Answer: If FDA determines that the intended use of an FCS is no longer safe, it will contact the notifier in writing, stating the basis for its determination. The notifier will be given an opportunity to show why the FCN should continue to be effective. The deadline for the notifier?s response will be specified in FDA's letter to the notifier.
If FDA holds to its determination that the FCS is no longer safe, it will publish a notice to that effect in the Federal Register. FDA's determination that an FCN is no longer effective will be considered final agency action subject to judicial review.
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