associated thereto becomes available to the authority. Usually, these risks are identified in the course of post-marketing surveillance and communicated in adverse events reports. Sometimes precautionary measures are to be taken in order to ensure public health protection by ceasing the availability of certain medical devices to customers by removing medical devices from the market or issuing a risk communication notifying the general public about the risks associated with the device.
Notification of FSCA
Should the Field Safety Corrective Action be related to a medical device that is manufactured or allowed for marketing and use in Singapore, the appropriate notification should be submitted to the HSA. Furthermore, the party responsible for a medical device should take all the actions required to ensure necessary measures are duly taken.
According to the diagram provided in the guidance, when determining the need for notification to be provided, a party responsible for a medical device should take into consideration the following factors:
- Has there been local manufacture of affected devices?
- Have the affected devices been supplied in Singapore?
- Are there unsupplied physical stock of affected devices in Singapore?
- Do affected devices currently have marketing authorization?
With respect to marketing authorization, the document refers to the respective guidance dedicated to medical device marketing authorization in accordance with the applicable regulatory requirements.
In summary, the present HSA guidance provides an overview of the regulatory requirements in the sphere of Field Safety and Corrective Actions as set forth under the current framework. The document describes the key concepts and decision-making flow to be followed by the parties responsible for medical devices intended to be marketed and used in Singapore.
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