Regenerative medicine company MiMedx Group has commented on a draft guidance from the U.S. Food and Drug Administration (FDA) regarding cell- and tissue-based products.
MiMedx uses human amniotic tissue to develop products and therapies for dental and other sectors of healthcare. The FDA published its draft guidance on minimal manipulation of human cells, tissues, and cellular and tissue-based products (HCT/Ps) for comment on December 23, 2014. The guidance reads, in part, as follows:
FDA defines articles containing or consisting of human cells or tissues that are intended for implantation, transplantation, infusion or transfer into a human recipient as "human cells, tissues, or cellular or tissue-based products" (HCT/Ps) in Title 21 of the Code of the Federal Regulations (CFR) Part 1271, specifically 21 CFR 1271.3(d). The Agency regulates HCT/Ps with a tiered, risk-based approach designed to provide the appropriate level of oversight to protect the public health. We, FDA, are issuing this guidance to provide you, sponsors, clinicians, and other establishments that manufacture and use HCT/Ps from adipose tissue, with recommendations for complying with the regulatory requirements for HCT/Ps, as set forth in 21 CFR Part 1271, as established under the authority of section 361 of the Public Health Service (PHS) Act as well as recommendations for complying with section 351 of the PHS Act and the Federal Food, Drug, and Cosmetic (FD&C) Act, and the applicable regulations.
Parker Petit, MiMedx's chairman and CEO, said in a release that the company is pleased the FDA is involving industry participants and others in the regulation process for HCT/Ps.
"We believe we have much to contribute to this topic and welcome the opportunity to provide our comments," he said.
Petit also commented on the company's financial forecast, noting that MiMedx does not expect the draft guidance to affect its ability to achieve anticipated revenue. He said the company will exceed the upper end of its revenue guidance for the fourth-quarter and full year of 2014, with more details to come in mid-January.
