The FDA requires records that detail the traceability of donated tissues from the donor to the recipient. Each product contains a tissue tracking record and corresponding product stickers with a unique identifier and lot number. Complete the tissue tracking record, apply the product stickers and return to Singularity Biosciences within five (5) days of the procedure.Return the completed tissue tracking record to:Singularity Biosciences, Inc.
PO Box 7516
Newport Beach, CA 92658
email@singularitybioscience.com
Recommended Tissue Tracking Protocols
To ensure compliance with FDA regulations and maintain the highest standards of patient safety, the following tissue tracking protocols are recommended.
- Each unit of tissue is assigned a unique identifier, including a lot number and expiration date, as indicated on the product labeling. The identifier must be used for all documentation and tracking purposes.
- Upon receipt, the tissue should be inspected for integrity, proper labeling and alignment with accompanying documentation. Any discrepancies or damage must be reported immediately, and the tissue should be quarantined until resolution.
- Before distribution use, verify the unique identifier against the order and patient information to ensure proper allocation. Maintain a record of the recipient, including contact details and delivery confirmation.
- All steps of the tissue handling process, from receipt to final disposition, must be documented in a traceable manner. Records must include the unique identifier, date of use or disposition.
- All records must be retained for a minimum of 10 years, or longer if required by state or federal guidelines.
