Field Safety Corrective Action (FSCA) constitutes a crucial measure undertaken by a manufacturer to address either technical or medical factors that necessitate a systematic recall of devices of the same type. This action involves notifying the National Competent Authority regarding the rationale behind the recall. In the realm of in vitro diagnostics (IVDs), FSCA entails a manufacturer-initiated step to mitigate the risk of severe health deterioration or death linked with the usage of an IVD product that is already available in the market. Similarly, for medical devices, FSCA serves as a proactive approach taken by manufacturers to minimize the risk of life-threatening consequences or significant health decline associated with the use of a medical device that is already in circulation. These actions necessitate communication through a field safety notice, facilitating the dissemination of pertinent information to users and the relevant Medical Device Authority. Notably, FSCA is a post-market imperative governed by established regulatory guidelines, aiming to enhance safety and regulatory compliance.
To initiate FSCA, the Medical Device Authority may solicit its execution in specific cases such as customer complaints and mandatory problem reporting. The communication mechanism for FSCA is through a field safety notice, which should be shared with both users and the Medical Device Authority either prior to or during the corrective action implementation, ensuring transparency and coordinated response to potential safety concerns. This process aligns with the regulatory framework, fostering a swift and effective response to safeguard public health.
Signal Management Process
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