Rationale

F3206 passed ballot for its 5-year renewal in July 2025 and the new version is published. However, we received an email comment with regard to F3206 as follows: “Selection of a cell line is not compatible with FDA requirements where the therapeutic product is expected to be used for biocompatibility testing. The standard should be revised to include considerations for use of therapeutic cells including stem cells.” In response to this comment, we added one sentence to section 5.1: “If the device is to be used for delivery of a specific cellular therapeutic product, then the therapeutic cells could be used for testing.” For this current ballot, only the addition of this single sentence to Section 5.1 is under ballot. The rest of the document is not up for ballot. An Affirmative vote indicates that you support addition of the sentence. A Negative vote indicates that you do not support addition of the sentence. A Negative vote has no bearing on the rest of the document and will not affect the current active status of F3206.