ASPS Comments on FDA Same Surgical Procedure Guidance
ASPS has submitted comments to the Food and Drug Administration (FDA) regarding the draft guidance document titled "Same Surgical Procedure Exception Questions and Answers Regarding the Scope of the Exception" released in October 2014.
The draft guidance outlines certain circumstances under which an establishment may qualify for an exception from the requirements under Part 1271 (concerning the regulation of Human Cells, Tissues, and Cellular and Tissue-Based Products or HCT/P's), including the exception in § 1271.15(b). Section 1271.15(b) states: "You are not required to comply with the requirements of this part if you are an establishment that removes HCT/P's from an individual and implants such HCT/P's into the same individual during the same surgical procedure."
As outlined in the draft guidance, the FDA's view is that autologous cells or tissues that are removed from an individual and implanted into the same individual without intervening processing steps beyond rinsing, cleansing, or sizing, or certain manufacturing steps (namely, labeling and storing), raise no additional risks of contamination and communicable disease transmission beyond that which is typically associated with surgery. FDA considers the same surgical procedure exception to be a narrow exception to regulation under Part 1271.
ASPS expressed concerns that the narrow exception may unintentionally result in many plastic surgeons (or the facilities in which they practice) being subject to FDA's requirements for tissue banks. In particular, ASPS expressed concerns that the process of centrifugation of liposuction aspirates in preparation for autologous fat grafting, morselized cartilage for grafting, and dilation of a vessel graft using a solution containing a pharmacologic agent would not fall under the narrow exception. Thus, ASPS requested that FDA clarify in the final guidance that these practices are part of the overall exception.
In addition, given that ASPS anticipates that there will be other common standard-of-care-surgical techniques impacted that are not readily apparent, ASPS would prefer that FDA use a broader definition for the exception in § 1271.15(b) and that such definition be more in line with the broader range of potential activities outlined above.
Finally, ASPS asked to have a dialogue with the FDA about other common surgical practices that could also be affected by the proposed guidance document. ASPS will continue to follow the draft guidance accordingly.