Biologics

Court Rejects FDA HCT/P Designation

David McFarland

— 1 min read
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A Georgia federal court has determined that FDA misread its own regulations in determining that a MiMedx wound care powder product was not a human cell, tissue, or cellular- or tissue-based product (HCT/P) because it was not minimally manipulated. Attorneys Vanessa Hampton and Alan Minsk (Arnall Golden Gregory) write in an online post that the court held that FDA’s reading of its regulation required no deference because the plain language was unambiguous.

While the FDA analysis focused on what the tissue in question did in the donor, the post says, the court held that the plain text points to what the tissue does for the patient. It noted that it was the second federal district court to reach a similar conclusion.

The court sent the decision back to the agency, the attorneys write, because FDA misread its regulation and also treated the MiMedx product differently from comparable products without explanation.

The post says the decision has these impacts on tissue product manufacturers:

  • the court scrutinized the plain text of the regulation and did not automatically defer to FDA;
  • FDA must be consistent or explain why it isn’t;
  • build the comparator record early;
  • frame minimal manipulation around the patient; and
  • keep expectations measured.

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