In September 2016, the FDA hosted a public hearing to review draft guidances pertaining to the FDA regulation of stem cells. It addressed the regulation of human cell and tissue-based products (HCT/Ps), defined by the FDA in § 1271.3(d) as “articles containing or consisting of human cells or tissues that are intended for implantation, transplantation, infusion, or transfer into a human recipient.”
Since that time, we have not heard from the FDA how they have integrated the public feedback.
Minimal Manipulation of Human Cells, Tissues, and Cellular and Tissue-Based Products
In the meantime, the regenerative medicine community is left with a reference document titled, “Minimal Manipulation of Human Cells, Tissues, and Cellular and Tissue-Based Products.
As stated by the FDA in the document itself, “FDA’s guidance documents, including this guidance, do not establish legally enforceable responsibilities. Instead, guidances describe FDA’s current thinking on a topic and should be viewed only as recommendations, unless specific regulatory or statutory requirements are cited.”
We have linked this draft guidance document below to help you in your quest for understanding the FDA’s regulatory process for HCT/P’s. While you cannot expect it to give you crystal clear boundaries, it will give you general guidelines by which to operate.
Additional Regulatory Documents Affecting HCT/Ps
Are there other regulatory documents we should link to on this page? Comment below and we’ll update it with your recommendations.