Regulatory Roundup: FDA Panels; Proteomics; Experiential Learning; 510(k)s
This article was originally published in The Gray Sheet
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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CDRH is asking for another round of volunteers to allow officials to visit manufacturing and clinical facilities to get first-hand perspective of how they operate as part of the center's Experimental Learning Program.
FDA granted FzioMed’s petition for an independent review of its Oxiplex gel PMA by the Medical Devices Dispute Resolution Panel in response to FzioMed’s November 2012 petition. The agency deemed the device, intended for use in spine surgery, as “not approvable” in 2008.
An FDA dispute resolution body all but halted Cardima's chances to turn around the fortunes of its Revelation Tx microcatheter NavAblator ablation system April 19, voting 5-0 not to recommend approval of the product