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.”
FDA Draft Guidance for HCT/Ps
In this article:
- FDA Regulations on Minimal Manipulation of Human Cells, Tissues, and Cellular and Tissue-Based Products
- FDA Guidance Documents
- FDA Draft for Manipulating HCT/Ps
- Additional FDA Guidelines for Medicine with HCT/Ps
Since that time, we have not heard from the FDA about how they have integrated the public feedback.
FDA Guidance for the Industry on HCT/Ps
FDA Regulations on 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.
FDA Guidance Documents
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.”
FDA Draft for Manipulating HCT/Ps
We have linked this draft guidance document below to help you in your quest for understanding the FDA’s regulatory process for HCT/P’s. While you cannot expect it to give you crystal clear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.
Minimal Manipulation of Human Cells, Tissues, and Cellular and Tissue-Based Products
Additional FDA Guidelines for Medicine with HCT/Ps
Are there other regulatory documents we should link to on this page? Comment below and we’ll update it with your recommendations.
So far, how do you view the FDA’s current regulations on FDA guidance on clinical trials for HCT/Ps? Share your opinions in the comments section below.
About BioInformant
BioInformant is the first and only market research firm to specialize in the stem cell industry. BioInformant research has been cited by major news outlets that include the Wall Street Journal, Nature Biotechnology, Xconomy, and Vogue Magazine. Serving Fortune 500 leaders that include GE Healthcare, Pfizer, and Goldman Sachs. BioInformant is your global leader in stem cell industry data.