PHOENIX, August 28, 2025 — Five amniotic membrane allograft products have received official recognition from the FDA’s Tissue Reference Group (TRG) as human cell, tissue, or cellular or tissue–based products (HCT/Ps). This designation marks a pivotal advancement in regulatory classification, enhancing provider reimbursement and validating these advanced wound care membranes.
Science Significance
These newly designated allografts include multi-layer and fenestrated versions—while one features a triple-layer amnion-chorion-amnion structure, others range from single- to dual-layer amnion configurations. Designed to aid in covering and protecting a variety of wounds—such as surgical incisions, burns, diabetic foot ulcers, and venous leg ulcers—each membrane delivers tailored properties for optimal wound coverage, moisture management, and protection. Recognition as HCT/Ps highlights their biologically rational, minimally manipulated design suited for clinical application.
Regulatory Significance
The TRG’s classification confirms that these products meet the FDA’s criteria for HCT/Ps—recognizing their safety, minimal manipulation, and intended homologous use under 21 CFR Part 1271. This designation helps clarify their regulatory pathway, aligning them with federal tissue regulation standards and ensuring compliance with current good tissue practices.
Business Significance
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This regulatory recognition streamlines the reimbursement process, making it easier for healthcare providers to claim coverage. As a result, these allografts gain broader accessibility, unlocking commercial potential in advanced wound care markets by reinforcing trust in their clinical and regulatory validity
Patients’ Significance
Patients with chronic or complex wounds now benefit from a clearer pathway to access biologically optimized allograft treatments. The ease of reimbursement facilitates wider availability—supporting healing, reducing treatment delays, and improving overall patient outcomes.
Policy Significance
The TRG designation aligns with healthcare policy objectives aimed at enabling innovative, cost-effective therapies. By reinforcing clear regulatory classification, it supports transparent coverage decisions, patient access, and continuity of care—all central to evolving healthcare frameworks targeting value-based treatment models.
Transaction Highlights
Recognition by the FDA’s TRG officially classifies five distinct amniotic membrane allograft products as HCT/Ps, confirming their minimal manipulation and homologous use. This milestone significantly streamlines reimbursement pathways and validates the clinical utility of these advanced wound-care solutions. As this designation propagates among providers, broader patient access is expected—driving both improved healing outcomes and expanded market integration.
Source: BioLab Holdings Press Release
