The company has developed and implemented a quality management system in compliance with both the Food and Drug Administration (FDA) and the American Association of Tissue Banks (AATB). Using this quality management system, the company maintains strict control over each step of the manufacturing process.
In addition to regulating recovery and processing activities, the company has also established guidelines for donor eligibility, screening and testing. All donor records and test results are reviewed by our medical director prior to the release of the tissue. Only tissues that are deemed suitable for transplant are released for use.
What Does MIMEDX Do to Protect Safety?
Our products have been used to help thousands of patients for many years without significant reported safety problems. To ensure the safety of human tissue products, the U.S. Food and Drug Administration (FDA) enforces Good Tissue Practice (GTP) manufacturing regulations. We comply with these regulations. As an important part of our manufacturing safety compliance, our products are sterilized to an internationally recognized industry standard. Our most recent FDA inspection for compliance with GTP regulations took place in September 2018. It was closed out with no 483 observations and no action indicated (NAI), which is the most favorable designation FDA provides after an inspection.
In recent years, for complex regulatory reasons, FDA has begun an initiative to require that certain human tissue products meet additional requirements that apply to traditional biologic products, such as Biologic License Application (BLA) approval and current Good Manufacturing Practice (cGMP). This initiative applies to products offered by many companies, not just MIMEDX. Because the initiative requires industry changes, FDA has offered a transition period until November 2020 in which these requirements will not be enforced, except for true safety concerns. Accordingly, FDA is allowing these products to be marketed under the GTP regulation during the transition period in which cGMP compliance is being added to baseline GTP compliance.
MIMEDX is committed to making the FDA required transition. We are actively conducting clinical trials under FDA’s Investigational New Drug (IND) regulations and oversight to support BLA approval of our micronized dHACM product to treat specific musculoskeletal indications. We also have been re engineering our manufacturing process to meet the additional cGMP standard that will apply as of November 2020. We have made significant progress in doing so, and we plan to complete the transition by November 2020.
MIMEDX Amniotic Allografts Are Terminally Sterilized to Enhance Safety Related to Microbiological and Viral Transmission
In light of the media attention and in the wake of concerns related to the Coronavirus (COVID-19), the Company is reiterating its long standing processing safety standards for the terminal sterilization of MIMEDX amniotic allografts. The MIMEDX flagship amniotic allografts have always been terminally sterilized, and the Company’s proprietary PURION®
process has continually used terminal sterilization as an essential part of the process. To address potential questions related to COVID-19, MIMEDX is reconfirming the rigorous product safety methods and practices followed by the Company in the processing of its amniotic allografts as well as restating its precise standards for screening of placenta donors.
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FDA Adverse Reaction Investigation and Reporting Guidance Update
The FDA has issued a guidance document that provides recommendations complying with the requirements under 21 CFR Part 1271, Subparts D and E. The scope of the guidance involves the investigation and reporting of complaints concerning adverse reactions involving communicable diseases in recipients of 361 Human Cells, Tissues, and Cellular and Tissue-Based Products (HCT/Ps). MIMEDX assessed the Company’s compliance to the regulation and this guidance while it was in draft form during its public comment period that began in Q1 2015 and ended in Q4 of 2015. This assessment found that MIMEDX’S procedures and records were already in full compliance with the FDA’s Adverse Reaction regulations and are consistent with the new Guidance for HCT/Ps.
Licenses and Accreditations
To ensure patient safety, donor screening and testing is performed for each donor mother. Donor screening includes a review of both the donor’s medical and social history to ensure that the donor has not engaged in behaviors that place her at an increased risk for the transmission of infectious disease, and to ensure that the donor has not shown signs or symptoms of illnesses.
In addition, each donor is tested for the following infectious diseases:
- Hepatitis B
- Hepatitis C
- WNV based on exposure risk per FDA Guidance for Industry
All screening and testing results are reviewed according to the company’s quality management system, which is designed to meet the requirements specified in the FDA’s Good Tissue Practice regulations and in the standards of the American Association of Tissue Banks. All donor screening and testing records are reviewed and accepted by QA personnel before being reviewed by our medical director, a recognized expert in infectious disease testing. Only tissue from donors with acceptable test results are released for transplant.
The company is registered with the Food and Drug Administration and licensed as a tissue bank by the states of California, Georgia, Maryland, and New York. The company is compliant with the tissue bank guidelines of the American Association of Tissue Banks as well as all applicable federal, state, and local regulations