“It’s Alive! It’s Alive!”: Court Rejects FDA’s HCT/P Designation as Arbitrary and Capricious

Key Takeaways

• FDA classification decisions face greater judicial scrutiny. A federal court rejected FDA’s HCT/P analysis, giving tissue product manufacturers additional grounds to challenge unsupported classification decisions.
• Regulatory pathway decisions carry significant commercial consequences. The ruling may strengthen manufacturers’ arguments for less burdensome classifications, potentially affecting premarket authorization requirements, development costs, and commercialization timelines.
• Product comparisons are critical to FDA classification strategy. Manufacturers should document comparable products and prior FDA decisions early to support regulatory submissions and potential challenges.

The Edgar Winter Group’s 1972 instrumental track, “Frankenstein,” and Gene Wilder’s “It’s alive!” exclamation in the 1974 Young Frankenstein movie came to mind when we read a recent court decision that rejected a Food and Drug Administration decision classifying a human tissue-based wound care powder as a biological product.¹ For human tissue product manufacturers who have long felt that FDA’s classification decisions have taken on a life of their own, the decision reminds us that judicial scrutiny is alive and well.

MiMedx v. FDA: Background and HCT/P Classification Dispute

• The issue before the court was how FDA determined whether a human cell, tissue, or cellular or tissue-based product (“HCT/P”) is “minimally manipulated,” including the methods and metrics it applies, and whether the agency could classify the product as a biological product when similar products had previously been classified as medical devices.
• The sponsor of a wound-care powder product, made from extracellular matrix isolated from placental tissue, sought classification as a 361 HCT/P, which carries less stringent regulatory requirements.² To qualify for this categorization, a product must meet four criteria outlined in 21 C.F.R. § 1271.10, including that it is “minimally manipulated” and intended for “homologous use.”
• FDA believed the product was not minimally manipulated because processing destroyed the placenta’s original function as a barrier between mother and fetus, and it suggested (in a footnote) that the product also failed the homologous use criterion.
• The court disagreed and sent the decision back to FDA, holding that:
  1. the agency misread its own minimal manipulation regulation by looking at the tissue’s utility for “reconstruction, repair, or replacement” in the donor rather than the recipient, and
  2. FDA treated the product differently from comparable products without explanation.

Why the Court Rejected FDA’s HCT/P Classification

The Plain Text Was Clear

The court held that FDA’s reading of its regulation required no deference because the plain language was unambiguous after a full review of its text, structure, history, and purpose.

FDA Asked the Wrong Question

According to 21 C.F.R. § 1271.3(f), structural tissue is minimally manipulated if processing does not alter “the original relevant characteristics of the tissue relating to the tissue’s utility for reconstruction, repair, or replacement.” FDA focused on what the tissue did in the donor. The court held that the plain text points to what the tissue does for the patient, and it noted a second federal district court had reached a similar conclusion.³

FDA Was Inconsistent

FDA had classified several similar products with the same components and intended use as medical devices and could not justify its disparate treatment in the case. The agency cited generally to “the scientific literature” but never explained what made this product different. Treating structurally-similar products differently without a well-founded explanation, the court reasoned, is arbitrary and capricious.

What the Ruling Means for Tissue Product Manufacturers

• The court scrutinized the plain text of the regulation and did not automatically defer to FDA. FDA’s interpretation of its own rules receives no special weight unless the text is genuinely ambiguous. Here, the court resolved the key questions on the text alone. The ruling follows the Supreme Court of the United States’ narrowing of longstanding judicial deference to agency interpretations, placing a greater burden on FDA to justify its decisions.⁴
• FDA must be consistent or explain why it is not. If FDA reaches a different classification for a product that resembles other structurally-similar products, it must identify the differentiating features with reasonable specificity and support them with evidence in the administrative record.
• Build the comparator record early. If a company submits a Pre-Request for Designation or a Request for Designation, it should identify similar products and FDA’s prior classifications of them, so that any inconsistent treatment is documented in the administrative record.⁵
• Frame minimal manipulation around the patient. This is the second federal district court to hold that FDA must consider characteristics relevant to the patient rather than the donor.⁶ Sponsors of processed structural-tissue products may have a stronger basis to argue for a 361 HCT/P designation.
• Keep expectations measured. This is a single district court decision that does not bind FDA in other matters outside the court’s jurisdiction. Still, it means that courts are willing to push back when FDA’s classification decisions lack a reasoned basis.

The courts are “alive” and willing to push back where FDA misinterprets the plain text of its regulations. AGG will continue to track future and pending rulings in this space.

For guidance on these issues, please contact a member of AGG’s Food & Drug team.

[1] MiMedx Group, Inc. v. FDA, No. 1:24-cv-01287, N.D. Ga. September 21, 2026.

[2] HCT/Ps that meet all of the criteria in 21 C.F.R. § 1271.10 are regulated only under section 361 of the Public Health Service Act and 21 C.F.R. Part 1271. Premarket review does not apply in this context. If an HCT/P does not meet these criteria, it is regulated as a drug, device, or biological product under section 351 of the Public Health Service Act and/or the Federal Food, Drug, and Cosmetic Act, and other applicable regulations. Premarket authorization of the HCT/P will also apply.

[3] See Vitti Labs, LLC v. FDA, No. 4:25-cv-00011-BCW, W.D. Mo. March 18, 2026.

[4] See Loper Bright Enters. v. Raimondo, 603 U.S. 369, 392, 2024. Holding that courts may automatically not defer to an agency’s interpretation of its regulations.

[5] A Pre-Request for Designation is an informal, non-binding written submission to FDA to seek early feedback on a product’s likely regulatory classification. A Request for Designation is a formal submission asking the agency to classify the product, resulting in a binding legal determination.

[6] See Vitti Labs, No. 4:25-cv-00011-BCW.