MiMedx Group, a medical technology company based in Marietta, Georgia, has recently received a warning letter from the U.S. Food and Drug Administration (FDA) regarding the classification of its product, Axiofill.
The FDA determined earlier this year that MiMedx’s pacental-derived tissue products did not meet the requirements for a Section 361 product, which do not require pre-market review. This classification sparked disagreement between MiMedx and the FDA.
Despite the company’s attempts to engage with the agency, a warning letter was sent by the FDA on December 21, reiterating their position. MiMedx continues to maintain that Axiofill has been incorrectly characterized, stating that it is “directly comparable” to another product regulated under Section 361.
It is important to note that the warning letter solely pertains to Axiofill and does not make any safety claims about any of MiMedx’s other products.
Although Axiofill is expected to generate less than 5% of total sales in 2023, MiMedx stands by its previous guidance of full-year sales in the high-teens.
