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FzioMed, FDA to postpone Medical Dispute Device Resolution Panel
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FzioMed announced recently that the June 10 Dispute Device Resolution Panel meeting with the FDA regarding its Oxiplex gel product has been postponed, according to a press release.
“We appreciate the continuing cooperation of Office of Device Evaluation staff, the Center Ombudsman’s Office, the Center Director’s Office, and the Commissioner’s Team throughout this process. We look forward to working collaboratively with FDA to analyze and evaluate the additional data,” John Krelle, president and CEO of FzioMed, said in a press release.
The decision to postpone the meeting was agreed upon by FzioMed and the FDA’s Center for Devices and Radiological Health to allow the Office of Device Evaluation time to review additional clinical information for the product, which is an anti-adhesion gel applied during lumbar spine surgery. Final approval of the postponement is expected soon from the FDA appeal authority, the release said.
The panel will decide whether to overturn the Center for Devices and Radiological Health’s denial of the Oxiplex premarket approval application or uphold the previous decision.
Oxiplex has been approved for sale in the European Union since 2002, according to a previous FzioMed press release. In all, it is approved in 70 countries and has been used in more than 350,000 surgeries worldwide.