Adipose-derived tissue is autologous and harvested from the patient by the treating physician. Harvesting and processing procedures are outside PB's scope. This is a different sourcing model than donor-derived tissue recovered from a consenting third-party donor at delivery.
Regulatory treatment of a given adipose-derived system depends on its specific processing method. Clinics and their counsel should request the processing description for any system under consideration rather than assuming a single classification applies across mechanical and enzymatic methods.
Because adipose-derived tissue and donor-derived allografts rely on different sourcing, processing and regulatory pathways, clinics stocking both should keep separate consent forms, device or kit documentation, and recordkeeping for each category rather than presenting them as interchangeable in internal materials or patient-facing paperwork.
Regulatory treatment of adipose-derived systems varies by processing method, so clinics should confirm the specific method, mechanical or enzymatic, and consult counsel before adopting a system.