Companies breathe a temporary sigh of relief as the FDA reissues its guidance documents that could reduce allograft availability.
Manufacturers of allograft tissue and the medical device companies that market these products felt more at ease as the FDA reissued guidance set to take effect on May 4, with a new deadline for public comment on July 7. According to the American Association of Tissue Banks (AATB), the recommendations in their current form could reduce the availability of allograft tissues by 40%. The FDA’s recommendations aim to mitigate the risk of sepsis and Mycobacterium tuberculosis (Mtb) transmission when screening potential donors.
The tissue and blood banking industries have urged the agency to withdraw its current guidance and engage in a dialogue to review the actions already taken to mitigate the risk of disease transmission related to sepsis and Mtb. In this article, SmartTRAK examines new FDA recommendations, the concerns raised by these associations and their potential impact on the more than 2.5MM tissue transplants and over 15MM blood transfusions performed annually.
The topics covered in this downloadable SmartTRAK Perspective article are:
- Background to the Release of the Guidance Document
- Origin of the Issue
- Guidelines Published by the FDA
- Coordinated Response and Concerns from Trade Organizations
- Companies and Products Potentially Impacted
- Next Steps
Click the button below to download and read the complete "FDA Guidance Documents Could Seriously Impact Access to Allograft Tissue" article by David Shepard, SmartTRAK Lead Analyst, Orthobio & Regen.
