FzioMed Announces Date for Medical Device Dispute Resolution Panel on Oxiplex® (press release)
FzioMed, Inc., a medical device manufacturer specializing in biomaterials, has received notification from FDA that the Medical Device Dispute Resolution Panel (MDDRP) will convene and make a decision on the approvability of Oxiplex Gel on June 10, 2014.
Oxiplex is an absorbable, clear, viscoelastic hydrogel that is applied during lumbar spine surgery. Oxiplex has been approved for sale in the European Union since 2002 and is now approved in 70 countries. It has been used in more than 350,000 surgeries worldwide. The Company has been working for 12 years to gain FDA approval to market this device in the U.S.
The MDDRP provides advice to the Commissioner of the U.S. Food and Drug Administration (FDA) on complex or contested scientific issues between the FDA and medical device sponsors, applicants, or manufacturers relating to specific products, marketing applications, significant regulatory decisions and actions by the FDA, and Agency guidance and policies. The Panel is convened infrequently and makes recommendations on issues that are lacking resolution, in this case they will decide whet...
