The term 'orthobiologics' groups together materials with very different origins: autologous preparations made from the patient's own blood, marrow or fat, and allogeneic preparations made from donated umbilical cord, placental or amniotic tissue. Marketing language sometimes treats the category as a single thing, but the underlying biology differs across these subcategories.
Regulatory treatment within the category should not be inferred from whether a preparation is autologous, same-day, minimally manipulated or allogeneic. Allogeneic donor-derived products are evaluated under the HCT/P framework, where whether a given intended use is regulated solely under section 361 depends on minimal manipulation, homologous use and absence of a systemic effect, a case-by-case determination for the clinic and its counsel. Some exosome preparations are instead regulated as biologic drugs under section 351. FDA has stated there are no FDA-approved exosome products, and purchase and clinical-use decisions for those products belong to the physician with their own regulatory counsel.
Buyers sourcing within the broader orthobiologics category should ask any supplier to identify which regulatory pathway applies to the specific product being purchased, and should request pathway-specific documentation rather than assuming a single set of claims or paperwork covers every product carrying the orthobiologics label.
Products marketed under the single 'orthobiologics' umbrella can follow different regulatory pathways, so buyers should confirm the pathway and documentation for each specific product rather than the category as a whole.