Tissue Bank Customers

PriMatrix products are approved and regulated in the United States under the FDA’s Medical Devices regulation (21 CFR 820). As a result, PriMatrix is not considered either a biologic or a human tissue product, so the regulations for human tissue and biologics (21 CFR Parts 1270/1271) do not apply. Thus, there is no requirement to register as a tissue bank. Additionally, AATB Human Tissue Certifications do not apply. All PriMatrix products are terminally sterilized, shelf-stable at room temperature for up to 5 years, do not need refrigeration, and do not require special handling and tracking procedures as human tissue products do.

FDA Medical Device Regulations – Applicable to PriMatrix:
http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfcfr/CFRSearch.cfm?CFRPart=820

For Reference – For Tissue and Biologic Products (Do Not Apply to PriMatrix):
http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfcfr/CFRSearch.cfm?CFRPart=1270
http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfcfr/CFRSearch.cfm?CFRPart=1271
http://www.aatb.org/Certification