The FDA hit MiMedx Group with a warning letter, citing the maker of regenerative biomaterials products for the classification of its placental collagen matrix designed to treat wounds found in surgical settings.
In its letter (PDF), the FDA said MiMedx's Axiofill doesn't fall under Section 361 of the U.S. Public Health Service (PHS) Act, which allows lower-risk and minimally processed cell- and tissue-based products to be sold under fewer regulatory requirements.
Instead, the product should fall under Section 351 of the law, which regulates products such as biologics that require pre-market approval, according to the agency.
In essence, the FDA has taken the stance that Axiofill is an unlicensed biological product.
“Based upon this information, we have determined that your actions have violated the [Federal Food, Drug, and Cosmetic Act] and the PHS Act," the regulatory agency said.
The FDA issued the letter after visiting two MiMedx sites in Georgia last February and March.
In making its case, the FDA said Axiofill fails to meet the "minimal manipulation criterion" set forth under the law, and that the company's procedure "alters the original relevant characteristics of the placenta related to its utility for reconstruction, repair, or replacement."
MiMedx, for its part, maintains its product is similar to others on the market and that the FDA "is not consistently applying the rules for permitted use," the company said in a press release late last year.
“We believe that Axiofill has been incorrectly characterized by the agency, particularly in light of the existence of other Section 361 products currently available on the market,” Joseph Capper, MiMedx chief executive, said in the release. “While Axiofill sales are not material to our overall performance, we will, nonetheless, continue to work with FDA and explore all available options to ensure physicians and patients have continued access to this incredibly safe and important product."
The FDA published the warning letter, dated Dec. 20, on its website this week. The agency asked MiMedx to respond within 15 working days of receiving the letter.
MiMedx launched Axiofill in September 2022 for use in large, complex wounds and those of irregular geometries. The treatment can be applied directly as a dry particulate or by using saline to create a paste depending upon surgeon preference and clinical need.