RTI Surgical has received a letter from the FDA regarding its map3 cellular allogeneic bone graft. The letter addresses some technical aspects of the processing of the map3 allograft, as well as language included in the map3 website. The company has submitted an initial response to the FDA letter, and is preparing a comprehensive package of data to address the agency’s comments.
In its response, RTI Surgical also provides clarifying information regarding the technical components of the implant processing. They state that they believe that they understand the basis for questions and points raised by FDA in the letter and claim that they feel confident that in developing map3 and processing of map3, they have properly considered the relevant regulatory questions. Additionally, the company has removed the website pending thorough review and revisions as needed.
“We will work diligently to fully address any concerns or questions the FDA has,” said Brian K. Hutchison, president and CEO of RTI. “We have carefully considered the regulatory pathway of this important implant from the beginning of development, and we continue to be confident in the science behind our map3 allograft.”