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