10.13.14
RTI Surgical Inc. has received a letter from the U.S. Food and Drug Administration (FDA) regarding the company’s map3 cellular allogeneic bone graft.
According to the company, the letter addresses “some technical aspects” of the processing of the map3 allograft, as well as language included in the map3 website.
The spine company has submitted an initial response to the FDA letter, and is preparing a comprehensive package of data to address the agency’s comments and provide clarifying information regarding the technical components of the implant processing, according to company officials, who noted that they “understand” the basis for questions and points raised by FDA in the letter and “feel confident that in developing map3 and processing of map3, we 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.”
RTI Surgical makes biologic, metal and synthetic implants. The company is headquartered in Alachua, Fla., and has four manufacturing facilities throughout the United States and Europe. RTI’s implants are used in sports medicine, general surgery, spine, orthopedic, trauma and cardiothoracic procedures.
According to the company, the letter addresses “some technical aspects” of the processing of the map3 allograft, as well as language included in the map3 website.
The spine company has submitted an initial response to the FDA letter, and is preparing a comprehensive package of data to address the agency’s comments and provide clarifying information regarding the technical components of the implant processing, according to company officials, who noted that they “understand” the basis for questions and points raised by FDA in the letter and “feel confident that in developing map3 and processing of map3, we 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.”
RTI Surgical makes biologic, metal and synthetic implants. The company is headquartered in Alachua, Fla., and has four manufacturing facilities throughout the United States and Europe. RTI’s implants are used in sports medicine, general surgery, spine, orthopedic, trauma and cardiothoracic procedures.