SFDA Guidance on Field Safety Corrective Actions

Regulatory Background

The present SFDA guidance is intended to provide additional information and recommendations regarding field safety corrective actions (FSCA) to medical device manufacturers, their authorized representatives, and the importers placing devices on the market under the simplified procedure for low-risk devices

As it is indicated in the guidance, field safety corrective actions fall under the scope of the “Medical Devices Interim Regulation”, which is the main legislative act regulating the Field Safety Notices and other special actions to be taken by the responsible parties to ensure the highest level of public health protection.

Stages of Field Safety Corrective Actions

The SFDA guidance also describes in detail all stages of the procedures related to the FSCA. According to the document, it could be divided into the following stages:

1.     Reporting the FSCA to the SFDA or receiving the appropriate request (inquiry) from the authority,
2.     Notifying the users affected by the FSCA,
3.     Corrective Action Plan,
4.     Implementing Corrective Actions,
5.     Closure.

Reporting the FSCA to the SFDA

According to the SFDA guidance, the FSCA should be reported in case if they are related to the medical devices duly marketed on Saudi Arabia`s market or imported to the country.

The document outlines the following reporting rules:

• The manufacturer shall notify the SFDA on any field safety corrective action taken directly (or through the authorized representative or importer – in the case of a foreign manufacturer) by submitting the New Device FSN form using the website for the National Center for Medical Devices Reporting (NCMDR).
• The authority is also entitled to require the manufacturer to provide additional information, and the manufacturer shall provide such information requested by the SFDA without undue delay.
• All parties involved in the distribution of medical devices, including importers and authorized representatives of foreign manufacturers, shall establish an appropriate tracking system allowing them to collect and store data regarding all medical devices they have placed on the market.
• When filing a notification via the NCMDR website, the applicant shall provide all mandatory information and accompany the notification with the Field Safety Notice letter issued by the manufacturer in accordance with the template provided by the SFDA.

As it is explicitly stated in the SFDA guidance, the medical device manufacturer, its authorized representative, or importer shall inform the regulating authority about the field safety corrective actions taken within two business days from issuing the appropriate decision. Later it would be also necessary to provide the Corrective Action plan.  It is also important to mention that in case if the planned FSCA is not related to the medical devices marketed in Saudi Arabia, other procedures should be applied.

Field Safety Notices

On the second stage, the entity responsible for medical devices shall duly notify the affected users by providing them with the Field Safety Notice (FSN) letter. In particular, it is necessary to inform users of the device about the identified issue, associated risks, and specific actions to be taken to mitigate such risks.

According to the position of the SFDA, the following ways to notify the affected users would be acceptable:

• Sending fax or email,
• Sending registered mail,
• Visiting the users directly,
• Calling the users in case if it is reasonably necessary due to the urgency of the matter. However, the Field Safety Notice still should be delivered to provide the affected users with the full information related to the FSCA.

The authority also allows medical device manufacturers to use any other notification methods they will deem suitable.

The initial notification should be performed within five business days.

In accordance with the applicable regulation, the fact that the affected user has been duly notified should be confirmed by signing the acknowledgment letter or the FSN itself is the acknowledgment letter was not provided. In case if the responsible entity fails to contact the affected user (receives no response), it shall continue such attempts at least three times, and use at least two different ways to contact. If, despite all efforts, the affected user provides no response, the authority should be notified accordingly.

Another important aspect highlighted in the present SFDA guidance relates to record-keeping. In particular, the authority states that the medical device manufacturer, its authorized representative, or importer shall properly document all their actions related to field safety corrective actions and attempts to notify the affected users. According to the SFDA, such records shall contain the following information:

• The date of communication,
• The name of the person,
• The indication of particular means of communication used,
• Contact information of the recipient in case of success,
• The copy of the acknowledgment (or FSN) letter signed by the affected user.

It is also allowed to include additional documents and information if it is reasonably necessary and relevant.

Corrective Action Plan

The medical device manufacturer, its authorized representative, or importer shall provide a plan of field safety corrective actions confirming that all appropriate actions will be taken in accordance with the timeline. Such a plan should be provided within five business days from the day FSCA has been initiated.

In accordance with the SFDA guidance, the corrective action plan should contain the following elements:

• The indication of the particular date the procedures are expected to be completed,
• The list of affected customers,
• The indication of affected categories,
• Detailed information about the number of medical devices subject to the field safety corrective actions, that are already available on Saudi Arabia`s medical devices market,
• The information about the particular actions to be committed by the medical device manufacturer, its authorized representative or importer besides the notification itself (for example, making amendments to the instructions for use, etc.),
• Filled FSCA risk assessment form.

FSCA Implementation

When implementing the field safety corrective actions, the medical device manufacturer, its authorized representative, or importer shall act strictly in accordance with the Corrective Action plan. Any and all actions performed should be properly documented, and the records should be kept to be provided to the authority upon request.

The present SFDA guidance also provides the following rules the parties involved shall follow:

• If the responsible entity fails to complete the actions as prescribed by the Corrective Action plan, it should provide a detailed explanation of such delay,
• In case if it was agreed that the periodic reports will be provided, any delay in providing such reports should be also explained to the SFDA,
• Each of the periodic reports shall contain an indication of the implementation percentage, and also the same for remaining procedures.

Summarizing the information provided here above, the SFDA guidance describes the way the medical device manufacturers, their authorized representatives or importers shall plan and implement field safety corrective actions intended to mitigate risks associated with medical devices placed on the Saudi Arabia`s market.

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Sources:
https://www.sfda.gov.sa/ar/medicaldevices/regulations/DocLib/FSNsEn.pdf