Tissue Banking Regulations & Standards Flashcards
7 cards from real CTBS practice questions. Tap to flip, then mark Knew It or Still Learning — missed cards come back until you master them.
Read the first 7 Tissue Banking Regulations & Standards flashcards as text
Under FDA 21 CFR Part 1271, which of the following is classified as a Human Cells, Tissues, and Cellular and Tissue-Based Product (HCT/P)?
Answer: Corneal tissue for transplantation
Corneal tissue is an HCT/P regulated under 21 CFR Part 1271, whereas whole blood, vascularized organs, and secreted products fall under different regulatory frameworks.
What is the primary purpose of the AATB Standards for Tissue Banking?
Answer: To establish voluntary accreditation benchmarks that exceed federal minimums
AATB Standards serve as voluntary accreditation criteria that typically exceed FDA regulatory minimums to promote best practices in tissue banking.
Which FDA regulation specifically addresses the registration and listing requirements for tissue establishments?
Answer: 21 CFR Part 1271 Subpart B
21 CFR Part 1271 Subpart B covers registration and listing requirements for HCT/P establishments with the FDA.
A tissue bank discovers a potential infectious disease transmission from an allograft. Under FDA regulations, this must be reported as a:
Answer: Biological Product Deviation Report (BPDR)
Biological Product Deviation Reports (BPDRs) are required under 21 CFR 1271.350 when an HCT/P may have caused or contributed to serious adverse reactions.
The AATB accreditation cycle for tissue banks requires re-inspection every:
Answer: 3 years
AATB requires accredited tissue banks to undergo re-inspection every three years to maintain their accreditation status.
Which of the following activities would trigger the need for a tissue bank to submit a Biologics License Application (BLA) to the FDA?
Answer: Manufacturing more than minimally manipulated allogeneic tissue for homologous use
HCT/Ps that are more than minimally manipulated or used for non-homologous purposes are regulated as biologics and require a BLA.
Under AATB Standards, which document must accompany each tissue distributed to a transplanting facility?
Answer: Tissue tracking form with required labeling information
AATB Standards require that distributed tissue be accompanied by a tracking form that includes all required labeling information to ensure traceability.