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Regulatory Roundup: FDA Panels; Proteomics; Experiential Learning; 510(k)s

This article was originally published in The Gray Sheet

Executive Summary

FDA has officially scheduled the first meeting of its Medical Devices Dispute Resolution Panel in more than seven years to assess the case of FzioMed Inc.’s PMA for the Oxiplex gel for lumbar spine surgery. An ophthalmic devices panel has been set for a new corneal implant, and more regulatory news.

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