GRAFTYS SA has received a Request for Designation (RFD) response from the FDA indicating that its patented technology for the combination of calcium phosphate cement with alendronic acid is classified as a medical device for applications in orthopedic and trauma surgery for osteoporotic patients. The Center for Devices and Radiological Health (CDRH) will be the lead agency for premarket review and regulation.
For more information, please contact:
NaviMed International LLC
US representation for (UDIU\V 4″
Chicago, IL, USA