PRP preparation involves a blood draw and point-of-care processing performed by the treating clinician. That procedure is outside PB's scope: PB supplies donor-derived perinatal products and does not provide guidance on PRP preparation or administration.
Regulatory classification for a given PRP system depends on the specific product, its processing and its intended use. Clinics should consult their own regulatory counsel rather than assuming a single classification applies across all PRP kits.
When comparing PRP to donor-derived allograft options, consider the operational differences. PRP requires in-office centrifugation equipment and a blood draw at each visit, while allografts arrive pre-processed and ready to use. Each category calls for its own recordkeeping, consistent with FTC guidance on substantiating health-related product claims.
PRP preparation and classification differ from donor-derived allografts, so clinics offering both should keep sourcing, consent and recordkeeping distinct rather than treating them as one category.