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FEDERAL · 21 CFR

Part 1271 — Human Cells, Tissues, and Cellular and Tissue-Based Products

49 sections · Title 21: Food and Drugs

§ 1271.1What are the purpose and scope of this part?
§ 1271.3How does FDA define important terms in this part?
§ 1271.10Are 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?
§ 1271.15Are there any exceptions from the requirements of this part?
§ 1271.20If 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?
§ 1271.21When do I register, submit an HCT/P list, and submit updates?
§ 1271.22How do I register and submit an HCT/P list?
§ 1271.23How is a waiver from the electronic format requirements requested?
§ 1271.25What information is required for establishment registration and HCT/P listing?
§ 1271.26When must I amend my establishment registration?
§ 1271.27Will FDA assign me a registration number?
§ 1271.37Will establishment registrations and HCT/P listings be available for inspection, and how do I request information on registrations and listings?
§ 1271.45What requirements does this subpart contain?
§ 1271.47What procedures must I establish and maintain?
§ 1271.50How do I determine whether a donor is eligible?
§ 1271.55What records must accompany an HCT/P after the donor-eligibility determination is complete; and what records must I retain?
§ 1271.60What quarantine and other requirements apply before the donor-eligibility determination is complete?
§ 1271.65How do I store an HCT/P from a donor determined to be ineligible, and what uses of the HCT/P are not prohibited?
§ 1271.75How do I screen a donor?
§ 1271.80What are the general requirements for donor testing?
§ 1271.85What donor testing is required for different types of cells and tissues?
§ 1271.90Are there other exceptions and what labeling requirements apply?
§ 1271.145Prevention of the introduction, transmission, or spread of communicable diseases.
§ 1271.150Current good tissue practice requirements.
§ 1271.155Exemptions and alternatives.
§ 1271.160Establishment and maintenance of a quality program.
§ 1271.170Personnel.
§ 1271.180Procedures.
§ 1271.190Facilities.
§ 1271.195Environmental control and monitoring.
§ 1271.200Equipment.
§ 1271.210Supplies and reagents.
§ 1271.215Recovery.
§ 1271.220Processing and process controls.
§ 1271.225Process changes.
§ 1271.230Process validation.
§ 1271.250Labeling controls.
§ 1271.260Storage.
§ 1271.265Receipt, predistribution shipment, and distribution of an HCT/P.
§ 1271.270Records.
§ 1271.290Tracking.
§ 1271.320Complaint file.
§ 1271.330Applicability.
§ 1271.350Reporting.
§ 1271.370Labeling.
§ 1271.390Applicability.
§ 1271.400Inspections.
§ 1271.420HCT/Ps offered for import.
§ 1271.440Orders of retention, recall, destruction, and cessation of manufacturing.