CTBS Regulatory Standards 2 — Questions and Answers
Question 1: Under 21 CFR Part 1271, which category of HCT/Ps is subject to the least regulatory oversight?
- 361 HCT/Ps meeting all criteria for minimal manipulation and homologous use (Correct answer)
- 351 HCT/Ps requiring a BLA
- HCT/Ps combined with a drug
- HCT/Ps used in non-homologous applications
Correct answer: 361 HCT/Ps meeting all criteria for minimal manipulation and homologous use
361 HCT/Ps that meet criteria for minimal manipulation, homologous use, no systemic effect, and no combination with drugs/devices are regulated solely under Section 361 of the PHS Act.
Question 2: What is the primary purpose of the AATB's Accreditation Program?
- To replace FDA registration requirements
- To ensure tissue banks meet established standards for safety, quality, and efficacy (Correct answer)
- To certify individual tissue bank employees
- To regulate tissue pricing across member institutions
Correct answer: To ensure tissue banks meet established standards for safety, quality, and efficacy
AATB accreditation verifies that a tissue bank operates in accordance with AATB Standards, promoting safety and quality in tissue banking.
Question 3: How frequently must FDA-registered tissue establishments update their registration information if there are no changes?
- Monthly
- Every 6 months
- Annually (Correct answer)
- Every 3 years
Correct answer: Annually
Under 21 CFR Part 1271, tissue establishments must renew their registration with FDA annually, even if no information has changed.
Question 4: Which document must accompany a tissue allograft to ensure traceability from donor to recipient?
- A Certificate of Conformance only
- A donor summary sheet only
- Labeling that enables tracking from donor to consignee and consignee to donor (Correct answer)
- A chain of custody form signed by the surgeon
Correct answer: Labeling that enables tracking from donor to consignee and consignee to donor
21 CFR 1271.290 requires labeling that enables tracking from donor to consignee and from consignee to donor to maintain complete traceability.
Question 5: Under AATB Standards, what must be documented in a tissue bank's Standard Operating Procedures (SOPs)?
- Only critical processing steps
- All activities that affect the safety, quality, and efficacy of tissue (Correct answer)
- Financial and billing procedures only
- Only donor eligibility determination processes
Correct answer: All activities that affect the safety, quality, and efficacy of tissue
AATB Standards require SOPs to cover all activities that could affect tissue safety, quality, and efficacy, ensuring comprehensive procedural documentation.
Question 6: What is the regulatory consequence of distributing a tissue allograft from a donor later found to be ineligible?
- The tissue bank must notify FDA and may need to initiate a recall (Correct answer)
- No action is required if the tissue has already been transplanted
- Only the receiving facility must be notified
- The tissue bank loses accreditation automatically
Correct answer: The tissue bank must notify FDA and may need to initiate a recall
Under 21 CFR 1271.320, if a donor is later determined to be ineligible, the tissue bank must notify FDA and consignees, and may be required to recall distributed tissue.
Question 7: Which federal agency has primary regulatory authority over human tissue intended for transplantation in the United States?
- Centers for Disease Control and Prevention (CDC)
- Food and Drug Administration (FDA) (Correct answer)
- Health Resources and Services Administration (HRSA)
- Centers for Medicare & Medicaid Services (CMS)
Correct answer: Food and Drug Administration (FDA)
The FDA, under its authority from the Public Health Service Act and the Food, Drug, and Cosmetic Act, has primary regulatory jurisdiction over human tissues intended for transplantation.
CTBS Regulatory Standards 2
Under 21 CFR Part 1271, which category of HCT/Ps is subject to the least regulatory oversight?