CTBS Regulatory Standards 4 — Questions and Answers
Question 1: What is the purpose of an Establishment Inspection Report (EIR) issued by the FDA following a tissue bank inspection?
- To certify the tissue bank for distribution of a new tissue type
- To document the findings of an FDA investigator during an inspection (Correct answer)
- To grant AATB accreditation to the inspected facility
- To serve as the tissue bank's annual registration renewal
Correct answer: To document the findings of an FDA investigator during an inspection
An EIR is the official FDA document summarizing the observations and findings of an FDA investigator during a facility inspection.
Question 2: Which form does the FDA use to communicate objectionable conditions observed during a tissue bank inspection?
- Form FDA 483 (Correct answer)
- Form FDA 1571
- Form FDA 356h
- Form FDA 2541
Correct answer: Form FDA 483
Form FDA 483 (Inspectional Observations) is issued to the tissue bank's management at the close of an inspection to list objectionable conditions found.
Question 3: Under 21 CFR 1271.60, what is required before a tissue establishment changes ownership?
- The new owner must file a new establishment registration before beginning operations (Correct answer)
- The previous owner must transfer FDA registration by mail
- No regulatory action is required if operations continue unchanged
- AATB must approve the ownership transfer first
Correct answer: The new owner must file a new establishment registration before beginning operations
When ownership of a tissue establishment changes, the new owner must register with FDA as a new establishment before resuming operations.
Question 4: Which of the following is NOT a criterion for classifying an HCT/P as a 361 product regulated solely under the PHS Act?
- Minimal manipulation
- Homologous use
- Manufactured in an ISO 7 cleanroom (Correct answer)
- No systemic effect or dependence on metabolic activity
Correct answer: Manufactured in an ISO 7 cleanroom
Cleanroom classification is a manufacturing control but not one of the four regulatory criteria that determine 361 HCT/P status under 21 CFR 1271.10.
Question 5: Under AATB Standards, which professional is responsible for making the final donor eligibility determination?
- Any trained tissue bank technician
- The Medical Director or designated physician (Correct answer)
- The procurement coordinator who recovered the tissue
- A registered nurse with tissue banking experience
Correct answer: The Medical Director or designated physician
AATB Standards assign final donor eligibility determination to the Medical Director or a designated licensed physician, ensuring medical accountability.
Question 6: What does 'homologous use' mean in the context of HCT/P regulation?
- Using tissue in the same individual from whom it was recovered
- Repairing, reconstructing, replacing, or supplementing a recipient's tissue with tissue that performs the same basic function (Correct answer)
- Using identical tissue from genetically related donors
- Processing tissue so that all cellular material is removed
Correct answer: Repairing, reconstructing, replacing, or supplementing a recipient's tissue with tissue that performs the same basic function
Homologous use means the HCT/P is used to perform the same basic function or functions in the recipient as in the donor, as defined in 21 CFR 1271.3(c).
Question 7: Under Good Tissue Practice (GTP), what must be established to prevent contamination during tissue processing?
- A validated environmental monitoring program for processing areas (Correct answer)
- Full genome sequencing of all processing personnel
- Use of single-use disposable cleanroom suits for every procedure
- Daily sterilization of all processing equipment with ethylene oxide
Correct answer: A validated environmental monitoring program for processing areas
21 CFR 1271.195 requires tissue establishments to establish and maintain environmental controls, including monitoring of air quality and other environmental conditions in processing areas.
CTBS Regulatory Standards 4
What is the purpose of an Establishment Inspection Report (EIR) issued by the FDA following a tissue bank inspection?