Essentials of European Medical Device Regulatory Affairs

FSCA

• WHAT IS FSCA?

• Field Safety Corrective Action

An action taken by a manufacturer to reduce the risk of death or serious deterioration in the state of health of a user, patient or other person associated with devices which are already in the market.

This may include:-

• Providing users with new IFU’ s • Requesting users to return product • Requesting users to destroy product • Requesting users to modify product • And much more…

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FSCA

• FSCA must be reported to the CA in each of the countries where it is being conducted – Before the action is implemented • Provide opportunity to comment (suggest 48hrs) but not at the expense of patient safety !!

• Advisable to co-ordinate your action across all affected countries

• Consider notifying EU member states that are not affected

• Remember to prepare an FSCA strategy – consider timelines, notifications, method of message delivery, reconcilliation method and targets, how to provide replacements, how to handle enquiries, media / press, etc., etc ?

• Remember to notify your NB (if applicable)

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