MiMedx Falls on FDA Warning Letter For Axiofill Classification

MiMedx said it received a warning letter from the FDA over the classification of Axiofill. The company does not agree with the FDA’s position.

• “Following a routine inspection earlier in the year” the FDA said Axiofill does not meet the requirements as a Section 361 product and is therefore subject to enforcement as a Section 351 product
• “Specifically, FDA asserts that the production of Axiofill involves more than ‘minimal manipulation.’”
• Does not agree with FDA’s position and has been actively engaged with the agency through its Request For Designation process
• Reiterates guidance for FY net sales in the high-teens and ...