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# AdvaMed Critiques FDA Homologous Cell Use Guidance
- URL: https://www.fdaweb.com/advamed-critiques-fda-homologous-cell-use-guidance/
- Published: 2016-05-03T12:00:00.000Z
- Updated: 2026-09-14T20:59:01.000Z
- Author: David McFarland
- Tags: Devices, #legacy-id-D5135555

AdvaMed says there are several items in an FDA draft guidance on homologous use of human cells, tissue, and cellular and tissue-based products (HCT/Ps) that industry views positively, and several areas where industry disagrees or believes that improvements are needed. In a 4/20 comment [letter](https://www.regulations.gov/contentStreamer?documentId=FDA-2015-D-3581-0011&attachmentNumber=1&disposition=attachment&contentType=pdf&ref=fdaweb.com), it says the positive items are: **(1)** abandoning the term “main function” and replacing it with “basic function(s),” which should be clarified; **(2)** acknowledging that basic functions and not just anatomical location determine homologous use; **(3)** allowing HCT/Ps to possess both structural and non-structural attributes and describing the “basic function or functions” of structural and non-structural tissue; **(4)** recognizing that dermis is separate from epidermis in terms of properties and function; **(5)** defining “repair, reconstruction, replacement, or supplementation”; **(6)** acknowledging that claims should be supported by evidence; and **(7)** acknowledging that the science related to homologous use may evolve.

The letter says that aspects of the draft guidance with which AdvaMed’s members disagree or believe should be improved include: **(1)** the narrow definition of homologous use of amnion provided in the draft; **(2)** “manufacturer’s objective intention,” which speaks to intended use beyond what a manufacturer has put in the labeling, is inconsistent with FDA’s currently proposed regulation related to “intended use,” and suggests a policy change that should go through formal notice and comment rulemaking.

AdvaMed calls on FDA to cite more specific examples to provide context to the agency’s decision-making process. It said this could be done as an appendix to the guidance in a tabular format that would be updated periodically.