Regulatory 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 Regulatory Standards flashcards as text
What is the purpose of an Establishment Inspection Report (EIR) issued by the FDA following a tissue bank inspection?
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.
Which form does the FDA use to communicate objectionable conditions observed during a tissue bank inspection?
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.
Under 21 CFR 1271.60, what is required before a tissue establishment changes ownership?
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.
Which of the following is NOT a criterion for classifying an HCT/P as a 361 product regulated solely under the PHS Act?
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.
Under AATB Standards, which professional is responsible for making the final donor eligibility determination?
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.
What does 'homologous use' mean in the context of HCT/P regulation?
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).
Under Good Tissue Practice (GTP), what must be established to prevent contamination during tissue processing?
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.