Part 1271 — Human Cells, Tissues, and Cellular and Tissue-Based Products
Subpart A — General Provisions
- § 1271.1— What are the purpose and scope of this part?
- § 1271.3— How does FDA define important terms in this part?
- § 1271.10— Are my HCT/P's regulated solely under section 361 of the PHS Act and the regulations in this part, and if so what must I do?
- § 1271.15— Are there any exceptions from the requirements of this part?
- § 1271.20— If my HCT/P's do not meet the criteria in § 1271.10, and I do not qualify for any of the exceptions in § 1271.15, what regulations apply?
Subpart B — Procedures for Registration and Listing
- § 1271.21— When do I register, submit an HCT/P list, and submit updates?
- § 1271.22— How do I register and submit an HCT/P list?
- § 1271.23— How is a waiver from the electronic format requirements requested?
- § 1271.25— What information is required for establishment registration and HCT/P listing?
- § 1271.26— When must I amend my establishment registration?
- § 1271.27— Will FDA assign me a registration number?
- § 1271.37— Will establishment registrations and HCT/P listings be available for inspection, and how do I request information on registrations and listings?
Subpart C — Donor Eligibility
- § 1271.45— What requirements does this subpart contain?
- § 1271.47— What procedures must I establish and maintain?
- § 1271.50— How do I determine whether a donor is eligible?
- § 1271.55— What records must accompany an HCT/P after the donor-eligibility determination is complete; and what records must I retain?
- § 1271.60— What quarantine and other requirements apply before the donor-eligibility determination is complete?
- § 1271.65— How do I store an HCT/P from a donor determined to be ineligible, and what uses of the HCT/P are not prohibited?
- § 1271.75— How do I screen a donor?
- § 1271.80— What are the general requirements for donor testing?
- § 1271.85— What donor testing is required for different types of cells and tissues?
- § 1271.90— Are there other exceptions and what labeling requirements apply?
Subpart D — Current Good Tissue Practice
- § 1271.145— Prevention of the introduction, transmission, or spread of communicable diseases.
- § 1271.150— Current good tissue practice requirements.
- § 1271.155— Exemptions and alternatives.
- § 1271.160— Establishment and maintenance of a quality program.
- § 1271.170— Personnel.
- § 1271.180— Procedures.
- § 1271.190— Facilities.
- § 1271.195— Environmental control and monitoring.
- § 1271.200— Equipment.
- § 1271.210— Supplies and reagents.
- § 1271.215— Recovery.
- § 1271.220— Processing and process controls.
- § 1271.225— Process changes.
- § 1271.230— Process validation.
- § 1271.250— Labeling controls.
- § 1271.260— Storage.
- § 1271.265— Receipt, predistribution shipment, and distribution of an HCT/P.
- § 1271.270— Records.
- § 1271.290— Tracking.
- § 1271.320— Complaint file.