To receive a single copy of the draft guidance - Draft Guidance for Industry: Current Good Tissue Practice
(CGTP) and Additional Requirements for Manufactures of Human Cells, Tissues, and Cellular and Tissue-Based Products (HCT/Ps) Availability, write: Office of Communication, Training, and Manufacturers Assistance (HFM-40), Center for Biologics Evaluation and Research (CBER), Food and Drug Administration, 1401 Rockville Pike, Suite 200N, Rockville, MD 20852-1448.
.to determine compliance under applicable requirements, including; (1) that human cells, tissues, or cellular or tissue-based products are obtained by the establishment legally; (2) that donor eligibility and donor medical history interviews are based on accurate information that was not provided or obtained in a fraudulent manner; and (3) current good tissue practice
Entitled "Current Good Tissue Practice
for Human Cell, Tissue and Cellular and Tissue-Based Establishments: Inspection and Enforcement," the rule requires manufacturers to recover, store, label, package and distribute human cells, tissues and cellular and tissue-based products (HCT/Ps) in a way that prevents the introduction, transmission, or spread of communicable diseases.
To comply with the regulation, HCT/Ps must undergo donor screening and testing for communicable disease, and manufacturers must follow current Good Tissue Practices
MiMedx Group provided additional background and context to certain points, including third party statements, in an article published by The Wall Street Journal on August 14, 2018: MiMedx products are manufactured according to current Good Tissue Practices
standards, pursuant to the FDA regulations specified in 21 CFR 1271, which are the requirements and guidelines the Company must follow.
The ESI hES cell lines were derived using procedures and documentation that are in compliance with current Good Tissue Practices
(cGTP) and current Good Manufacturing Practices (cGMP), are free of animal feeder cells and have been assessed for pluripotency and karyotypic stability.
The Food and Drug Administration (FDA) is seeking comments from the tissue transplant community on the agency's information collection regulations related to human cells, tissues, and cellular and tissue-based products (HCT/Ps) involving establishment registration and listing using Form FDA 3356; eligibility determination for donors; and current good tissue practices
Our clinical grade hES cell lines were derived using procedures and documentation that are in compliance with current Good Tissue Practices
(cGTP) and cGMP, which we believe will facilitate the transition of therapeutic products derived by researchers from these cell lines from laboratory to clinical use.
FDA will issue guidance on Current Good Tissue Practices
that will encourage tissue manufacturers to achieve best practices that can further reduce the risk of infection transmission.