FDA Just Reaffirmed That You Can’t Use Umbilical Cord Blood in Orthopedics Without A Drug License Or Specific Permission Thru a RMAT Or Other FDA Program

https://lnkd.in/eR7Jpq2

FDA clearly states that umbilical cord blood is NOT exempt from registering as a biologics drug under section 351.

FDA states that “….using the umbilical cord blood products to treat orthopedic conditions is not homologous use as defined in 21 CFR 1271.3(c).”

If you are using or selling umbilical cord blood for use in orthopedics, regardless of stem cell claims or not….you better register thru section 351 or get a RMAT!!!