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FDA guidance means risk regrade for two devices

This article was originally published in Clinica

Executive Summary

Two products are now poised for reclassification by the FDA, with the publication of a final guidance on future product submissions of these devices. The products - implantable intra-aneurysm pressure management systems and hepatitis A blood tests - had previously been classified as class III (high-risk) devices, requiring manufacturers to submit costly premarket approval applications for all new products in this category. Reclassification to class II means the products can be cleared via 510(k), with fewer clinical requirements, a substantially lower user fee and review likely in 90 days or less.

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