Vitti Labs Prevails in Lawsuit Against FDA Over "Minimal Manipulation" Criteria for Section 361 HCT/Ps

US District Court decision stands to benefit manufacturers of low-risk human tissue products

LIBERTY, Mo., March 27, 2026 /PRNewswire/ -- Vitti Labs (or "the Company") announced today that U.S. District Court Judge Brian C. Wimes granted the Company's motion for summary judgment in its lawsuit against the Food and Drug Administration (FDA) over the correct standard for determining whether human tissue products qualify for regulation under a low-risk framework. Vitti Labs works tirelessly to make available the highest quality human cell, tissue, or cellular or tissue-based products (HCT/Ps) regulated under Section 361 of the Public Health Service (PHS) Act. For the past year, Vitti Labs has been fighting a determination by FDA that would have severely limited the Company's ability to offer new umbilical cord-based Section 361 HCTP/s, by focusing only on the original relevant characteristics of the tissue in the tissue donor when determining whether such a tissue has been more than "minimally manipulated." On March 18, 2026, Judge Wimes (of the U.S. District Court for the Western District of Missouri) granted Vitti Labs' motion for summary judgment in its lawsuit challenging FDA's position.

Judge Wimes ruled as follows:

• FDA's interpretation of its regulation to focus only on the tissue's characteristics in the donor is "plainly erroneous." "The entire regulatory scheme for HCT/P's revolves around sending safe products to patients, so it would not be logical to cut out consideration of recipients in the minimal manipulation analysis."
• "The FDA's interpretation that the only original relevant characteristic of an umbilical cord is its function as a conduit for blood flow between a mother and fetus was incorrect and an "erroneous interpretation".
• "The FDA is instructed to reconsider its conclusion consistent with the understanding that original relevant characteristics of structural tissue include the functions of the tissue in the donor that might aid a recipient." (underlining added).

Philipp R. Vitti, Vitti Labs' Chief Science Officer, stated: "Judge Wimes' decision is an important victory for Vitti Labs and the entire Section 361 HCT/P industry, and allowing patients to continue to be allowed access to wound grafts and other tissue-based products. We will continue to advocate and defend the proper interpretation of the Section 361 HCT/P "minimal manipulation" criteria as the US Department of Health and Human Services intended it. This regulatory classification must be preserved in its entirety as it is critical for human tissue banking and organ donation to exist in the United States."

About Vitti Labs:
Vitti Labs™ is an AATB accredited, cGMP certified, and FDA registered tissue bank which focuses on life science research, development, and manufacturing.

SOURCE Vitti Labs