| 21:8.0.1.5.60.1 | SUBPART A
| Subpart A - General Provisions | |
| 21:8.0.1.5.60.1.1.1 | SECTION 1271.1
| 1271.1 What are the purpose and scope of this part | |
| 21:8.0.1.5.60.1.1.2 | SECTION 1271.3
| 1271.3 How does FDA define important terms in this part | |
| 21:8.0.1.5.60.1.1.3 | SECTION 1271.10
| 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 | |
| 21:8.0.1.5.60.1.1.4 | SECTION 1271.15
| 1271.15 Are there any exceptions from the requirements of this part | |
| 21:8.0.1.5.60.1.1.5 | SECTION 1271.20
| 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 | |
| 21:8.0.1.5.60.2 | SUBPART B
| Subpart B - Procedures for Registration and Listing | |
| 21:8.0.1.5.60.2.1.1 | SECTION 1271.21
| 1271.21 When do I register, submit an HCT/P list, and submit updates | |
| 21:8.0.1.5.60.2.1.2 | SECTION 1271.22
| 1271.22 How do I register and submit an HCT/P list | |
| 21:8.0.1.5.60.2.1.3 | SECTION 1271.23
| 1271.23 How is a waiver from the electronic format requirements requested | |
| 21:8.0.1.5.60.2.1.4 | SECTION 1271.25
| 1271.25 What information is required for establishment registration and HCT/P listing | |
| 21:8.0.1.5.60.2.1.5 | SECTION 1271.26
| 1271.26 When must I amend my establishment registration | |
| 21:8.0.1.5.60.2.1.6 | SECTION 1271.27
| 1271.27 Will FDA assign me a registration number | |
| 21:8.0.1.5.60.2.1.7 | SECTION 1271.37
| 1271.37 Will establishment registrations and HCT/P listings be available for inspection, and how do I request information on registrations and listings | |
| 21:8.0.1.5.60.3 | SUBPART C
| Subpart C - Donor Eligibility | |
| 21:8.0.1.5.60.3.1.1 | SECTION 1271.45
| 1271.45 What requirements does this subpart contain | |
| 21:8.0.1.5.60.3.1.2 | SECTION 1271.47
| 1271.47 What procedures must I establish and maintain | |
| 21:8.0.1.5.60.3.1.3 | SECTION 1271.50
| 1271.50 How do I determine whether a donor is eligible | |
| 21:8.0.1.5.60.3.1.4 | SECTION 1271.55
| 1271.55 What records must accompany an HCT/P after the donor-eligibility determination is complete; and what records must I retain | |
| 21:8.0.1.5.60.3.1.5 | SECTION 1271.60
| 1271.60 What quarantine and other requirements apply before the donor-eligibility determination is complete | |
| 21:8.0.1.5.60.3.1.6 | SECTION 1271.65
| 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 | |
| 21:8.0.1.5.60.3.1.7 | SECTION 1271.75
| 1271.75 How do I screen a donor | |
| 21:8.0.1.5.60.3.1.8 | SECTION 1271.80
| 1271.80 What are the general requirements for donor testing | |
| 21:8.0.1.5.60.3.1.9 | SECTION 1271.85
| 1271.85 What donor testing is required for different types of cells and tissues | |
| 21:8.0.1.5.60.3.1.10 | SECTION 1271.90
| 1271.90 Are there other exceptions and what labeling requirements apply | |
| 21:8.0.1.5.60.4 | SUBPART D
| Subpart D - Current Good Tissue Practice | |
| 21:8.0.1.5.60.4.1.1 | SECTION 1271.145
| 1271.145 Prevention of the introduction, transmission, or spread of communicable diseases. | |
| 21:8.0.1.5.60.4.1.2 | SECTION 1271.150
| 1271.150 Current good tissue practice requirements. | |
| 21:8.0.1.5.60.4.1.3 | SECTION 1271.155
| 1271.155 Exemptions and alternatives. | |
| 21:8.0.1.5.60.4.1.4 | SECTION 1271.160
| 1271.160 Establishment and maintenance of a quality program. | |
| 21:8.0.1.5.60.4.1.5 | SECTION 1271.170
| 1271.170 Personnel. | |
| 21:8.0.1.5.60.4.1.6 | SECTION 1271.180
| 1271.180 Procedures. | |
| 21:8.0.1.5.60.4.1.7 | SECTION 1271.190
| 1271.190 Facilities. | |
| 21:8.0.1.5.60.4.1.8 | SECTION 1271.195
| 1271.195 Environmental control and monitoring. | |
| 21:8.0.1.5.60.4.1.9 | SECTION 1271.200
| 1271.200 Equipment. | |
| 21:8.0.1.5.60.4.1.10 | SECTION 1271.210
| 1271.210 Supplies and reagents. | |
| 21:8.0.1.5.60.4.1.11 | SECTION 1271.215
| 1271.215 Recovery. | |
| 21:8.0.1.5.60.4.1.12 | SECTION 1271.220
| 1271.220 Processing and process controls. | |
| 21:8.0.1.5.60.4.1.13 | SECTION 1271.225
| 1271.225 Process changes. | |
| 21:8.0.1.5.60.4.1.14 | SECTION 1271.230
| 1271.230 Process validation. | |
| 21:8.0.1.5.60.4.1.15 | SECTION 1271.250
| 1271.250 Labeling controls. | |
| 21:8.0.1.5.60.4.1.16 | SECTION 1271.260
| 1271.260 Storage. | |
| 21:8.0.1.5.60.4.1.17 | SECTION 1271.265
| 1271.265 Receipt, predistribution shipment, and distribution of an HCT/P. | |
| 21:8.0.1.5.60.4.1.18 | SECTION 1271.270
| 1271.270 Records. | |
| 21:8.0.1.5.60.4.1.19 | SECTION 1271.290
| 1271.290 Tracking. | |
| 21:8.0.1.5.60.4.1.20 | SECTION 1271.320
| 1271.320 Complaint file. | |
| 21:8.0.1.5.60.5 | SUBPART E
| Subpart E - Additional Requirements for Establishments Described in § 1271.10 | |
| 21:8.0.1.5.60.5.1.1 | SECTION 1271.330
| 1271.330 Applicability. | |
| 21:8.0.1.5.60.5.1.2 | SECTION 1271.350
| 1271.350 Reporting. | |
| 21:8.0.1.5.60.5.1.3 | SECTION 1271.370
| 1271.370 Labeling. | |
| 21:8.0.1.5.60.6 | SUBPART F
| Subpart F - Inspection and Enforcement of Establishments Described in § 1271.10 | |
| 21:8.0.1.5.60.6.1.1 | SECTION 1271.390
| 1271.390 Applicability. | |
| 21:8.0.1.5.60.6.1.2 | SECTION 1271.400
| 1271.400 Inspections. | |
| 21:8.0.1.5.60.6.1.3 | SECTION 1271.420
| 1271.420 HCT/Ps offered for import. | |
| 21:8.0.1.5.60.6.1.4 | SECTION 1271.440
| 1271.440 Orders of retention, recall, destruction, and cessation of manufacturing. | |