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
The FDA's 'same surgical procedure' exception under 21 CFR 1271.15(b) allows a physician to use HCT/Ps without full regulation if the tissue is:
Answer: Removed from and implanted into the same individual during the same surgical procedure
The same surgical procedure exception applies only when the HCT/P is removed from and implanted back into the same patient during a single procedure.
Which AATB Standard section specifically addresses donor suitability determination?
Answer: Section D — Donor Evaluation
AATB Section D covers Donor Evaluation, which includes the criteria and processes for determining donor suitability.
A tissue bank receives a complaint that a processed bone allograft contained unexpected particulate matter. Under ISO 13485, this complaint must be:
Answer: Evaluated to determine if it constitutes a reportable event to FDA
ISO 13485 and FDA regulations require all complaints to be evaluated to determine whether they represent reportable events, regardless of whether implantation occurred.
Under FDA 21 CFR Part 1271.90, what is the required minimum retention period for donor eligibility records?
Answer: At least 10 years after distribution, transplantation, or disposal
FDA requires donor eligibility records to be retained for at least 10 years after the date of administration, transplantation, or disposal of the associated HCT/P.
Which of the following best describes 'homologous use' as defined in FDA's HCT/P regulations?
Answer: Performing the same basic function in the recipient as in the donor
Homologous use means the HCT/P performs the same basic function or functions in the recipient as it performed in the donor.
AATB Standards require that a medical director of a tissue bank must be:
Answer: A licensed physician responsible for medical and technical policies
AATB Standards specify that the medical director must be a licensed physician who is responsible for the medical and technical policies of the tissue bank.
An FDA inspection of a tissue bank focuses on compliance with 21 CFR Part 1271. Which type of inspection specifically evaluates donor eligibility and infectious disease testing processes?
Answer: Compliance Program 7341.002 Inspection
FDA's Compliance Program 7341.002 governs inspections of HCT/P establishments and covers donor eligibility determination, infectious disease testing, and current good tissue practice.