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Office of Device Evaluation will accept amendment to Wright Medical’s bone graft application

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The Office of Device Evaluation of the FDA announced it will accept further amendment to the premarket approval application for Wright Medical’s Augment Bone Graft in lieu of proceeding with the Dispute Resolution Panel scheduled for the week of May 19, 2014.

According to a press release, the premarket approval (PMA) amendment will consist of analyses of pre-existing radiographs of clinical study patients at preoperative and postoperative time points. The Office of Device Evaluation (ODE) has committed to an expeditious review of the PMA amendment and agreed to issue a determination on whether the PMA is approvable no later than 180 days after submission of the PMA amendment. If the PMA amendment fails to result in a reversal of ODE’s previous not approvability determination, Wright Medical intends to renew the Dispute Resolution Panel (DRP) process.

“Since inception of the DRP process, Wright and ODE were encouraged by the FDA Ombudsman to continue discussing alternative ways to resolve the dispute. These discussions proceeded slowly but gathered steam in recent days as the timeline for DRP submissions grew nearer. The result is something we consider to be a good mechanism for moving forward,” Robert Palmisano, president and chief executive officer of Wright Medical, stated in the release. “While this development is cause for somewhat greater optimism than we have thus far had reason to embrace, it is important to reiterate that the parties’ positions are still far apart and there is no guarantee this PMA amendment will result in an approval for Augment Bone Graft. Nevertheless, we are pleased we were able to work collaboratively with FDA to identify a path forward that does not require new clinical studies to get to the next approvability determination.”