On October 23, 2014, the FDA’s Center for Biologics Evaluation and Research issued draft guidance for tissue establishments and healthcare professionals who implant stem cells and other cellular or tissue-based products into human patients. The FDA regulates human cells, tissues or cellular or tissue-based products intended for implantation, transplantation, infusion or transfer into a human recipient (“HCT/Ps”) to prevent the introduction, transmission, and spread of communicable diseases under the authority of section 361 of the Public Health Service Act.
The guidance, which is presented in a Question & Answer format, presents the FDA’s current thinking on the scope of the “same surgical procedure” exception set forth in 21 C.F.R. § 1271.15(b). The “same surgical procedure” exception provides that “[y]ou are not required to comply with the requirements of this part if you are an establishment that removes HCT/P’s from an individual and implants such HCT/P’s into the same individual during the same surgical procedure.” 21 C.F.R. § 1271.15(b). One of the key questions raised by healthcare professionals has been whether multiple surgeries on different dates involving the same patient could be considered the “same surgical procedure.”
According to the draft guidance, procedures consisting of more than a single operation are generally not considered the same surgical procedure. However, as explained in the draft guidance, “under limited circumstances, surgical removal and subsequent implantation of the autologous HCT/P may be considered same surgical procedure even though the removal and future implantation may be a number of days apart. During this time, the HCT/P may be rinsed or cleansed and temporarily stored after being labeled pending implantation, and still be considered same surgical procedure, provided no other processing steps, and no other manufacturing steps beyond being labeled and stored are performed.” The only procedures consisting of more than a single operation specifically mentioned as potentially qualifying for the exception are a “craniotomy with subsequent implantation of the bone flap to reverse the cranial defect” and “parathyroidectomy with subsequent implantation of a portion of the tissue to preserve parathyroid function.” The FDA also reiterated that that the exception applies only to those establishments that both remove and implant the autologous HCT/P at the same establishment. The tissue cannot be stored off-site.