21 CFR 1271.10 sets minimal manipulation as one of the criteria for the section 361 pathway. For structural tissue, the standard asks whether processing changes the tissue's relevant characteristics for its intended structural function. For cells and nonstructural tissue, a separate standard asks whether processing alters the relevant biological characteristics of the cells or tissue.
Processing steps such as recovery, cleaning, sterility testing, cryopreservation or lyophilization are examples of the kinds of steps a supplier may describe when documenting how a tissue product was prepared. Whether a given combination of steps keeps a specific product within the minimal manipulation standard for its intended use is a determination made against the regulation, not a label a supplier can simply assert.
Buyers building a vendor qualification file should request the supplier's processing description and certificate of analysis for a given lot. These are the documents a clinic or its counsel would review to evaluate minimal manipulation for a specific intended use, rather than relying on a general claim of compliance.
These products are not FDA approved or licensed for any disease or condition. Information is for licensed healthcare professionals and is not medical or legal advice.
Understanding how the minimal manipulation standard applies to a given processing method helps a clinic evaluate supplier documentation rather than relying on a general compliance claim.