Title 21, Part 1271 — Human Cells, Tissues, and Cellular and Tissue-based Products
49 sections
Section 1271.1
What are the purpose and scope of this part?
Section 1271.3
How does FDA define important terms in this part?
Section 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?
Section 1271.15
Are there any exceptions from the requirements of this part?
Section 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?
Section 1271.21
When do I register, submit an HCT/P list, and submit updates?
Section 1271.22
How do I register and submit an HCT/P list?
Section 1271.23
How is a waiver from the electronic format requirements requested?
Section 1271.25
What information is required for establishment registration and HCT/P listing?
Section 1271.26
When must I amend my establishment registration?
Section 1271.27
Will FDA assign me a registration number?
Section 1271.37
Will establishment registrations and HCT/P listings be available for inspection, and how do I request information on registrations and listings?
Section 1271.45
What requirements does this subpart contain?
Section 1271.47
What procedures must I establish and maintain?
Section 1271.50
How do I determine whether a donor is eligible?
Section 1271.55
What records must accompany an HCT/P after the donor-eligibility determination is complete; and what records must I retain?
Section 1271.60
What quarantine and other requirements apply before the donor-eligibility determination is complete?
Section 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?
Section 1271.75
How do I screen a donor?
Section 1271.80
What are the general requirements for donor testing?
Section 1271.85
What donor testing is required for different types of cells and tissues?
Section 1271.90
Are there other exceptions and what labeling requirements apply?
Section 1271.145
Prevention of the introduction, transmission, or spread of communicable diseases.
Section 1271.150
Current good tissue practice requirements.
Section 1271.155
Exemptions and alternatives.
Section 1271.160
Establishment and maintenance of a quality program.
Section 1271.170
Personnel.
Section 1271.180
Procedures.
Section 1271.190
Facilities.
Section 1271.195
Environmental control and monitoring.
Section 1271.200
Equipment.
Section 1271.210
Supplies and reagents.
Section 1271.215
Recovery.
Section 1271.220
Processing and process controls.
Section 1271.225
Process changes.
Section 1271.230
Process validation.
Section 1271.250
Labeling controls.
Section 1271.260
Storage.
Section 1271.265
Receipt, predistribution shipment, and distribution of an HCT/P.
Section 1271.270
Records.
Section 1271.290
Tracking.
Section 1271.320
Complaint file.
Section 1271.330
Applicability.
Section 1271.350
Reporting.
Section 1271.370
Labeling.
Section 1271.390
Applicability.
Section 1271.400
Inspections.
Section 1271.420
HCT/Ps offered for import.
Section 1271.440
Orders of retention, recall, destruction, and cessation of manufacturing.