FDA Stem Cell & HCT/P Regulations: What to Watch Into 2027

Stem cell regulations are under the spotlight. Can we expect changes into 2027?

Stem cells are currently regulated under Section 361 if they meet all the standards for 361 stem cell and other human cells, tissues, and cellular and tissue-based products (HCT/Ps), including minimal manipulation and homologous use requirements. 

For most regenerative medicine clinics, this is an important legal and regulatory differentiator. 

Products classified under Section 351 are subject to a different regulatory framework, including applicable biologics licensing and manufacturing requirements, which can introduce significant complexity.

We’re following several discussions, legal cases, and FDA/HHS dockets related to HCT/Ps. 

If you need tailored guidance on how these regulatory developments could affect your businesses, book a call with Restore Health Consulting to discuss your regulatory questions and compliance needs. 

Two court cases with potential implications for HCT/P manufacturers

In MiMedx v. FDA (N.D. Ga., September 21, 2026) and Vitti Labs v. FDA (W.D. Mo., March 18, 2026), two district courts reached similar conclusions: “relevant characteristics” must be assessed in terms of the tissue’s utility in the recipient, not only its function in the donor. Both court cases also challenged how “minimal manipulation” standards are applied under Section 361. 

In MiMedx v. FDA, the Northern District of Georgia vacated the FDA’s determination that MiMedx’s placental-derived AXIOFILL is not a Section 361 HCT/P but a 351 biological product. AXIOFILL is an acellular human placental extracellular matrix (ECM) derived from the placental disc. It does, therefore, not contain stem cells or any other cells. 

The court held that the FDA incorrectly interpreted its “minimal manipulation” regulation by focusing on the placental disc’s function in the donor instead of considering the original characteristics of the tissue relevant to its utility in the recipient. 

The court also found the FDA's classification of AXIOFILL inconsistent with its classification of similar human-derived particulate products and therefore “arbitrary and capricious” under the APA.

In Vitti Labs v. FDA, a federal court likewise vacated FDA’s determination that CORDGRAFT, an umbilical cord-derived HCT/P, should be regulated as a Section 351 biological product. CORDGRAFT contains non-viable cellular tissue matrices and, therefore, also does not contain live, functional stem cells.

The court found FDA’s interpretation of the “minimal manipulation” criterion unlawful under the APA, rejecting its narrow focus on the tissue’s original relevant characteristics in the donor rather than its potential use in the recipient.

The interpretation of “minimal manipulation” is a common limiting factor for companies wanting to bring similar human tissue products to market without seeking approval as a drug or biologic under the 351 pathway.

The implications remain uncertain. Appeal windows are still open, and FDA may revisit the homologous use question on remand. The cases could influence future classification decisions, but they do not automatically establish a new pathway for other HCT/P products.

A citizen petition proposes a separate 361 pathway for stem cells

Filed in December 2025, the petition proposes amending 21 CFR § 1271.10(a) to allow for stem cell products to be regulated solely as 361 HCT/Ps, provided that their production facilities comply with cGMP and certain production facility requirements.

The petitioners argue that this approach could expand patient choice and responsible access to regenerative therapies while maintaining essential safety safeguards.

The proposal would represent a policy change, not a change to current requirements. Its potential impact will depend on whether FDA takes action and what conditions any resulting policy establishes.

FDA has an open Part 1271 comment window

Docket FDA-2026-N-9638 concerns an information collection notice for establishments regulated under Part 1271, with comments due November 9, 2026.

FDA is accepting public comments on how information is collected and documented for HCT/Ps. It covers requirements under 21 CFR Part 1271, including establishment registration and product listing, recordkeeping, and certain information disclosures.

The public comment period is open to regenerative medicine companies, patients, and other interested stakeholders.

For HCT/P establishments and regenerative medicine companies, this is an opportunity to highlight administrative burdens, identify bottlenecks, and recommend more efficient information-management processes.

But the public comment process also allows other perspectives to be heard.

Patients, caregivers, and advocates can share their experiences and perspectives on how the regulatory framework affects them and what could be improved. 

In his submission, Dustin Bunch, a former firefighter and spinal cord injury survivor, shared his personal experience with regenerative medicine and called on the FDA to consider how information systems could better capture patient outcomes, long-term follow-up, safety information, functional changes, and medication use.

Bunch urged the FDA to ensure that patient perspectives and meaningful real-world outcomes remain part of the information considered as it develops and administers its HCT/P regulatory framework.

His comment also highlights a broader question: how can regulatory systems protect patients while ensuring that the information collected is useful for evaluating safety, understanding outcomes, and informing future research and innovation?

These are important considerations, although the current docket is specifically focused on the burden and utility of existing information-collection requirements. It does not propose changes to the underlying HCT/P regulatory framework or the criteria distinguishing products regulated under Section 361 from those regulated under Section 351.

HHS is examining the classification of donor-derived islet cells

What would change if deceased donor islet cells were regulated as organs rather than biological products?

On September 23, 2026, the U.S. Department of Health and Human Services (HHS) issued a Request for Information (RFI) seeking public input on how deceased donor islet cells and related cell products should be regulated (Docket FDA-2026-N-10738).

Islet therapies offer a viable option for eligible patients with T1D who meet strict criteria. The key question is whether unmodified deceased donor islet cells should be classified as organs for transplantation rather than biological products.

Currently, the FDA regulates deceased donor islet cells as biological products under Section 351 of the Public Health Service Act, a framework that requires a Biologics License Application (BLA).

Advocates argue that these requirements create significant barriers to making the treatment more widely available. They support considering an organ-transplant framework that would integrate eligible donor islet cells into the national transplantation system.

If unmodified deceased donor islet cells were classified as organs, oversight of their procurement, allocation, and transplantation could shift from the FDA's product-based framework to the framework involving the Health Resources and Services Administration (HRSA) and the Organ Procurement and Transplantation Network (OPTN).

The RFI is seeking information to inform HHS's consideration of the regulatory approach. No final reclassification has been announced.

And importantly, the RFI does not apply to stem cell-derived islet products, which remain subject to their existing regulatory framework.

In addition, this is a separate Section 351 question, not a proposed change to the Section 361 framework for stem cells. However, it highlights broader questions about how donor-derived cellular products are classified and regulated.

For example, the RFI also asks whether classifying unmodified deceased donor islet cells as organs could set a precedent for other donor-derived cellular products.

The outcome could inform broader regulatory discussions about how these products are classified and overseen, although it would not automatically change the regulatory status of other cell therapies.

Comments are due November 9, 2026.

Industry advocates are pushing for a policy shift

At PepMed 2026, stem cell industry participants argued that FDA’s approach to compounded peptides could provide a precedent for a different regulatory approach to stem cells.

Some industry observers have predicted FDA roundtables before the end of the year, although the agency declined to confirm whether any are planned. STAT News reported on these efforts.

What this means for stem cell therapies going forward

Several developments could influence the regulatory landscape into 2027, but they are at different stages. Court rulings may affect specific classification disputes, the citizen petition seeks a broader policy change, and industry advocacy may encourage further FDA discussion.

None of these developments, on its own, changes the existing criteria for regulation solely under Section 361.

For manufacturers and regenerative medicine clinics, the practical priority remains understanding how current requirements apply to their products, manufacturing processes, and intended uses while monitoring developments that could affect future regulatory decisions.

A potential shift in policy is worth watching, but businesses should not assume a new regulatory pathway will become available until the applicable requirements actually change.

Need more guidance?

Restore Health Consulting helps businesses in regenerative medicine and other regulated healthcare sectors understand complex regulatory requirements and plan their next steps. 

Our team of consultants also advises and supports CGT labs and other clinical-type lab build outs that need design and planning assistance, including 351 facilities. 

Book a call with us to discuss your organization's specific needs.

Sources:

FDA Regulation of Human Cells, Tissues, and Cellular and Tissue-Based Products (HCT/Ps): https://share.google/rTxR4j4cf4PW6lNlI 

MiMedx v. FDA: https://investors.mimedx.com/news-releases/news-release-details/mimedx-announces-favorable-federal-court-ruling-axiofillr 

Vitti Labs v. FDA: https://www.khlaw.com/news/keller-and-heckman-secures-important-district-court-victory-vitti-labs-fda-tissue-product 

Citizen petition: https://share.google/e01AhzGLuQTnVQG9F 

FDA-2026-N-9638-0001: https://www.regulations.gov/document/FDA-2026-N-9638-0001 

FDA-2026-N-9638-0001, Comment from Dustin Bunch: https://www.regulations.gov/comment/FDA-2026-N-9638-0002 

FDA classification of donor-derived islet cells: https://www.federalregister.gov/documents/2026/09/24/2026-19563/improving-patient-access-to-deceased-donor-islet-cells-and-cell-products-request-for-information 

PepMed 2026 STAT: https://www.statnews.com/2026/10/05/stem-cell-industry-seeks-fda-regulation-like-peptides/

Disclaimer: This article is intended to provide general information. It should not be construed as legal, regulatory, or medical advice. Readers are encouraged to consult an attorney for guidance specific to their circumstances.