The safety of our products and technologies is our main priority. RegenTX maintains a current FDA establishment registration and listing for all manufactured products for packaging, processing, storage, labeling and distribution. We also hold an accreditation with the American Association of Tissue Banks.
RegenTX manufactures human cells, tissues, and cellular and tissue-based products (HCT/Ps) that are regulated solely under the authority of section 361 of the Public Health Service Act (the PHS Act) as described in 21 CFR 1271.10.
All products manufactured by RegenTX meet the following criteria:
At RegenTX, we engage with external recovery partners for donor authorization/informed consent and recovery, collection, and/or acquisition of donated human tissue.
As we hold the safety and quality of our products to the highest Standard, we only engage with recovery partners who maintain compliance with FDA 21 CFR 1271 and AATB standards. Our partners are committed to providing stewardship for the gift of donated human tissue and to taking the utmost care in the recovery, collection, and/or acquisition process.
Donors and/or their families are gently approached and educated on the opportunity for donation. After authorization/informed consent for donation is obtained, recovery, collection, or acquisition is performed using aseptic or clean techniques appropriate to the specific tissue type and intended use.
All donors are carefully evaluated in accordance with FDA and AATB standards for considerable risk behaviors and relevant communicable diseases to ensure safety of the donated tissue.
Since we recognize the instrumental role that quality holds to ensure the safety of our products, we have worked hard to build a strong quality system and team. All policies and procedures are designed to meet or exceed FDA requirements under 21 CFR 1271 and AATB Standards. Our Quality Assurance Program oversees quality event management, document control, record management, validation/qualification activities, quality/labeling/purchasing control, training, and reviews, approval, and release of donor records and batch records.
Quality is built into our critical processes and support activities to provide evidence and verification of compliance.Our experienced quality team works to ensure that the entire operation is in conformity with the FDA regulations, AATB standards, and internal procedures. The suitability and effectiveness of the quality system is routinely evaluated at defined intervals.
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